Megna Health Announces Submission of Application to the FDA for Emergency Use Authorization of its Rapid COVID-19 IgG & IgM Antibody Test for Prescription Home Use
EXTON, Pa., May 24, 2021 /PRNewswire-PRWeb/ — Megna Health, a U.S. manufacturer of Rapid COVID Tests based in Exton, Pennsylvania, announced that it has filed a U.S. Food and Drug Administration (FDA) EUA (Emergency Use Authorization) extension for Prescription Home Use for its Rapid COVID-19 IgG/IgM Antibody Test and is preparing for product launch. The test is performed in 15 minutes with one drop of fingerstick sample with no additional equipment needed.
Megna Health has already received its Emergency Use Authorization for use in CLIA waived and Point of Care Settings with fingerstick whole blood samples. Designation of Prescription Home Use will be an extension of its current use and require a prescription from a healthcare provider. The Rapid COVID-19 IgG/IgM Antibody Test has been used in the United States and Internationally since July of 2020 and was validated by the National Institutes of Health with a combined sensitivity of 100 percent and specificity of 95 percent.
Currently, Megna Health is one of only five companies that offer a rapid combo IgM/IgG antibody test that has Emergency Use Authorization for CLIA Waived and Point of Care Settings and the Prescription Home Use designation will be the first, once granted the EUA.
Rapid COVID-19 tests are convenient and will allow individuals the convenience of testing themselves at home instead of traveling to a clinic. Megna Health strives to be the leader in affordable and accurate rapid COVID-19 tests produced in the United States.
Megna Health is currently developing its network of telehealth providers along with their pharmacy partners that will distribute the test.
About Megna Health
Megna Health provides life-changing diagnostic and healthcare products. The company is headquartered in Exton, PA and the antibody combo test kits are manufactured in facilities in Pennsylvania as well. For more information visit http://www.megnahealth.com
Media Contact
Bret Anderson, Megna Health, +1 (610) 590-1768, marketing@megnahealth.com
SOURCE Megna Health
