Chembio Diagnostics, Inc. (CEMI) stock declined during the regular session on Tuesday, which continued sharply in the after-hours. While it lost 6.59% during regular trading, CEMI nose dived by 21.79% in the after-hours. No news from the company is responsible for the bearish momentum of the stock.
During the regular session, CEMI traded between $1.55 and %1.70, closing the session at $1.56. The stock tumbled further down in the after-hours to reach $1.22 at 806.46K shares.
Currently, the 30.05 million outstanding shares of the company trade at a market capitalization of $50.18 million.
CEMI’s FDA De Novo/510(k) Request
On December 06, CEI announced to have submitted De Novo/510(k) Request for the DPP SARS-CoV-2 Antigen test system to the FDA. Read with the DPP Micro Reader or DPP Micro Reader 2 optical analyzer, the test system can detect SARS-CoV-2 antigens within 20 minutes. Furthermore, it can also detect up to eight test results from a single patient sample.
Moreover, the company was awarded to support the development of the COVID-19 point-of-care antigen test system using its proprietary DPP technology by BARDA. Biomedical Advanced Research and Development Authority (BARDA) is a part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. In addition to the funding for the clinical studies, BARDA’s support also included preparation of De Novo/510(k) submission.
The company’s CEO and President, Richard Eberly shared his hopefulness for a straightforward review process with the FDA.
SHAPRA Approval
Previously, CEI had announced receiving SHAPRA approval for the DPP SARS-CoV-2 Antigen Test, on November 29. The South Africa Health Products Regulatory Authority (SHAPRA) approved the marketing and distribution of the test to professional healthcare providers.
Richard Eberly remarked on the approval to be another proof of the strong sensitivity and specificity performance of the test system. Moreover, CEMI will now be providing an additional testing solution to its distributor, Patient Focus Africa (PFA), to its SARA-CoV-2 IgM/IgG Antibody test. Furthermore, the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test, both are authorized by the company’s distributor pursuant to SHAPRA’s license.
Patient Focus Africa is accredited by the World Health Organization for near-patient testing, wellness, and professional point of care testing. Moreover, PFA is also owned partially by Discovery Health. Which is the largest private healthcare insurance provider in South Africa.
