UPDATED MAY 6th, 2020
EDP Biotech has recently notified the US FDA, and received a listing on the FDA.gov FAQ website, related to its plans to perform COVID-19 serology (antibody) testing in the state of Tennessee. EDP Biotech’s mission has always been to develop and commercialize cost effective blood tests that detect disease early. While our top priority remains ColoPlex™ multiplex blood test for colorectal cancer and polyp detection, we recognize the high demand and supply shortage for serology testing in the United States. Serology testing for antibodies in the general population will be critical as the economy comes back to life and people return to work.
Please review and read the FDA FAQ Page here for more information.
As stated in Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests, while laboratories are encouraged to submit EUA requests for serology tests, the FDA does not intend to object to the development and use of serology tests to identify antibodies to SARS-CoV-2 by laboratories that are certified under CLIA to perform high-complexity testing, where the test has been validated, notification is provided to FDA, and information that helps users and patients understand the test results, such as the following, is included in the test reports:
- This test has not been reviewed by the FDA.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This policy does not apply to at-home testing, including at-home specimen collection.
EDP Biotech is currently pursuing additional licenses and approvals to begin antibody testing for customers in Tennessee. We are dedicated to offering high-quality, accurate tests from domestic manufacturers which have notified, applied for, or received FDA EUA. We expect to begin testing in May, and will have more pricing & availability details soon. Please check back often.