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
