FDA Allows Use Of Binx Health’s Test To Detect STI At Point-of-care Settings
The U.S. Food and Drug Administration or FDA has allowed the use of Binx Health IO CT/NG Assay at point-of-care settings for the detection of Chlamydia (CT) and gonorrhoea (NG) – the two most tested-for sexually transmitted infections.
This action is the result of the FDA granting a waiver under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) for the Binx Health IO CT/NG Assay. The assay was granted market clearance by the FDA in August 2019.
The test can now be conducted at more near-patient care settings such as in physician offices, community-based clinics, urgent care settings, outpatient health care facilities and other patient care settings, operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.
The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, which is a major milestone in helping patients.
The test, which uses female vaginal swabs and male urine specimens, can detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually transmitted infections chlamydia and gonorrhea, respectively. The test provides actionable results in about 30 minutes.
The test’s performance was evaluated in females 16 years and older and in males 17 years and older and was demonstrated to be comparable to tests performed in a CLIA certified laboratory.
This is claimed to be the first ever 30-minute, CLIA-waived, molecular point-of-care (POC) PCR Test for CT/NG now available for point-of-care settings.
The CLIA waived status also allows for expansion by permitting the binx io, through its national commercial distribution partnership with McKesson, to be placed in the over 220,000 CLIA-waived locations across the U.S.
According to the CDC, one in five Americans are diagnosed with sexually transmitted infections every year. There are an estimated 108 million people in the U.S., for whom regular STI testing is appropriate.
The standard of care today for Chlamydia and gonorrhea testing typically involves long wait times from sample to result (often up to seven-day turnaround times), with up to 40% of positive patients not returning for treatment once they leave a physician’s office, according to privately-held Binx Health.
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