INDICAID receives 3-Month/90 day shelf-life extension to current expiration dates for numerous lot numbers.
(GARDEN GROVE, CA,) – May 8th, 2023 – PHASE Scientific Americas, a fast-growing biotechnology company, announces that its successful INDICAID® COVID-19 Rapid Antigen At-Home Test for OTC and INDICAID® COVID-19 Rapid Antigen Test for professional use has updated the shelf-life from 12 months to 15 months when stored at 36°-86° F (30 2-30°C) from the date of manufacture.
When COVID-19 started the printed expiration dates were determined by the U.S. Food and Drug Administration (FDA), and only approved a shelf-life of about four to six months, but further data shows that these tests continue to be accurate for months longer. If the testing company, like PHASE Scientific did last month, conducts a study of the longevity of the test and submits to FDA, they can be approved for a longer shelf life.
“PHASE is always monitoring how we can advance our products to provide the best for our customers,” said Felix Chao, General Manager of PHASE Scientific Americas. “Our testing of both our INDICAID® COVID-19 OTC and PoC products allows our customer the peace of mind that they are getting the best product with this ever changing virus.”
This year, PHASE has also tested and validated its INDICAID® tests to the multiple variants COVID-19 has spun. This validation is through the Rapid Acceleration of Diagnostics (RADx) initiative launched by the National Institutes of Health (NIH) at Emory University in Atlanta, Georgia. The INDICAID® tests were shown to detect these COVID-19 variants at lower concentration levels than the competitive products against which it was evaluated.
The FDA says it will continue to update the expiration dates of at-home rapid tests, but the current status of all tests is listed on the FDA website.
For more information about PHASE and the INDICAID® COVID-19 Rapid Antigen At-Home Test expiration extension, read the PDF letter/notice and check the lot numbers effected.
About PHASE Scientific Americas
PHASE Scientific is a fast growing biotechnology company dedicated to inspiring a new state of health. We are committed to providing patients and healthcare providers with innovative diagnostic and data tools that will assist them in understanding their health and making better health decisions. The company has its offices in Garden Grove, California and Atlanta, Georgia.
About the INDICAID® COVID-19 Rapid Antigen At-Home Test
The INDICAID® COVID-19 Rapid Antigen At-Home Test is authorized for non-prescription home use. INDICAID is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner. To learn more, visit our INDICAID product page(s).
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PHASE Scientific Americas