Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing

Prepared for Shelley Hossenlopp on May 1, 2013

Caron Garstka | caron.garstka@gmail.com Elisa Salinas | esalinas@utexas.edu

Table of Contents
EXECUTIVE SUMMARY ...................................................................................... 3 POINT-OF-CARE (POC) MARKET ........................................................................ 3 RESEARCH ........................................................................................................ 4 a. PREGNANCY TESTS ...................................................................................... 4
US Market: Laboratory Blood Test .............................................................................5 US Market: OTC .........................................................................................................7 CDC US Birth Rate Highlights ....................................................................................7 World Market: OTC .....................................................................................................8 Hyperglycosylated HCG ...........................................................................................10 Misdiagnosed Pregnancies ......................................................................................10 Pregnancy Diagnoses...............................................................................................12 Companies in Pregnancy Test Kit Industry ..............................................................12 Capital IQ Pregnancy Test Kit Industry Companies ...............................................13

b. HIV & INFECTIOUS DISEASE ....................................................................... 14

POC Infectious Disease Market ................................................................................14 POC Infectious Disease Assays ................................................................................16 Abbott Laboratories ..............................................................................................16 Alere Inc. ..............................................................................................................16 bioLytical Laboratories Inc. ...................................................................................17 Chembio Diagnostics, Inc......................................................................................17 Grant Life Sciences, Inc. .......................................................................................17 OraSure Technologies Inc. ....................................................................................17 QuantRX Biomedical Corporation ..........................................................................18 Quest Diagnostics Inc. ..........................................................................................18 StatSure Diagnostic Systems, Inc. .........................................................................18 Thermal Gradient Inc. ...........................................................................................19 Trinity Biotech plc ................................................................................................19 MedMira Inc. ........................................................................................................19 Roche Diagnostics, Ltd .........................................................................................20 Early Infant Diagnosis (EID) of HIV ..........................................................................20

CONCLUSIONS AND RECOMMENDATIONS ..................................................... 22 SOURCES AND ADDITIONAL RESOURCES....................................................... 23

a. Websites ..............................................................................................................23 b. Magazines and Additional Resources ...................................................................24 c. Databases ............................................................................................................24 d. People .................................................................................................................24

Point-of-care (POC) Diagnostics Market

EXECUTIVE SUMMARY Shelley Hossenlopp is a professional consultant with global and domestic sales, distribution, marketing, business development and management in laboratory diagnostics in both the clinical and life science markets. Her client - Evik Diagnostics currently is seeking information on the point-of-care (POC) diagnostics market with a specific focus on the pregnancy and fertility market segment and the HIV and infectious disease market segment. Ms. Hossenlopp and her client will benefit from the information presented in this report as they consider where to allocate grant money. Our report compiles information about these two market segments to inform Ms. Hossenlopp about the terrain of both market segments. The outcome of this study is to inform the clients business strategy as they move forward in making a decision about which market to explore with their grant money. POINT-OF-CARE (POC) MARKET The term point-of-care (POC) diagnostics is generally defined as in vitro diagnostic (IVD) testing, meaning those that use bodily fluids extracted from the body such as blood, that is undertaken in the same location as the patient and that produces a result while the patient remains where the test was performed, facilitating faster diagnosis and treatment.1 POC diagnostics benefit patients and medical professionals by providing immediate diagnosis and treatment of diseases as opposed to delayed results and follow-up medical attention, saving time for both physicians and patients, preventing deteriorating health and risk of transmission for infected patients, and saving medical costs, a factor that is especially important in developing countries with limited financial resources and a significant need for medical testing. POC diagnostics is not recognized as a distinct product category by any regulatory body and its definition is therefore open to interpretation. There is debate as to the definition of where the point-of-care ends. For example, whether the test has to take place at the patients side or if it can be performed in the same hospital department the patient is in, but further away from the patient.2 FORECAST OF THE GLOBAL POC MARKET BY TEST TYPE, 2009-2016

Infectious Diseases Point of Care Diagnostics: Products Players and Outlook to 2017, Espicom Business Intelligence, February 2013 2 Ibid.

(USD MILLIONS)3

RESEARCH a. PREGNANCY TESTS The pregnancy test market segment can be broken down into two distinct parts: overthe-counter diagnostic products and blood derivative diagnostic agents. According to Highbeam Business, there was $1.68 billion in pregnancy test kits shipped in 2008, while blood derivative diagnostic agents manufacturers were valued at $276.0 million.4 According to a POC market report put out by Ben-Haim, the global market for pregnancy self-tests has been increasing due to womens preferences for confidentiality of the pregnancy test results, the accessibility of the test, rapid results of the diagnosis and the convenience of testing at home.5 This report goes on to state that pregnancy tests have the second largest POC market share, estimated in 2007 at US $700 million and growing at a rate of 5% per annum over the period to 2012.6 According to this report the competition in the pregnancy detection market is intense, and includes a large number of large and small players. Ben-Haim pegs Inverness Medical as the worldwide market leader for the consumer segment. 7 A report put out on PRweb.com by IBISWorld Market Research states that in the five years to 2012, revenue for the Pregnancy Test Kit Manufacturing industry declined at an average annual rate of 1.1% to an estimated $227.7 million.8 The report posits that the
Google: global market for point of care> Point of Care Diagnostics-BCC> http://www.bccresearch.com/report/point-of-care-diagnostics-market-hlc043c.html 4 http://business.highbeam.com/industry-reports/chemicals/in-vitro-in-vivo-diagnostic-substances 5 http://www.ictph.org.in/downloads/POC_Market.pdf 6 http://www.ictph.org.in/downloads/POC_Market.pdf 7 http://www.ictph.org.in/downloads/POC_Market.pdf 8 http://www.prweb.com/releases/2012/7/prweb9714926.htm
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reason for this decline is because the industry was adversely affected by poor economic conditions. The poor economic conditions resulted in a greater number of couples postponing having children as a result of heightened unemployment and greater financial insecurity.9 The report continues: Given that women who are planning pregnancy make up an estimated 60.0% of retail sales, this trend translated into lower downstream demand for pregnancy test kits manufactured by the industry. As a result, industry revenue declined steadily from 2008 to 2010, decreasing at an average annual rate of 3.8%.10 It is also important to note that the report makes the following about the Pregnancy Test Kit Manufacturing industry: This industry manufactures over-the-counter diagnostic products that test for chemical markers associated with pregnancy. Manufactured pregnancy tests typically test for the presence of the hormone human chorionic gonadotrophin (HCG). This industry excludes diagnostic tests that identify the presence of HCG through blood testing.11 Home pregnancy tests cost between $8 and $20. This is significantly less expensive than a blood test at a doctor's office or lab which costs approximately $45.12 Planned Parenthood offers free pregnancy tests and some follow-up care.1314 Other companies or other resource services provide free tests as well.15

US Market: Laboratory Blood Test According to the Vitae Clinic in Austin, Texas, obtaining numbers for test revenues or test volumes for the laboratory pregnancy test market segment is not possible. They explain:

Because of the use of over-the-counter pregnancy tests, lab testing is not done unless it is an unusual case or the woman is experiencing complications. Most times when women come into the office they either bring proof that they are
http://www.prweb.com/releases/2012/7/prweb9714926.htm http://www.prweb.com/releases/2012/7/prweb9714926.htm 11 http://www.prweb.com/releases/2012/7/prweb9714926.htm 12 http://www.ehow.com/facts_4843665_pregnancy-costs-usa.html 13 http://www.ehow.com/facts_4843665_pregnancy-costs-usa.html 14 http://www.plannedparenthood.org/mercer/free-pregnancy-testing32639.htm?__utma=1.418224686.1367505506.1367505506.1367505506.1&__utmb=1.14.9.1367505524 173&__utmc=1&__utmx=&__utmz=1.1367505506.1.1.utmcsr=google|utmccn=(organic)|utmcmd=organic|utmctr=(not%20provided) &__utmv=-&__utmk=117712905 15 http://www.agapeprc.org/services.php
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pregnant- so a pregnancy test the took at home which negates the need for us to test them - or we have them do a urine test in the office. There is usually no need for a blood test to be done.

The Vitae Clinic also mentioned the following:

The number of women who are in need of laboratory blood testing usually already know they are pregnant and are having blood tests to screen for other pregnancy related complications

This is corroborated by WebMD:

A quantitative hCG test (beta hCG) measures the exact amount of hCG in your blood. It can find even very low levels of hCG. Because these pregnancy tests can measure the concentration of hCG, they may be helpful in tracking any problems during pregnancy. They may also be used to rule out a tubal (ectopic) pregnancy or to monitor a woman after a miscarriage when hCG levels fall rapidly.16 Therefore, we have concluded that the laboratory blood test is now reserved for those women experiencing issues carrying a pregnancy to term or who are experiencing complications with their pregnancy and need to be monitored. Because there is no constant number of women having blood tests taken, the numbers are variable and according to the Vitae Clinic, getting the numbers of women doing blood tests would not be something available to you due to patient confidentiality. However, in order to estimate the number of women experiencing pregnancy complications and therefore estimate the laboratory test market size, we suggest looking through the following CDC reports for more information about pregnancy complications statistics: http://www.cdc.gov/reproductivehealth/MaternalInfantHealth/PregComplications.h tm http://www.cdc.gov/prams/PramsReport.html http://www.cdc.gov/prams/PDF/Snapshot-Report/Introduction.pdf http://www.healthypeople.gov/2020/topicsobjectives2020/nationaldata.aspx?topic Id=26 We also suggest looking at the following website put out by Healthypeople.gov for more information about pregnancy complications:

16

http://www.webmd.com/baby/guide/pregnancy-tests

http://www.healthypeople.gov/2020/topicsobjectives2020/objectiveslist.aspx?topi cId=26#90

US Market: OTC Data from the National Vital Statistics System published by NCHS show that about 4 million births occur in the United States each year.17 About 40% of the births in the United States in recent years are to unmarried women. In addition to the 4 million births, about 1 million miscarriages and stillbirths occur in the United States each year, and about 1.2 million abortions are performed.18 Each birth, whether it was successful or not, needs to be included in the over-the-counter (OTC) pregnancy test market. In 2010, a total of 3,999,386 births were registered in the United States, 3 percent less than in 2009 (4,130,665) and 7 percent less than the record number of births in 2007 (4,316,233).19 Approximately 1 in 68 or 1.47% or 4 million women in the US become pregnant every year. That breaks down into the following: "more than 4 million; 1 million adolescent U.S. females become pregnant every year."20 Additionally, the following information applies to the US:

CDC US Birth Rate Highlights 21 In 2010, 3,999,386 births were reported to U.S. residents, 3 percent less than in 2009 (4,130,665).The number of births declined for nearly all race and Hispanic origin groups. The general fertility rate was 64.1 births per 1,000 U.S. women aged 1544, down 3 percent from2009 (66.2). The total fertility rate (estimated number of births over a womans lifetime) was 1,931 births per 1,000 women in 2010, a 4 percent decline from 2009 (2,002). The birth rate for U.S. teenagers aged 1519 fell 10 percent in 2010, to 34.2 per 1,000, reaching the lowest level reported in the United States in seven decades. Rates declined for teen sub-groups aged 1014, 1517, and 1819 and for all race and Hispanic origin groups.

17

http://www.cdc.gov/nchs/data/series/sr_23/sr23_029.pdf http://www.cdc.gov/nchs/data/series/sr_23/sr23_029.pdf 19 http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_01.pdf 20 http://www.rightdiagnosis.com/p/pregnancy/prevalence.htm 21 http://www.cdc.gov/nchs/data/nvsr/nvsr61/nvsr61_01.pdf

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Birth rates declined among women of all age groups under age 40 from 2009 to 2010; the birth rate for women aged 4044 rose, and the rate per 1,000women aged 45 49was unchanged. The first-birth rate for women aged 1544 declined 3 percent to 25.9 births per 1,000 women in 2010. First-birth rates declined for women under age 30 and aged 3539, but rose for women aged 3034 and 4044. In 2010, the mean age of mother at first birth increased to 25.4 years from 25.2 in 2009. The mean age rose for nearly all race and Hispanic origin groups. Childbearing by unmarried women declined in 2010 for the second consecutive year, as reflected in fewer births (1,633,471) and a lower birth rate (47.6 per 1,000). The number of births declined almost 4 percent and the birth rate fell 5 percent, while the percentage The most current statistics found on birth rate was compiled from provisional data from the National Vital Statistics System, National Center for Health Statistics, and the CDC. See the attachment titled US Birth and Death 2012. Additionally, abortion rates must be considered to find the total number of pregnant women. According to a CDC Morbidity and Mortality Weekly Report, the following has been tracked on abortion: A total of 784,507 abortions were reported to CDC for 2009. Of these abortions, 772,630 (98.5%) were from the 45 reporting areas that provided data every year during 20002009. Among these same 45 reporting areas, the abortion rate for 2009 was 15.1 abortions per 1,000 women aged 1544 years, and the abortion ratio was 227 abortions per 1,000 live births. Compared with 2008, the total number and rate of reported abortions for 2009 decreased 5%, representing the largest single year decrease for the entire period of analysis. The abortion ratio decreased 2%. From 2000 to 2009, the total number, rate, and ratio of reported abortions decreased 6%, 7%, and 8%, respectively, to the lowest levels for 20002009.22 Additional abortion and fetal death statistics have been included as attachments. World Market: OTC The current overall world birth rate is 19 births/1,000 population.23 For a complete breakdown of birth rates by country, see the attached spreadsheet titled World Birth Rate.

22 23

http://www.cdc.gov/mmwr/preview/mmwrhtml/ss6108a1.htm?s_cid=ss6108a1_w https://www.cia.gov/library/publications/the-world-factbook/index.html

Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 9 In addition to world birth rates, abortion rates are also necessary to find the reach of the market. World Abortion Rate24

Figure 1 - Guttmacher Institute Global and Regional estimates of induced abortion, 1995, 2003, 2008

The natural rate of population growth arises from the birth rate minus the death rate and without including the effects of migration. Therefore, estimating a test volume number and test revenue number could be calculated by taking the birth rate and the number of women between the ages of 15 and 45 (this encompasses the range of women in their childbearing years excluding outliers) and figuring how many births occurred in every 1000 women in the population. In addition to this number, taking the abortion and the fetal death rate would yield a number indicating women who were pregnant but who either induced an abortion or aborted naturally. These two numbers (the actual number of births and the actual number of abortions and fetal deaths) taken together can give a sense of how many women were in a state of pregnancy. We reason that this formulation will give an approximation for how many women in the US and the World were pregnant and we can reason from this that each woman took at least one pregnancy test. This would give an estimate for the OTC test volume. To get a range of how much revenue is being generated by the pregnancy test kit market, we suggest taking the minimum cost and the maximum cost for a pregnancy test and multiplying these two extremes with the found test volume number to get a revenue range.

24

http://www.who.int/reproductivehealth/publications/unsafe_abortion/induced_abortion_2012.pdf

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing Both of these calculations are extremely inexact. This is because neither take into consideration the number of women who take pregnancy tests and find that they are not pregnant. Therefore, there is a large test volume segment and revenue segment that are unaccounted for. However, if we can find that a woman is seeking fertility treatment due to her trying to achieve a pregnancy but being unable to, this could be factored into the equation. According to Fertility Today, the incidence of infertility has continued to rise over the last ten years and it is estimated that it affects at least 11% of couples of reproductive age. This number represents over 10 million couples in the United States. About 2 million couples seek infertility treatments each year.25 According to the CDC, the number of women ages 15-44 who have ever used infertility services is 7.4 million.26 Hyperglycosylated HCG This test is currently licensed to Quest Diagnostics Laboratory.2728 This test can be ordered from any world-wide Quest Diagnostic Inc. It can also be ordered from the USA HCG reference service. Currently, there is no OTC device available that can specifically detect hCG-H.29 There is a hyperglycosylated HCG urine test that has been patented.30 Misdiagnosed Pregnancies A false positive test is caused by substances in the womans body interfering with the test. False negative tests usually occur with urine samples and usually are due to interference from medications, dilute urine samples, or errors in following testing directions.31 As of 2010, the USA hCG reference service used the Siemen's Immulite 1000 assay and identified 83 cases of false-positive hCG, 71 cases of aggressive gestational trophoblastic disease (GTD), 52 cases of minimally invasive GTD, 168 cases of quiescent GTD and 22 cases of placenta site trophoblastic tumor (PSTT). In addition, 103 cases of pituitary hCG have been identified, 60 cases of nontrophoblastic tumor, 4 cases of inherited hCG and 2 cases of Munchausen's syndrome.32
25 26

http://www.fertilitytoday.org/infertility.html http://www.cdc.gov/nchs/fastats/fertile.htm 27 http://www.rbej.com/content/pdf/1477-7827-10-24.pdf 28 https://www.questdiagnostics.com/testcenter/testguide.action?dc=TS_First_hCG 29 http://www.google.com/patents/US20110201122#backward-citations

30

http://www.google.com/patents/US8278109?dq=hyperglycosylated+hcg&hl=en&sa=X&ei=0YaC UbGZJJOc8wT_i4DAAg&ved=0CDUQ6AEwAA
Google search: average pregnancy diagnsois> Pregnancy, Normal> http://www.mdguidelines.com/pregnancy-normal/diagnosis 32 http://www.ncbi.nlm.nih.gov/pubmed/20493830
31

 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 11

Numerous aspects of a pregnancy can be misdiagnosed as a result of failure to test or inaccurate test results. Different problems can occur if the following are incorrect or inaccurate33: Existence of Pregnancy Nature of Pregnancy: whether uterine, ectopic, or multiple Calculation of Gestational Age

For a diagnosis of pregnancy, the following list of conditions have been mentioned in sources as possible alternative diagnoses to consider during the diagnostic process for pregnancy34: Menopause - also causes absent periods. Female athlete syndrome - causes absent periods. Eating disorders - thinness can cause absent periods. Ovarian cancer - if hormone levels are elevated without pregnancy. Ectopic pregnancy Enlarged uterus Ovarian tumour Hydatidiform mole

The other diseases for which pregnancy is listed as a possible alternative diagnosis in their lists include35:
33 34

Breast Cancer Galactorrhea Goiter Leiomyoma Mastalgia Menopause Muscle cramps Obesity Oligomenorrhea Polycystic ovary syndrome Premenstrual syndrome Prolactinoma

http://www.rightdiagnosis.com/p/pregnancy/misdiag.htm http://www.rightdiagnosis.com/p/pregnancy/misdiag.htm 35 http://www.rightdiagnosis.com/p/pregnancy/misdiag.htm

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing Superficial thrombophlebitis Telangiectasia Uterine fibroids Uterine leiomyoma Weight Gain36

Up to 50% of all ectopic pregnancies are misdiagnosed by emergency room personnel.37 However, only 2-5% of pregnancies are ever even affected by ectopic concerns.38
For more information about pregnancy misdiagnoses, we suggest you visit the following link: http://emedicine.medscape.com/article/262591-overview#aw2aab6b4

Pregnancy Diagnoses In general, over-the-counter or home pregnancy test kits can detect hCG in urine and become positive 9 to 12 days after conception. hCG can be detected in the serum in 5% of pregnant women 5 days after conception and in over 98% of pregnant women by 11 days after conception. Serum hCG tests have a low false positive rate of 0.01% to 2%.39 However, it is recommended that the woman wait at least a week after a missed period before taking a pregnancy test in order to get the most accurate results.40 The Vitae Clinic also notes that most patients she sees will be diagnosed as being pregnancy at about 5 to 6 weeks. In addition to OTC tests and blood tests, a physical exam can be performed to look for signs of pregnancy: The exam may reveal enlargement of the uterus on bimanual examination, softening of the uterus and cervix (Hegars sign) at 6 weeks, bluish color of the vagina (Chadwicks sign) at 8 to 10 weeks, and enlargement of the breasts. At 10 to 12 weeks, fetal heart tones can be heard through a special stethoscope. The uterus may be palpable low in the abdomen by 12 weeks.41

Companies in Pregnancy Test Kit Industry The IBISWorld report notes that the Pregnancy Test Kit Manufacturing industry is highly concentrated. As of 2012, there were 11 operators in the market. The report states that larger firms have now entered the market:
36 37 38 39

http://www.rightdiagnosis.com/p/pregnancy/misdiag.htm http://www.pregnancy-tips-and-advice.com/ectopic-pregnancy.html

http://www.pregnancy-tips-and-advice.com/ectopic-pregnancy.html Google search: average pregnancy diagnosis> Pregnancy, Normal> http://www.mdguidelines.com/pregnancy-normal/diagnosis 40 http://www.webmd.com/baby/guide/pregnancy-tests 41 Google search: average pregnancy diagnosis> Pregnancy, Normal> http://www.mdguidelines.com/pregnancy-normal/diagnosis

 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 13 Over the five years to 2012, market share concentration has grown. Although the number of industry firms has declined at an estimated average annual rate of 3.3% over the period, larger firms have entered the industry. In 2007, consumer goods giant Procter & Gamble Co. and leading diagnostic manufacturer Alere joined to form industry major player Swiss Precision Diagnostics. Other industry leaders include domestic manufacturers Church & Dwight and Johnson & Johnson, which compete through well-known brands like Clearblue, First Response and EPT. 42 The the companies listed in the table below are classified within the Pregnancy Test Kit industry by Capital IQ. For the full list of companies, see the attached Capital IQ industry spreadsheet. Capital IQ Pregnancy Test Kit Industry Companies
Company Name Description Parent Company

Abbott Laboratories, Certain Assets of Rapid Diagnostics Business

As of September 30, 2003, Abbott Laboratories, Certain Assets of Rapid Diagnostics Business was acquired by Alere Inc. Certain assets of rapid diagnostics business of Abbott Laboratories comprise the Fact plus pregnancy test, the Abbott TestPack, Abbott TestPack plus, and Signify lines of rapid diagnostics for testing needs that include strep throat, pregnancy, and drugs of abuse. The assets also include certain transferred and licensed intellectual property related to the products. Abbott Laboratories is based in Abbott Park, Illinois.

Alere Inc. (NYSE:ALR) (United States)

Advanced Clinical Systems International Pty Ltd., Consumer Pregnancy Test Business

Advanced Clinical Systems International Pty Ltd., Consumer Pregnancy Test Business was acquired by Inverness Medical Innovations Inc. on 01/24/2005. The asset manufactures and markets pregnancy test kits and is based in Victoria, Australia.

Alere Inc. (NYSE:ALR) (United States)

Cambridge Diagnostics Ireland, Ltd.

Cambridge Diagnostics Ireland, Ltd. (CDIL) manufactures healthcare products. The company offers tests for the diagnosis of human immunodeficiency virus antibodies. In addition, it provides pregnancy and ovulation predictor tests. CDIL is based in Galway, Ireland. Cambridge Diagnostics Ireland, Ltd. is a subsidiary of Inverness Medical Innovations, Inc.

Alere Inc. (NYSE:ALR) (United States)

Inverness Medical Innovations, Inc., Consumer Pregnancy Test Product Assets

Inverness Medical Innovations, Inc., Consumer Pregnancy Test Product Assets comprises consumer pregnancy test assets. Inverness Medical Innovations, Inc. is based in Waltham, Massachusetts.

Alere Inc. (NYSE:ALR) (United States)

Visiomed Group SA (ENXTPA:ALVMG)

Visiomed Group SA engages in the development, creation, manufacture, and sale of healthcare medical devices. It primarily produces self-diagnosis products for medical use. The company offers thermometry products, including thermometer forehead and ear readings, infrared thermometers, and digital electronic thermometers; automatic blood pressure monitors; electrotherapy and phototherapy treatment devices for allergic rhinitis; and health and wellness products, such as electronic baby nose cleaners, multifunction nose trimmers, medical silicone orthse, and electronic anti-lice combs. It

42

http://www.prweb.com/releases/2012/7/prweb9714926.htm

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing

also provides diagnostic devices for diabetes, pregnancy, menopause, and ovulation tests; dental oral hygiene products comprising electronic toothbrushes and oral irrigators for traveling; body fat analyzers; weight measure scales; and impedance meters. The company offers its products primarily under the Alergo, Babydoo, Bell&Cross, Buccoster, Chuut, EasyTest, EasyScan, Nebulsol, Prosonic, TensioFlash, ThermoFlash, ThermoSoft, ThermoFluo, Ucare, Veinotens, WaterJet, and ZapX brands. Visiomed Group SA offers its products through wholesalers and distributors primarily in Europe, North America, and the Asia Pacific. The company was founded in 2006 and is headquartered in Paris, France.

Inverness Medical, LLC

Inverness Medical, LLC develops, manufactures, and markets consumer and professional medical diagnostic products. Its products include home test kits for pregnancy and ovulation prediction, nutritional supplements, and diabetes care supplies. The company offers its products to people with diabetes, and women's health and nutritional supplements markets. Its supplements are distributed through drug, food, and mass retailers, as well as in health food stores in the United States. The company was incorporated in 1997 and is based in Waltham, Massachusetts. Inverness Medical, LLC operates as a subsidiary of Alere Inc.

Alere Inc. (NYSE:ALR) (United States)

McNEIL-PPC, Inc., e.p.t Brand

As of March 1, 2011, e.p.t brand of McNEIL-PPC, Inc. was acquired by Insight Pharmaceuticals Corporation. e.p.t brand of McNEILPPC, Inc. provides home pregnancy testing services and is available through existing retail channels.

Insight Pharmaceuticals Corporation (United States)

SPD Swiss Precision Diagnostics GmbH

SPD Swiss Precision Diagnostics GmbH engages in the research, design, production, and supply of consumer diagnostic products for women. It offers digital pregnancy, fertility monitor, and digital ovulation tests. The company also provides PERSONA, a noninvasive solution of family planning to monitor hormone levels in urine. SPD Swiss Precision Diagnostics GmbH was founded in 2007 and is based in Petit-Lancy, Switzerland. The company has a research and development center in Bedford, the United Kingdom. SPD Swiss Precision Diagnostics GmbH operates as a joint venture between of Procter & Gamble Co. and Inverness Medical Innovations Inc.

Procter & Gamble Co. (NYSE:PG) (United States); Alere Inc. (NYSE:ALR) (United States)

b. HIV & INFECTIOUS DISEASE POC Infectious Disease Market POC infectious disease testing products can be used to screen for and diagnose a wide range of illnesses, including respiratory diseases such as influenza, common illnesses such as Strep A and H. pylori, HIV, hepatitis, tuberculosis (TB), sexually-transmitted infections (STIs) and tropical diseases such as malaria and dengue fever. Often, the tests can indicate if a disease may be present and follow-up lab tests may be required to confirm diagnosis.43 According to Espicom there are around 80 companies active in the POC infectious disease testing market, many of which are development-stage or have limited product portfolios and market share. The market leaders include Alere and Quidel for respiratory
Infectious Diseases Point of Care Diagnostics: Products Players and Outlook to 2017, Espicom Business Intelligence, February 2013
43

 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 15 disease diagnostics and for other POC tests commonly used in physicians offices.44 For HIV testing, market leaders include45: Alere with 2012 revenues of $2.4 billion Chembio Diagnostics with LTM revenues of $25.6 million OraSure Technologies with LTM revenues of $87.8 million Trinity Biotech with LTM revenues of $82.8 million As Espicom notes, Alere, with 2012 revenues of US$2.4 billion of which US$565 million were due to infectious disease tests, is clearly the market leader, providing tests across all major product sectors. Alere's success has been built, in part, due to an aggressive acquisition strategy.46 The market for POC infectious disease testing can be broadly divided into testing in the developed world, and testing in emerging and developing countries. In the developed world, POC testing is most frequently conducted in doctors offices and other professional healthcare settings, where it can potentially facilitate faster diagnosis and treatment than lab-based testing. Demand in the developed world varies significantly, with the US a strong adopter of the technology and Japan also frequently using POC influenza testing products. However, infectious disease testing in Europe continues to be predominantly conducted in central labs and the POC market in this region is under penetrated.47 According to Espicom Business Intelligence, Currently the market for POC infectious disease testing is worth over US$900 million and it is estimated to have grown by 20% between 2010 and 2011. As Espicom notes, Growth in the market is challenging to predict, given the fact that POC respiratory disease testing comprises a large portion of the market and growth in this area is largely dependent on the prevalence of respiratory disease in a given year. For example, the market rose rapidly in 2009 as a result of increased demand brought about by the pandemic H1N1 virus, declined in 2010 when there was a weak influenza season and rose again in 2011 when rates of influenza were higher. The market for POC infectious disease testing is expected to exceed $1.8 billion by 2017.48

Infectious Diseases Point of Care Diagnostics: Products Players and Outlook to 2017, Espicom Business Intelligence, February 2013 45 CapIQ Screening, Industry Classifications: Medical Testing, Analyzing, and Diagnostic Equipment OR HIV Test Kits OR Healthcare Distributors AND Company Status: Operating OR Operating Subsidiary OR Reorganizing AND Business Description > Keyword: Point-of-care OR Product Name > Keyword: pointof-care OR Product Description > Keyword: point-of-care AND Product Description > Keyword: HIV 46 Infectious Diseases Point of Care Diagnostics: Products Players and Outlook to 2017, Espicom Business Intelligence, February 2013 47 Ibid. 48 UT Library search: Point-of-care infectious disease

44

http://www.researchandmarkets.com/research/ggnknx/infectious

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing POC Infectious Disease Assays The following list highlights some of the POC assays for the infectious disease market. A more comprehensive list with additional details can be found in the attached spreadsheet. Prominent among these are OraQuick Advance which is a lateral flow assay that was approved by the FDA in 2003 and is estimated to hold approximately 62% of the rapid HIV test market in the U.S., Uni-Gold by Trinity Biotech which is a lateral flow assay that was approved by the FDA in 2003 and is estimated to hold approximately 13% of the market, and HIV Stat-Pak and Sure Check(Intl)/Complete(US) which are lateral flow assays that were approved by the FDA in 2006 and are estimated to hold 25% of the rapid HIV test market collectively.49 Also of significance is a move towards selling POC infectious disease products overthe-counter (OTC). In October 2012, OraSure launched the OraQuick In-Home HIV Test, the first rapid OTC HIV test to be approved by the FDA for use by consumers at home. As Espicom notes, The introduction of such products could present a significant growth opportunity for manufacturers.50 With regards to p24 assays, the Center for Innovation in Global Health and Technology (CIGHT) team at Northwestern University, led by director David Kelso, has developed the first point-of-care diagnostic for pediatric HIV designed to meet the needs of the limited resource settings of developing nations. According to CIGHT, The test consists of a low-cost dipstick p24 antigen assay with a visual readout format. Simple to perform and requiring minimal blood for testing, the revolutionary diagnostic gives results within 40 minutes, making it ideal for use in the developing world.51 The new CIGHT p24 assay was expected to reach the South African market in 2012, and was scheduled to be sold in other developing nations shortly thereafter. Abbott Laboratories Abbott RealTime HBV assay is used for measuring viral load or the amount of hepatitis B virus (HBV) in a patients blood. The test offers sensitive measurement (quantitation) of HBV in human plasma or serum from individuals chronically infected with HBV. The assay is intended for use as an aid in the management of patients with chronic HBV infection undergoing anti-viral therapy. The assay can be used to measure HBV DNA levels at baseline and during treatment to aid in assessing response to treatment. Alere Inc. Acceava is a womens health product and Infectious Disease Diagnostic Product.

Chembio Diagnostics, Inc. Investor Presentation, June 2012, Retrieved from: http://edg1.precisionir.com/companyspotlight/NA015984/062012CEMIInvestorPresentation.pdf 50 Infectious Diseases Point of Care Diagnostics: Products Players and Outlook to 2017, Espicom Business Intelligence, February 2013 51 CIGHT Develops New Rapid Infant HIV Diagnostic, Center for Innovation in Global Health Technologies - CIGHT - Northwestern University, 2011, Retrieved from: http://www.cight.northwestern.edu/news/20110704news.html

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 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 17 The Alere CD4 Analyzer is the first point-of-care platform which measures absolute CD4 counts in HIV patients with results in 20 minutes, using single-use, disposable fingerstick cartridges. Alere Determine is an Infectious Disease Diagnostic Product. bioLytical Laboratories Inc. INSTI(TM), a 60-second rapid HIV test for point-of-care testing. The acceptance clears the way for BioLytical to immediately begin its US clinical trials. The acceptance of IDE application for INSTI(TM) is an important first step in providing US residents unparalleled access to a very quick and highly accurate HIV test, says Richard Galli, Chief Technical Officer of BioLytical. Both patients and healthcare providers will benefit from the simple format which boasts superior accessibility and ease of use compared to traditional testing methods. Chembio Diagnostics, Inc. Chembio DPP HCV Finger-stick Blood and Oral Fluid Tests: The rapid assays evaluated were single use, disposable, in vitro, qualitative, immuno-chromatographic assays to detect anti-HCV with visual results in less than 40 minutes. Behavioral risk assessment surveys and testing for HCV were conducted among persons who reported injection drug use (IDU) within the past 6 months as part of the Study to Assess Hepatitis C Risk (STAHR) among people who inject drugs (PWID) aged 18-40 years in 2009-2010. Chembio HIV 1/2 STAT PAK is called as Clearview HIV 1/2 STAT-PAK in the United States only. Chembio Sure Check HIV 1/2 now also known as Inverness/Clearview Complete HIV 1/2. Grant Life Sciences, Inc. AIDS test device consists of a blood sample pad containing HIV-antigen gold conjugate, a capillary membrane with three capture lines for HIV-1, HIV-2 and a control line, and a fluid absorption pad. When test strips are placed in the tube containing the test serum or plasma, the liquid migrates upwardly by capillary action. OraSure Technologies Inc. The OraQuick In-Home HIV Test is it the first and only oral fluid rapid over-thecounter (OTC) HIV test approved in the U.S. It can detect antibodies to both HIV1 and HIV-2 with an oral swab, providing a confidential in-home testing option with results in as little as 20 minutes. The OraQuick ADVANCE Rapid HIV-1/2 Antibody Test is FDA-approved for use with oral fluid, fingerstick or venous whole blood and plasma and delivers results with laboratory accuracy in 20 minutes. CDC guidelines call for routine testing in all healthcare settings to identify all HIV positive people and connect them to care. This simple test is ideal for screening programs in public health and outreach settings, emergency departments, labor and delivery, laboratories and physician offices.

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing OraQuick HCV Rapid Antibody Test The first and only FDA-approved, CLIAwaived and CE-marked approved point of care test for HCV. Our simple platform enables healthcare providers to deliver an accurate diagnosis in 20 minutes. OraSure QuickFlu Rapid Flu A+B Test is an FDA approved in vitro rapid qualitative test for the detection and differentiation of influenza type A and type B. An easy nasal swab procedure provides accurate results in as little as 10 minutes. OraSure HIV-1 Oral Specimen Collection Device collects oral fluid, which contains antibodies. The simple 2-5 minute collection procedure is ideal for insurance testing and other non-medical settings. The OraSure device is placed into a preservative and shipped to a lab where the sample will be screened for HIV-1 antibodies. OraSure HIV-1 Western Blot Kit is a confirmatory assay for the detection of antibodies to individual proteins of HIV-1 in oral fluid specimens obtained with the OraSure HIV-1 Oral Specimen Collection Device. QuantRX Biomedical Corporation The PADKit integrates the miniform technology with the diagnostic expertise. The PADKit contains a miniform used as a collection device to collect a sample for diagnostic evaluation. The PADKit is designed to provide the preferred sample collection system population scale testing for indications such as HPV, Human Immunodeficiency Virus (HIV), and general health screening, where healthcare professionals are not readily accessible. Quest Diagnostics Inc. AccuType IL28B test is used for aiding in the prediction of patient response to peginterferon alpha-based therapy for hepatitis C virus, or HCV, infection. Alpha-Fetoprotein (AFP) and Glypican-3 tests are used to determine risk, diagnosis and prognosis of hepatocellular carcinoma (HCC). HCC is the fifth most common cancer in the world, and patients most at risk for this liver-based malignancy are those with chronic hepatitis B or C virus infections and those with hepatic cirrhosis. StatSure Diagnostic Systems, Inc. Hema-Strip HIV is a single use test kit that collects, processes and analyzes a minute amount of whole blood (2.5 micro liters), plasma, or serum sample to detect HIV antibodies. Sample collection requires only a few seconds. The whole blood sampling technology used in Hema-Strip is identical to that utilized in Sero-Strip; however, an added filter traps red blood cells from the whole blood sample permitting the migration of serum to flow onto the strip and negating the need for the user to centrifuge a specimen to separate serum from the whole blood sample. Saliva-Strip HIV collects, processes and analyzes saliva to detect HIV antibodies. The test is currently designed for single use, incorporates the Saliva-

 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 19 Sampler or Omni-SAL device, and is based on the saliva collection technology. Sero-Strip HIV analyzes a small amount of serum or plasma to detect HIV antibodies. Sero-Strip is packaged as a multiple-use kit designed for professional health care settings where patients are tested typically undergoing a venipuncture to obtain sufficient plasma or serum for several tests, and where specimens may be stored and tested in a batch run. Stat-Simple H.pylori (Stat-Simple) is the rapid assay for H.pylori antibody detection. The device is based on the patented whole blood sampling technology and licensed test components. The test uses a minute sample of whole blood (2.5 micro liters) from a finger-stick for analysis. Results are available at pointof-care (e.g. doctors office) without the need for sophisticated equipment. Thermal Gradient Inc. Flash Remote is Thermal Gradient's most ambitions product development effort. Supported by NIH funding, Thermal Gradient is developing a "field deployable" system that will bring HIV testing to "resource limited settings" such as subSaharan Africa. This system will enable testing for diagnosis and on-going viral load monitoring within 30 minutes of access to the patient. The heart of this system is the Flash Cartridge; a complete, disposable sample-to-answer test device, combining nucleic acid extraction and purification with quantitative PCR amplification. Trinity Biotech plc The Trinity Biotech Uni-GoldTM HIV test is a single reagent assay for the detection of antibodies to human immunodeficiency virus types 1 and 2 in serum, plasma or whole blood. Recombinant proteins representing the immunodominant regions of the envelope proteins of HIV-1 and HIV-2, glycoprotein gp41, gp120 (HIV-1) and glycoprotein gp36 (HIV-2) respectively are immobilised at the test region of the nitrocellulose strip. These proteins are also linked to colloidal gold and impregnated below the test region of the device. A narrow band of the nitrocellulose membrane is also sensitised as a control region.52 MedMira Inc. MedMira rapid double antigen serological test platform has been developed using two unique recombinant HIV antigens. The more specific HIV antigen (HIVa) is conjugated to a color marker. This conjugated HIVa antigen complex is then incubated with any human specimen such as blood, urine or saliva. During the short incubation (2-3 minutes) the specific antibodies present in the specimen form an immunological complex which is then allowed to react further with the second HIV antigen (HIVb) which has been immobilized on the biosupport. MedMira Rapid HIV Tests:

Trinity Biotech Uni-Gold HIV, http://www.trinitybiotech.com/Product%20Documents/120650229%20EN.pdf

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing HIV testing a series of complimentary rapid tests based on the same technology platform have been developed for hepatitis and the simultaneous detection of HIV and hepatitis. Roche Diagnostics, Ltd Cobas TaqScreen MPX Test for use on the cobas s 201 system, is a qualitative, in-vitro test for the simultaneous, direct detection of the human immunodeficiency virus (HIV-1 Group M RNA, HIV-1 Group O RNA, HIV-2 RNA), hepatitis C virus RNA and hepatitis B virus DNA in human plasma. The test was approved in the US last year for screening plasma specimens from blood donors and, earlier this year, received the CE Mark for screening source plasma. Early Infant Diagnosis (EID) of HIV Related to infectious disease POC diagnostics, early diagnosis of HIV infection is critical in order to ensure optimal treatment outcomes for children. Children who are born to mothers with HIV have been exposed to HIV but may not necessarily be HIV-positive. WHOs 2010 guidelines on antiretroviral therapy for HIV infection among infants and children recommended that HIV-exposed infants be tested by four to six weeks of age using polymerase chain reaction (PCR). According to the World Health Organization, It is to be expected that, for the foreseeable future, at least 500,000 HIV-infected infants will be born each year, most of them in low-income countries with generalized epidemics. Mother-to-child transmission of HIV accounts for the vast majority of the 2.3 million children under the age of 15 years who are estimated to be living with HIV (1.73.5 million) , almost 90% of them in sub-Saharan Africa.53 Significant progress has been in early infant diagnosis of HIV. As WHO notes, 65 lowand middle-income countries providing data (up from 54 countries in 2009), 28% [24 30%] of infants were reported to have been tested for HIV within the first two months of birth, versus 6% [57%] in 2009. This increase results in part from including data in 2010 from nine priority countries for eliminating mother-to-child transmission that did not report on this indicator in 2009.54 The following table outlines some of the reported and projected numbers for women living with HIV who are delivering, the number of new pediatric HIV infections, the mother-to-child HIV transmission rate, as well as other related indicators and metrics for low- to middle-income countries.55
Early Detection of HIV in Infants and Children, World Health Organization, http://www.who.int/hiv/paediatric/EarlydiagnostictestingforHIVVer_Final_May07.pdf 54 Ibid. 55 Ibid.
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 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 21

Figure 2 - World Health Organization Global HIV/AIDS Response: Epidemic update and health sector progress towards Universal Access Progress Report 2011

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing The following table shows the estimated percentage of women who received HIV testing for the years 2005, 2008, 2009, and 2010 in low- and middle-income countries according to region.56

Figure 3 - World Health Organization Global HIV/AIDS Response: Epidemic update and health sector progress towards Universal Access Progress Report 2011

CONCLUSIONS AND RECOMMENDATIONS Based on the information that was collected about each market, we believe that Evik Diagnostics would be better served placing their funding into the pregnancy and fertility segment of the POC testing market. While there are relatively few rapid HIV and infectious disease tests on the market, and even fewer p24 assays for early infant diagnosis of HIV, the demand for these tests is not as high in developed nations as it is in developing countries and regions. While the market for HIV and infectious disease testing is under-penetrated in developing nations, financial support for this market is limited to non-profit and government funding. Although the full pregnancy and fertility market size is difficult to measure, we have reason to believe that this market segment is larger and more robust than the HIV and infectious disease segment. There is also a significantly greater number of potential customers and opportunities for distribution and growth within the market, both nationally and internationally. Additionally, the IBISWorld report posits the following: Over the five years to 2017, the industry will benefit from slowly improving economic conditions, which will result in an increase in the birth rate as couples who waited out the recession will start planning families. This will translate into

Global HIV/AIDS Response: Epidemic update and health sector progress towards Universal Access Progress Report 2011, World Health Organization, 2011, Retrieved from: http://whqlibdoc.who.int/publications/2011/9789241502986_eng.pdf

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 Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing 23 greater demand for pregnancy tests and other family planning products, benefiting industry revenue growth during the five-year period.57 As a result, we believe Evik Diagnostics should pursue product development for diagnostic equipment in this segment of the POC market.

SOURCES AND ADDITIONAL RESOURCES a. Websites acaciofertility.com alere.com azblue.com azfertility.com bannerhealth.com bd.com biolytical.com businessweek.com capbluecross.com care-plus-health-plans.com cdc.gov census.gov chembio.com cight.northwestern.edu fertilitylifelines.com grantlifesciences.com omegadiagnostics.com orasure.com quantrx.com questdiagnostics.com rightdiagnosis.com roche.com slideshare.net statsurediagnostics.com thermalgradient.com tributepharma.com trinitybiotech.com vmware.com who.int worldbank.org

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http://www.prweb.com/releases/2012/7/prweb9714926.htm

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Point-of-Care (POC) Diagnostics Market: Pregnancy and Infectious Disease Testing b. Magazines and Additional Resources Fertility Today (http://www.fertilitytoday.org) Conceive (http://www.conceiveonline.com/) Fertility Community (http://www.fertilitycommunity.com/fertility/resources.html) c. Databases Business Source Complete (UTexas Libraries; available at the Austin Public Library) Business & Company Resource Center (UTexas Libraries; available at the Austin Public Library) CapIQ (Available only with subscription) Factiva (UTexas Libraries; available at the Austin Public Library) JSTOR (UTexas Libraries; available at the Austin Public Library) Web Science (UTexas Libraries) d. People Vitae Clinic (Austin, Texas)