OTC testing
The firm expects to pioneer a new diagnostics space with its over-the-counter, home-use STI panel.
FDA Authorizes Visby Medical At-Home MDx Test for Chlamydia, Gonorrhea, Trichomoniasis
The 30-minute test detects three sexually transmitted infections from a vaginal swab at home.
Co-Diagnostics Withdraws FDA COVID Test Submission, Plans New Version of Test
The company now intends to submit an enhanced version of its COVID-19 test for 510(k) clearance.
The firm plans to apply more than $10 million in recent Gates Foundation grants toward regulatory submission of a rapid STI test.