CEMI Stock Price Increases Over 9% Pre-Market: Why It Happened

By Amit Chowdhry ● Aug 4, 2021
  • The stock price of Chembio Diagnostics Inc (NASDAQ: CEMI) increased by over 9% pre-market. This is why it happened.

The stock price of Chembio Diagnostics Inc (NASDAQ: CEMI) increased by over 9% pre-market. Investors appear to be responding positively to the FDA granting emergency use authorization to Chembio Diagnostics, which was reported by Benzinga yesterday afternoon.

The approval was for the LumiraDx SARS-CoV-2 Ab Test device. Back in March 2020, LumiraDx UK Ltd. had announced plans it entered a strategic partnership with Chembio Diagnostics to develop point of care test solutions for the detection and monitoring of the COVID-19 virus, and IgG and IgM antibodies. 

According to the FDA document, the LumiraDx SARS-CoV-2 Ab test is indicated for the following indications for use:

— For certain authorized laboratories – Qualitative detection of total antibodies to SARS-CoV-2 in human serum, plasma (dipotassium EDTA) and venous whole blood (dipotassium EDTA). Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

— For certain authorized laboratories – Qualitative detection of total antibodies to SARS-CoV-2 in fingerstick whole blood. Intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

— Samples should only be tested from individuals that are 15 days or more post-symptom onset.

— Emergency use of this test is limited to authorized laboratories

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