Medtech in a Minute: FDA Moves on COVID-19 and STD Testing

FDA Allows for First POC STD Test

FDA said Tuesday that it will allow the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent care settings, outpatient healthcare facilities and other patient care settings. The test, which uses female vaginal swabs and male urine specimens, is designed to detect the presence of the bacteria Chlamydia trachomatis and Neisseria gonorrhoeae, which cause the sexually transmitted infections chlamydia and gonorrhea, respectively. The ability to diagnose at a point-of-care setting will help with more quickly and appropriately treating sexually-transmitted infections, expert says.

FDA Moves on OTC and POC COVID-19 Testing

FDA said it is taking swift action to get more COVID-19 tests for screening asymptomatic people on the market. The agency has authorized several COVID-19-related tests for over-the-counter (OTC) use and some for point-of-care use. The agency says that screening testing, especially with OTC tests, is an important part of the country’s pandemic response as many schools, workplaces,and other entities are setting up testing programs to quickly screen for COVID-19.

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Would You Like Fries with That COVID Test?

Vault Health and Everlywell are reaching out to DoorDash in an effort to make FDA-authorized COVID-19 test collection kits more widely available to consumers. The Vault Health COVID-19 Saliva Test Kit and Everlywell COVID-19 Test Home Collection Kit DTC will be available for same-day delivery through the DoorDash marketplace app. The two digital health companies will focus on 12 DashMart locations across the United States, including Baltimore, Chicago, Cleveland, Dallas, Denver, Minneapolis, and Phoenix, with more cities rolling out in the coming months.

Another Testing Company Faces Fraud Charges

The Securities and Exchange Commission has filed litigation against the co-founders of San Francisco, CA-based uBiome, a now-defunct stool-testing company. They are accused of fraudulently raising millions of dollars and duping doctors into ordering unnecessary tests. The company developed and performed laboratory tests that purportedly identified microorganisms in the gut and genitals and assisted in the diagnosis of conditions such as inflammatory bowel disease and sexually transmitted infections.