PCR arrives home through FDA-authorized Visby's OTC sexual health test
PCR is the primary host in diagnosis, but whether it is collecting samples in the clinic or at home, such tests require sending the samples to the lab and then waiting for results. The new FDA licensed by Visby Medical essentially takes the lab into the hands of users.
The FDA on Friday granted Visby Medical’s marketing authorization for women’s health tests, a diagnosis of three sexually transmitted infections (STIS): chlamydia, gonorrhea and trichomonisis. The FDA said the Visby product was the first diagnosis that could be purchased without a prescription and was tested for all three pathogens at home.
Home-based STI tests are already available, but they still require users to mail samples to the lab for processing and analysis of the test collection kit. PCR stands for polymerase chain reaction. This is a multi-step process in a machine that amplifies DNA through a series of temperature-controlled cycles. The entire process from start to finish can take several hours, but the turnaround time for lab-reported results can be one to three days.
Visby's one-time test includes a collection kit and an electric test device that communicates securely to the Visby Mobile application. Visby said the companion app guides users through the testing process, explanation of results, and connections to other healthcare options. The test results are displayed in the application within about 30 minutes.
In clinical studies, the results obtained by Visby tests are comparable to those of traditional laboratory-based PCR machines. The FDA said the at-home test correctly identified 98.8% of negative tests and 97.2% of trachoma anode samples; 99.1% negative and 100% gonorrhea positive samples; and 98.5% negative and 97.8% vaginal samples. The FDA warns that, like other diagnostic tests, the main risk of Visby products is the possibility of false positive and false negative results.
The authorization for the new Visby test is conducted through the FDA's Novo Premarket Review Pathway, a pathway that is suitable for new devices with low to moderate risks. As the first authorized product of this type, Visby Testing is now a predicate device in the 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 be the same as Visby tests.
Visby Medical founder and CEO Adam de la Zerda said in a prepared statement that his company has established a manufacturing line to quickly expand the company's new products. He added the Visby program to expand to OTC tests for other common indications, such as respiratory infections, sore throats and urinary tract infections.
“This is just the beginning of our journey to reshape healthcare through family diagnosis,” Drazelda said. “We will announce several strategic and business partnerships soon.”
The FDA decision for the VISBY STI test is the second major reinstatement authorization in the past year. Last August, NowDiagnostics first knew to be the first time that it passed the syphilis test on the regulatory column.
Photo by Visby Medical
