BARDA has partnered with Nanomix, Inc. on the development of a COVID-19 rapid mobile test to diagnose COVID-19 infections with results in as little as 15 minutes. The test detects the presence of SARS-CoV-2 antigen in nasal and throat swabs. As part of the contract, a serological test will also be developed that can detect antibodies of SARS-CoV-2 in the blood, for indication of current or past COVID-19 infection.
The platform would test the patient for early evidence of infection allowing for rapid medical interventions and possibly curbing the spread of the disease. The test is being designed for near-patient locations such as hospitals, long-term care facilities, urgent care centers, and doctor’s offices, providing direct interaction with patients at the first point-of-contact, and greatly increasing the number of tests that could be run.
Nanomix’s advanced point-of-care diagnostic system, called the eLab® System has a rapid, easy to use, quantitative detection platform that performs a range of in vitro diagnostics assays. The platform consists of a hand-held reader and an integrated, self-contained, disposable, assay cartridge.
The disposable cartridge includes a biosensor and reagents to perform a highly sensitive electrochemical detection of viral particles or viral antibodies within a sample, such as a nose or throat swab. The second cartridge to be developed under the agreement will detect COVID-19 antibodies in blood samples. The assay is run by inserting the cartridge into the eLAB® Analyzer, which provides a test result within 15 minutes using an electrochemical ELISA detection method.
“Accurate, rapid and mobile testing is critical to slow the spread of COVID-19 and reduce the
devastating impact of this pandemic on the United States and the rest of the world,” said David
Ludvigson, president and CEO of Nanomix. “We are thankful that the U.S. government is
supporting our work to develop tests that are needed to battle SARS-CoV-2 in our communities
and could help people safely and confidently return to work and other critical functions.”
BARDA will contribute approximately $569,647 and Nanomix will provide the remainder of the estimated $876,000 costs. BARDA will also provide support so the company can accelerate FDA consideration of Emergency Use Authorization in the coming weeks.