binx health

A self-motivated individual is required as this role will involve working with others to support and develop effective business processes across internal departments. The successful applicant will be able to demonstrate the ability to support the implementation and maintenance of an integrated electronic QMS that meets the requirements of ISO13485:2016 / 21 CFR Part 820 whilst maintaining effective business processes. Provide QA team resource for the day to day administrative requirements of the quality management system, including but not limited to CAPA, document control and record keeping. A minimum of 2 years’ hands-on experience in an IVD or medical device setting An understanding of the role of quality in a business context

binx offers first FDA 510(k) cleared molecular point-of-care solution for test and treat of sexually-transmitted infections in a single visit binx health today announced the launch of its pre-order program for the world’s first FDA-cleared, rapid molecular point-of-care instrument, which provides diagnosis in about 30 minutes to enable single visit test and treatment for chlamydia (CT) and gonorrhea (NG) in women. Our recent UK pilot, launched following our receipt of CE Mark in 2019, has resulted in hundreds of male and female patients being tested for CT and NG and, for the first time, positive patients are now leaving with prescription in hand, rather than waiting up to twenty-one days for a result, as can be typical in some of these settings,” said Anna Dixon, the company’s Chief Technology Officer. binx received its CE Mark for CT/NG in male urine and female vaginal swab samples in April 2019 and its FDA 510(k) clearance for CT/NG in female vaginal swab samples in August 2019. The binx health io CT/NG Assay, when tested using the binx health io Instrument, is a fully automated, qualitative test intended for use in point-of-care or clinical laboratory settings for the rapid detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA in female vaginal swab specimens collected either by a clinician or self-collected by a patient in a clinical setting.

The 2.4 million cases reported in 2018 mark sustained national rising STD rates (also commonly referred to as sexually transmitted infections or STIs). A 36% increase in syphilis among young people who can become pregnant drove this rise in congenital syphilis. The CDC recommends annual chlamydia screening for all sexually-active women younger than 25 years old and older women with new or multiple sex partners. And yet, over half of sexually-active women aged 16–24 years are not receiving chlamydia screening, leaving them vulnerable to the consequences of undetected infection.

The presentation will be webcast live and may be accessed by visiting https://wsw.com/webcast/canaccord37/binx/. ABOUT BINX HEALTH binx health is the pioneer in anywhere care in women’s health for consumers where they live, work and shop. With the first FDA 510(k) cleared solution for the rapid testing of Chlamydia (CT) and Gonorrhea (NG) in women, binx is poised to transform care for the two most tested for sexually-transmitted infections globally. Today, 40% of patients who test positive for CT/NG do not come back for treatment once they leave a physician’s office—making the need for rapid test and treat solutions paramount. ’s investors include financial investors Johnson & Johnson Innovation, Novartis Venture Fund, LSP, BB Biotech, RMI Investments and Technology Venture Partners and strategic investors Consort Medical (whose wholly owned subsidiary