New placement program for the binx io, the first and only male/female FDA-cleared, CLIA-waived point-of-care instrument for chlamydia (CT) and gonorrhea (NG), offers CLIA-waived facilities the opportunity to deliver critical CT/NG results in about 30 minutes versus days through centralized lab testing
BOSTON, November 1, 2022 – binx health, a healthcare technology and women’s health company focused on making routine testing broadly accessible and convenient, announced today the launch of its instrument placement program for CLIA-waived facilities. This program eliminates all upfront instrument costs, enabling access to rapid testing and helping pave the way to better health outcomes. CT and NG are two of the most tested for sexually transmitted infections (STIs). With millions of CT/NG tests processed at central laboratories annually, and 230,000 CLIA-waived sites across the United States, the binx io can be a catalyst for transforming how and where STI’s are diagnosed and treated. The company has begun accepting pre-orders under its “early access” program for Q1 deliveries.
Routine testing for CT and NG is recommended by the Centers for Disease Control and Prevention (CDC) for all women ages 15-24, including at-risk pregnant women, with testing also recommended for other individuals at higher risk for STIs. With a rapid ~30-minute turnaround time, laboratory quality performance, and more rapid treatment, the binx io can play a key role in helping to reduce onward transmission and infection spread.
“Providing the binx io CT/NG offering directly to clinics under this cost-effective model brings us closer to our mission of making healthcare easier and more accessible for patients,” said Jeffrey Luber, Chief Executive Officer of binx health. “Whether through our point-of-care or at-home offerings, our mission is to expand access to critical healthcare offerings and to arm OB-GYNS and healthcare providers broadly with the tools they need to reach patients everywhere. Today’s announcement reflects our commitment to removing barriers and accelerate the proliferation of point-of-care testing. We will continue to partner with those on the front lines of care and leaders in women’s health, as well as the nation’s largest enterprises with a commitment to sexual health and wellness for so many.”
Further increasing accessibility and ease-of-use, the binx io can also interface with electronic medical records (EMR) systems, laboratory information systems (LIS), and middleware applications to offer seamless data transmission; all of which are essential to broad adoption.
Please contact binx today to participate in the early access program and reserve a binx io at email@example.com or visit www.binx-io.com. Units ordered through the reagent rental program will begin shipping in early Q1 2023.
The binx io system is a molecular point-of-care diagnostic testing platform, the first and only FDA 510(k) cleared and CLIA-waived test for chlamydia and gonorrhea that provides a result in about 30 minutes for both men and women, enabling single-visit diagnoses and treatment. Combining ultra-rapid PCR along with our proprietary electrochemical detection technology, the binx io system can deliver sensitivity and specificity equivalent to laboratory quality performance at the point of care.5
Intended Use The binx io CT/NG Assay, when tested using the binx io Instrument, is a fully automated, rapid, qualitative test intended for use in point-of-care or clinical laboratory settings for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae DNA by polymerase chain reaction. The binx io CT/NG Assay is intended for use with female vaginal swab specimens, collected either by a clinician or self-collected by a patient in a clinical setting, or male urine specimens, as an aid in the diagnosis of symptomatic or asymptomatic Chlamydia trachomatis and/or Neisseria gonorrhoeae infection. For a symptomatic male patient with a chlamydia negative test result, further testing with a laboratory-based molecular test is recommended.
binx is a healthcare technology and women’s healthcare company that is leading the way to accessible routine testing by partnering with primary care, public health, retail health, universities, and leaders in HIV prevention and sexual health to reach underserved populations and impede the spread of sexually transmitted infections. The Company’s omnichannel platform is the only healthcare delivery model designed to reach people in-clinic and at-home with novel access modalities focused on the patient. binx is paving the way to improve population health issues at scale in partnership with those on the front lines of care. The Company’s dual-care offerings include the binx io, the first ever FDA-cleared, CLIA-waived, point-of-care chlamydia and gonorrhea test for males and females providing central lab performance results in about thirty minutes, and binx everywhere, a physician-mediated, secure, and highly configurable technology platform that integrates self-collection with high-quality laboratory testing and follow-up. binx’s proprietary platforms enable organizations to broaden access to care, promote health equity, and connect all key stakeholders of healthcare delivery in a seamless, evidenced-based manner that engenders consumer delight.
For more information, visit www.binx.com.
1https://www.cdc.gov/std/chlamydia/stdfact-chlamydia-detailed.htm 2Health Advances, Benchmarking of Performance Requirements and Outlook for io. 3https://www.cms.gov/regulations-and-guidance/legislation/clia https://www.aacc.org/advocacy-and-outreach/position-statements/2021/modernization-of-clia-certificate-of-waiver#:~:text=Since%201993%2C%20the%20number%20of,an%20increase%20of%20259%20percent. 4Workowsk KA et al. Sexually Transmitted Infection Treatment Guidelines. MMWR Recomm Rep 2021;70(4):1-187 5Van Der Pol, B. et al. Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea. JAMA Network Open 3(5) (2020): e204819
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