binx health Receives CE Mark for Rapid Chlamydia and Gonorrhea Test for Mass Markets

Multiplex Test Panel for binx io® Point-of-Care Platform
Positioned to Radically Reduce Time to Treatment, Expand Access to Care

May 1, 2019 (BOSTON, MA) –  binx health, the pioneer in anywhere care today announced that its proprietary Chlamydia and Gonorrhea (CT/NG) test has received European CE Mark approval. The new multiplex test works with the binx io platform, delivering a laboratory-quality result in about 30 minutes, creating a new model for “test-and-treat” care for two of the most prevalent Sexually Transmitted Infections (STIs) globally.

More than one million STIs are acquired worldwide every day with chlamydia and gonorrhea representing two of the most prevalent[1].  Recent data released by the European Centre for Disease Prevention and Control (ECDC) notes a striking rise in the cases of gonorrhea – up 17% between 2016 and 2017 across the reporting EU/EEA countries, with some countries noting year-over-year spikes of more than 40%[2].  Similarly, in the United States, infection rates have risen an astonishing 67% since 2013, with rates continuing to be highest in the 20-24 year-old age group.[3]

Today, the majority of CT/NG tests are sent to central laboratories, meaning there can be up to a seven day waiting period from first visit to treatment, during which time patients may continue to spread infection, with up to 40% of positive patients never returning for treatment[4]. binx is positioned to radically change this paradigm, enabling patients and consumers to leave a retail pharmacy, primary care office, clinic, urgent care facility and any other brick-and-mortar location, with treatment in hand in a single visit (while the binx point-of-care platform is not yet available in the United States, the company recently completed its multi-center clinical study for submission to FDA for 510(k) clearance). The binx io platform is designed for ease-of-use, enabling non-laboratory-trained users to run a test with the same accuracy as a central lab test, making it ideal for use in a variety of approved medical and consumer settings.

“Achieving a 30-minute diagnostic turnaround time for two of the most common STIs is a major public health breakthrough,” explains Howard Heller, MD MPH, binx health’s Chief Medical Officer. “Rapid results equal rapid, appropriate treatment.  This new panel enables a path to not just same day, but same visit testing and treatment, eliminating an immense barrier to care and cure.”

“Modern healthcare delivery requires tools that meet consumers’ needs where they live, work and shop,” said Jeffrey Luber, binx health’s Chief Executive Officer. “Doing this effectively means delivering fast, accurate, cost-effective solutions at brick-and-mortar locations, as well as physician-ordered, medical guideline-based testing online, that work to bring consumers from ‘worry to well’ in the locations most convenient for them. Through scientific rigor, guideline-based testing, and an ‘anywhere’ mindset that puts the consumer at the center of all we do, today we embark on a path to deliver omnichannel, high quality care in family health, starting with young people and STIs as our launching point.”

About binx health 

binx health is the pioneer in anywhere care for consumers where they live, work and shop. We do this with (1) proprietary, rapid desktop PCR instruments for retail pharmacy, urgent care, primary care, health centers, and any other brick-and-mortar location where onsite, on demand testing and rapid results on par with central lab testing, are paramount, and (2) mobile solutions for at-home, physician-ordered testing that aim to bring consumers from “worry-to-well” in the palm of their hands. Starting with sexually-transmitted infections, we aim to reverse trends of rising infections among young people, and move into broader family health through the expansion of our point-of-care and at home offerings. binx health’s investors include financial investors, Johnson & Johnson Innovation, Novartis Venture Fund, LSP Venture Capital, BB Biotech, RMI Investments and Technology Venture Partners and strategic investors, Consort Medical (whose wholly owned subsidiary Bespak are the makers of the company’s low-cost, proprietary multi-plex cartridges) and China-based Wondfo Biotech.

[1] WHO Key facts 28 Feb 2019

[2] EDCD EUROPE

[3] Division of STD Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention

[4] Gift, Thomas L. et al. Sex Tran Dis: April 1999 – Volume 26 – Issue 4 – p 232–240