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PCR is a mainstay in diagnostics, but whether a sample is collected at a clinic or at home, such tests require sending a sample to a lab and then waiting for results. A new FDA authorized over-the-counter test from Visby Medical essentially puts the lab in the user’s hand.
The FDA on Friday granted marketing authorization to the Visby Medical Women’s Sexual Health Test, a diagnostic for three sexually transmitted infections (STIs): chlamydia, gonorrhea, and trichomoniasis. The FDA said the Visby product is the first diagnostic that can be purchased without a prescription and performed entirely at home to test for these three pathogens.
Home-based STI tests are already available, but they’re test collection kits that still require users to mail samples to a lab for processing and analysis. PCR stands for polymerase chain reaction. It’s a multi-step process conducted in a machine that amplifies DNA through a series of temperature-controlled cycles. The entire process from start to finish can take hours, but the turnaround time for a lab to report results can be one to three days.
Visby’s single-use test includes a collection kit and a powered testing device that communicates securely to a Visby mobile app. Visby said the companion app guides users through the testing process, the interpretation of results, and connection to additional healthcare options. Test results are displayed in the app in about 30 minutes.
In clinical studies, the Visby test yielded results comparable to traditional lab-based PCR machines. The FDA said the at-home test correctly identified 98.8% of negative and 97.2% of positive Chlamydia trachomatis samples; 99.1% of negative and 100% of positive Neisseria gonorrhoea samples; and 98.5% of negative and 97.8% of positive Trichomonas vaginalis samples. The FDA cautioned that like other diagnostic tests, the main risk of the Visby product is the possibility of false positive and false negative results.
Authorization of the new Visby test was made through FDA’s De Novo premarket review pathway, which is for new devices with low-to-moderate risk. As the first authorized product of its type, the Visby test now becomes the predicate device in a new regulatory classification. In the future, tests of the same type and intended use will be reviewed under the FDA’s 510(k) pathway, which will require them to show substantial equivalence to the Visby test.
In a prepared statement, Visby Medical founder and CEO Adam de la Zerda said his company has built a manufacturing line to rapidly scale production of the company’s new product. He added Visby plans to expand to OTC tests for other common indications, such as respiratory infections, sore throat, and urinary tract infections.
“This is just the beginning of our journey into reshaping healthcare through at-home diagnostics,” de la Zerda said. “We will soon announce several strategic and commercial partnerships.”
The FDA decision for Visby’s STI test is the second notable De Novo authorization in the past year. Last August, NOWDiagnostics’ First To Know became the first at-home syphilis test to pass this regulatory bar.
Photo by Visby Medical