Exton-based Megna Health Announces FDA EUA Approval of COVID-19 Antibody Combo Test Kit

Exton-based Megna Health Announces FDA EUA Approval of COVID-19 Antibody Combo Test Kit

EXTON, PA — Megna Health, a medical technology company focused on the development and manufacturing of diagnostic and healthcare products, announced recently that the Company has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Rapid COVID-19 IgG and IgM Combo Test Kit.

Serology testing for COVID-19 is at an increased demand to better understand COVID-19 infections especially in asymptomatic patients or those who have recovered and developed antibodies. IgM antibodies are generally detectable in blood samples a couple of days after initial infection, and IgG antibodies follow later, then stay in circulation longer.

Antibody tests could be even more important to the reopening decision-making process since antibody tests indicate a certain degree of immunity for future infection. In contrast, diagnostic PCR tests can indicate the presence of viral material during infection and will not indicate if a person was infected and subsequently developed antibodies to prevent future infections.

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Megna’s Rapid Antibody Test Kit is lateral flow-based immune assay. It tests both IgM and IgG antibodies against the COVID-19 virus with only a drop of blood sample (less than 5uL) and reports result in less than 15 minutes.

In addition to studies in 411 patients, Megna’s Rapid Antibody Test Kit has also been validated independently by NIH/NCI (National Cancer Institute). It demonstrated sensitivity of 100 percent both combined (IgM/IgG) and IgG antibody.

“Our antibody kit is a first among combo (IgM and IgG) antibody test kits approved and manufactured in U.S. with such sensitivity,” said Eric Hill, Head of Marketing at Megna Health. “Simultaneous detection of IgM and IgG provides more important information to assess stage of infection and degree of immunity than individual assay alone.”

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