BD, Visby Medical snag updated FDA nods for women's health PCR tests

The FDA cleared a pair of tests this week both aimed specifically at improving diagnoses of women’s health conditions.

The tests came from BD and Visby Medical. Both are fast-turnaround PCR tests, and both represent upgraded versions of diagnostics that had previously earned the regulatory agency’s nod.

BD’s offering is designed to detect the three most common infections associated with vaginitis: vulvovaginal candidiasis, Trichomonas vaginalis and bacterial vaginosis, the last of which can increase an individual’s chances of contracting a sexually transmitted infection (STI). Though it tests for organisms associated with all three infections at the same time, from just one sample swab, the assay returns separate positive or negative results for each.

The BD Vaginal Panel was originally cleared by the FDA in 2016 for use on the medtech giant’s BD Max automated PCR platform, which can perform up to 24 tests at once and return their results within three hours. The newly cleared version, meanwhile, has been reworked to run on the BD Cor molecular diagnostics analyzer, which can take in 1,700 samples at once and churns out their results throughout a 24-hour period. It’s now the third test given the green light to run on the BD Cor platform.

Additionally, the single sample used to run the BD Vaginal Panel can simultaneously be used in the BD CTGCTV2 test—the second assay cleared for use on BD Cor analyzers—which detects the bacteria behind three of the most common non-viral STIs: chlamydia, gonorrhea and trichomoniasis.

In its announcement about the updated clearance this week, BD noted that its three-in-one test could not only reduce the need for repeated testing but also help reduce an individual’s risk of contracting an STI and cut down on unnecessary or ineffective treatments—especially for yeast infections, because the test is able to distinguish between separate bacteria that are linked to the infection and that may be resistant to certain antimicrobial treatments.

“Most women have a vaginal infection during their lifetime, and millions of them receive inadequate treatment,” said Nikos Pavlidis, vice president of BD’s diagnostics business. “A recent study showed that four out of 10 women didn’t receive the appropriate diagnosis and treatment for their vaginitis symptoms after an initial physician visit, which led to four out of 10 women having to schedule a new appointment because of persistent symptoms.”

Visby’s green light, meanwhile, came for a point-of-care diagnostic rather than a lab test like BD’s. The women-specific sexual health test looks for signs of Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis, the same STI-causing bacteria detected by BD’s CTGCTV2 test.

Visby’s hand-held analyzer is able to return results in just 30 minutes, after a clinician plugs in the machine, inserts a patient-collected sample and flips a switch. Like BD’s vaginitis test, Visby’s produces separate results for each of the possible bacteria.

The test was first cleared in August 2021. According to its maker, the second-generation version simplifies the testing machine: While its original hand-held analyzer required clinicians to slide the sample door closed and push three buttons to start the test, the new and improved iteration features just a single switch that simultaneously covers the sample and activates the machine.

“Providing more customers with access to the Visby platform will enable clinicians to make informed treatment decisions during the span of a single clinic visit,” Gary Schoolnik, M.D., Visby’s chief medical officer, said in an announcement this week, adding that the improved care could in turn help cut down on both overtreatment and undertreatment and slow the spread of STIs.

With the new FDA clearance, Visby will begin rolling out the tests on a broader scale via its fully automated production lines, according to Mark Medlen, the company’s senior VP of operations.