2021
June 4, 2021
FDA issues Emergency Use Authorization for the oral fluid rapid test for SARS-CoV-2 antibodies, the CovAb™ SARS-CoV-2 Ab Test
On June 4, 2021 the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for emergency use of CovAb™ SARS-CoV-2 Ab Test pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. §360bbb-3).
| Device: | CovAb SARS-CoV-2 Ab Test |
| EUA Number: | EUA210017 |
| Company: | Diabetomics, Inc. |
| Indication: | Qualitative detection of total antibodies (including IgG, IgA and IgM) to SARS-CoV-2 in human oral fluid (gingival crevicular fluid – GCF). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Samples should only be tested from individuals that are 15 days or more post symptom onset. Emergency use of this test is limited to authorized laboratories. |
| Authorized Laboratories: | Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. |
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2020
December, 2020
CovAb™ has received CE marked status
CovAb™ has received CE marked status. This will enable healthcare providers in the EU to use the CovAb™ test for their patients. This is a first and a major regulatory milestone for COVYDx, and we expect other clearances to follow shortly.
July 24, 2020
COVYDx, Inc has closed a round of Series A financing
Series A financing supports manufacturing and commercialization of CovAb™ antibody test. The test will be manufactured in USA and sold through distributors. COVYDx projects initial manufacturing volume of 500,000 tests per month and scale-up to 1,000,000 tests per month by December 2020. CovAb™ point-of-care antibody test measures SARS-CoV-2 antibodies (IgA, IgM, IgG) in oral fluid, serum and plasma. This will be the first oral fluid rapid point-of-care antibody test, provides results in 15 minutes and does not need any instruments.
July 8, 2020
FDA Emergency Use Authorization (EUA) application submitted
COVYDx, Inc has submitted FDA EUA application for CovAb™ antibody test. CovAb™ point-of-care antibody test measures SARS-CoV-2 antibodies (IgA, IgM, IgG) in oral fluid, serum and plasma. This will be the first oral fluid rapid point-of-care antibody test, provides results in 15 minutes and does not need any instruments.