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Binx Health Obtains FDA 510 (K) Approval for Rapid Process Platform for Women's Health



Boston, September 5, 2016 / PRNewswire / – binx health, a pioneer in women's health testing that can be done anytime, anywhere, announces that the company has received 510 (k) approval from the US Food and Drug Administration to complete its new, high-quality Sensitive and Specific platform. for molecular care diagnostic tests (POC) called binx IO® To the market. The binks AND ABOUT.The platform is a fast and fully automated test designed for ease of use and designed for use in medical facilities or in clinical laboratory conditions, and this is the first instant in the world in 30 minutes. Chlamydia (CT) and Gonnorhö (gonorrhea or NG) are the most common sexually transmitted diseases in the world. In a clinical study recently conducted by a company in several sites, 96% of non-laboratory samples were in POC through binx. AND ABOUT. are being processed.

binx io provides the very first “testing and treatment” paradigm, with results for the two most commonly tested STIs in 30 minutes

The Centers for Disease Control (CDC), the US Preventive Services Task Force (USPSTF), and the American College of Obstetricians and Gynecologists (ACOG) recommend annual testing for chlamydia and gonorrhea for millions of women in the United States. The current standard of care in the field of CT / NG testing includes a long waiting time from taking a sample to obtaining a result (often up to 7 days), with up to 40% of 1 positive patient not returning to treatment after treatment left the doctor’s office.

“Today, we have announced an important milestone in the effort to make STD testing with a platform profile and performance level quick and convenient, as well as the potential to significantly improve the health outcomes of millions of women in the United States,” said Jeff Lueber, President and CEO of Binx Health . As the “focus” on healthcare shifts toward conditions close to the patient, today's FDA approval will move strong and quick care in the place where consumers need it most – the communities where they live, work and shop. "

STDs have risen sharply and represent a growing international public health crisis. The World Health Organization (WHO) estimates that more than one million STDs are transmitted per day2, and WHO has commented on the growth of STDs as a “hidden, quiet and dangerous epidemic.” and stated that increasing the level of infection for the authorities should be a “wake-up call" “so that everyone has access to services for the prevention and treatment of sexually transmitted diseases”. In the United States, the CDC reported that only 12% of 3 people between the ages of 15 and 25 who were planning to have an annual test were tested for sexually transmitted diseases, although they accounted for 50% of the annual burden of infection. In women, unexplained sexually transmitted diseases can lead to reproductive health problems and so on. but. Infertility, pelvic infections, ectopic pregnancy and other related diseases that can often be prevented by early detection in conditions close to the patient.

PLATFORM DETAILS

In the binx AND ABOUT. It is a stable and easy-to-use diagnostic platform that can handle up to 24 targets at the same time and does not require calibration or maintenance. The platform consists of a small benchtop tool and a disposable cartridge for a specific sample, which can process an untreated patient sample without user intervention when it is inserted into the cartridge. The cartridge contains all the reagents needed for the analysis and has a PCR amplification method and binx's own electrochemical analysis technology to ensure fast and accurate results. AND ABOUT. approved for use both in medical institutions and in clinical laboratories, for the detection of chlamydia and gonorrhea in samples of vaginal smears taken by a doctor or the patient herself in a clinical setting.

Banks AND ABOUT.The platform is elegantly designed and highly recognizable, ”said Dr. Anna Dixon, CTO. “After we have been certified for CT / NG and after this strong predicate has been introduced, we look forward to submit our further strong sexual health checks for approval.”

RESULTS OF CLINICAL STUDIES

A recent clinical study in several places, involving more than 1,500 patients with and without symptoms, showed that AND ABOUT. Compared to existing central laboratory systems in nursing homes as an accurate and reliable platform for testing for chlamydia and gonorrhea, two of the most common STDs in women. The results of a clinical study showed 96.1% sensitivity and 99.1% specificity for chlamydia and 100% sensitivity and 99.9% specificity for gonorrhea in the examined women.

"Our experience in testing binx AND ABOUT.“Systems have revealed a potentially important paradigm shift in the approach to STDs,” says Dr. Barbara Van Der Paul, president of the American STD Association and head of the diagnostic lab at the University of Alabama at the Birmingham School of Medicine. We found that most patients are willing to wait if they are promised fast results, which means testing and treatment are possible on the same day. ”

CLINICAL RECOMMENDATIONS

CDC, USPSTF, and ACOG recommend annual screening for chlamydia and gonorrhea for sexually active women under the age of 25, for all pregnant women under the age of 24, and for older women at higher risk of infection. 5,6,7 CDC also recommends repeating the test within three months after treatment8. ACOG and CDC also recommend conducting Chlamydia gonnorho Nucleic Acid Amplification Test (NAAT) on vaginal smears, which is the technical approach and type of sample that binx is used for AND ABOUT. approved by the U.S. Food and Drug Administration

HEALTH INFORMATION BINX Binx Health (TM)

is a pioneer in the field of women's health testing, which can be done anytime, anywhere, where they live, work and shop. We achieve this by developing (1) our own fast desktop PCR tools for pharmacy retailers, ambulances, primary care, medical centers and other inpatient facilities where tests and quick results are in place and on demand at the testing level Central laboratories are crucial and (2) mobile medical test solutions that are conducted at home, giving consumers an “instant guarantee”. Starting with STDs, our goal is to reverse the trend of rising infections among young people and improve family health by expanding our offer of home and home services. The binx health investors are financial investors Johnson & Johnson Innovation, Novartis venture capital fund, LSP, BB Biotech, venture partners RMI Investments and Technology and strategic investors Consort Medical (which owns the company's cost-effective and patented multiplex cartridges) Wondfo Biotech, a Chinese company.

1 Huang W, Gaydos CA et al. (2012). Comparative effectiveness of the rapid test at the place of medical care for the detection of Chlamydia trachomatis in women in a clinical setting. STI. 88. First published online on September 14, 2012. Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3 671871 /

2 https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)

3 https: //www.jahonline.o rg / article / S1054-139X (16) 00019-7 / full text

4 Huang W, Gaydos CA et al. (2012). Comparative effectiveness of the rapid test at the place of medical care for the detection of Chlamydia trachomatis in women in a clinical setting. STI. 88. The first online release September 14, 2012. Https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3 671871 /

5 Final recommendation: chlamydia and gonorrhea: screening. USA Preventive Services Task Force. May 2019

https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/chlamydia-and-gonorrhea-screening

6 Final recommendation: chlamydia and gonorrhea: screening. USA Preventive Services Task Force. May 2019

https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/chlamydia-and-gonorrhea-screening

7 Keegan M.B., Didrich J.T., Pipert J.F. Chlamydia trachomatis infection: Screening and management. J Clin Outcomes Manag. 2014; 21 (1): 30-38.

8 Final recommendation: chlamydia and gonorrhea: screening. USA Preventive Services Task Force. May 2019 https://www.uspreventiveservicestaskforce.org/Page/Document/RecommendationStatementFinal/chlamydia-and-gonorrhea-screening

9 Keegan M.B., Didrich J.T., Pipert J.F. Chlamydia trachomatis infection: Screening and management. J Clin Outcomes Manag. 2014; 21 (1): 30-38.

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Inquiries and contacts:

Press Contact: Tony Labriola
(978) 815-8640
fashionable@thinkinsideout.com

Contact for investors
Mark jones
(603) 566-5353
marc.jones@mybinxhealth.com


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