Chembio Diagnostics’ shares closed on Monday up 60 percent on the company’s announcement last week that it is launching a rapid test for the detection and differentiation of SARS-CoV-2 antigens, influenza A, and influenza B in decentralized and traditional testing settings.
The firm’s stock traded as high as $6.25 per share on Monday on the Nasdaq before finishing the day at $5.64 per share.
In early morning trading on Tuesday, Chembio’s stock was down was down 13 percent to $4.91.
A Chembio spokesperson recently told 360Dx that it has inked a licensing agreement for the test with an undisclosed manufacturer, which had received US Food and Drug Administration Emergency Use Authorization.
On the company’s fourth quarter earnings call in March, Richard Eberly, Chembio’s president and CEO, said that its first objective for 2021 is to “launch the point-of-care EUA approved, in-license respiratory panel product in the United States.”
The firm said last week that it is ready to ship the test to US customers.
The rapid immunoassay, authorized for use in laboratories with a CLIA waiver, provides results in 15 minutes using a single swab and requires no instrumentation, Chembio said.
In December, the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded Chembio $12.7 million, partly to develop a multiplex DPP Respiratory Antigen Panel point-of-care system for use during the flu season.
Last year, the FDA had revoked an EUA granted to the firm for an antibody test due to performance issues, and the agency declined to review an antibody test that it subsequently developed.
With a legacy of supplying rapid diagnostic immunoassay tests to low- and middle-income countries, the firm is now focused on supplying point-of-care diagnostic tests in the US, the European Union, and Brazil.