Point-of-care diagnostic company Chembio Diagnostics has made a De Novo/510(k) Request submission to the US Food and Drug Administration (FDA) for its Covid-19 antigen test system.
The new dual path platform (DPP) SARS-CoV-2 Antigen test system is capable of detecting the virus antigens from a minimally invasive nasal swab sample and provides results within 20 minutes.
The results can be read using a DPP Micro Reader or DPP Micro Reader 2 optical analyser.
Chembio’s test has been developed using the company’s DPP technology, which has the ability to detect up to eight, distinct test results from the sample of a single patient.
The company received an award from the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to support the rapid DPP SARS-CoV-2 Antigen test system development.
The award also included funding to complete clinical studies as well as preparation for submitting a De Novo/510(k) for the new Covid-19 point-of-care system.
Chembio president and CEO Richard Eberly said: “The De Novo/510(k) Request for the DPP SARS-CoV-2 Antigen test system reflects our long-term strategy and commitment to deliver rapid, decentralised Covid testing solutions and broaden our portfolio of products in other disease categories that require rapid results for the US market.
“We would like to thank BARDA for their collaborative efforts in the development of both our Covid-19 tests and the respective regulatory submissions.
“We are hopeful for a straightforward review process with the FDA in order to offer healthcare providers additional testing solutions to support the evolving needs of the pandemic.”
The company’s DPP-based point-of-care tests that have secured regulatory approvals from the FDA include the DPP Ebola Antigen System and DPP Zika IgM System as well as the DPP HIV 1/2 Assay and DPP HIV-Syphilis System.
In 2018, Chembio Diagnostics received EUA from the US FDA to use its DPP Ebola Antigen System for the detection of the Ebola virus.