Chembio Diagnostics has unveiled its plans to seek the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the revised DPP Covid-19 IgM/IgG system and the new DPP Covid-19 Antigen system.
DPP Covid-19 IgM/IgG system is a Covid-19 point-of-care serology system, while the DPP Covid-19 Antigen System is a new Covid-19 point-of-care antigen system.
Chembio has revised its DPP Covid-19 IgM/IgG system with the objective of meeting the FDA’s new criteria.
Chembio president and chief executive officer Rick Eberly said: “We believe recent positive feedback from a number of customers confirms that our rapid DPP Covid-19 IgM/IgG System can add tremendous value in quickly evaluating patient Covid-19 IgM and IgG antibody values in a variety of settings.
“We remain confident that the unique features and benefits of our test platform will make it one of the preferred solutions for antibody testing worldwide. In modifying our serology system, we are seeking to respond to the FDA’s new performance criteria, as well as the rapidly evolving scientific and clinical understanding of the virus that led to the adoption of those criteria.”
Chembio’s DPP Covid-19 IgM/IgG system was granted an EUA in April
Comprising Chembio’s serology test for Covid-19 and a DPP Micro Reader analyser, the DPP Covid-19 IgM/IgG system was granted an EUA by the FDA in April 2020.
According to the FDA performance review based in part on National Cancer Institute (NCI) process for the evaluation of Covid‑19 serology tests, the company’s Covid-19 IgM/IgG System that uses a panel of pre-selected samples may not indicate either performance in the real-world or of finger stick blood.
The US regulatory agency revoked the EUA for the DPP COVID-19 IgM/IgG system on 16 June.
The company intends to apply for an EUA for the revised system during the third quarter of 2020.
The DPP Covid-19 Antigen System is planned to comprise a DPP Covid-19 antigen assay and a DPP Micro Reader analyser and is expected to use a nasal or nasopharyngeal swab to detect Covid-19 antigens.
The company is planning to develop the new system using the DPP platform, with an aim to provide Covid-19 detection for diagnosis at the point of care, and offer improved clinical outcomes.
Chembio has won a contract from the Biomedical Advanced Research and Development Authority (BARDA), to help the company in developing a Covid-19 antigen system and seeking the FDA EUA for the system.
Eberly added: “We intend to bring an antigen system to market to help with the rapid and direct detection of the Covid-19 virus. As with other DPP-based systems, we expect it to run in approximately 15 minutes without requiring the significant up-front investment and infrastructure needed for molecular detection systems.
“We believe a simpler, point-of-care design based on our DPP technology will be able to help identify infection rates closer to real time, where and when needed.” –NSMedical