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Biotech Gains $53.7M Infectious Disease Test Award

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, in orange, emerging from cells (NIAID, Flickr)

21 Apr. 2023. A maker of diagnostics for infectious diseases is receiving a $53.7 million contract to develop and validate reliable home molecular tests for Covid-19 and flu infections. Aptitude Medical Systems in Goleta, California says the Biomedical Advanced Research and Development Authority or BARDA is awarding the contract for advancing the company’s over-the-counter Covid-19 and influenza tests through full FDA authorization.

Aptitude Medical Systems develops diagnostics for infectious diseases that it says are simple and easy to use, while providing the accuracy and reliability of high-powered molecular tests found in commercial labs, such polymerase chain reaction or PCR tests. The company’s biosensor technology is based on aptamers, short single strands of nucleic acid molecules that bind to precise protein targets, and once linked, bind strongly to those targets. In addition, aptamers conform to the chemical structure of their targets, providing a wider range of targets than antibodies that connect epitopes to antigens.

In a paper published in Dec. 2016, Aptitude Medical’s founders, Jinpeng Wang, Jackson Gong, and Scott Ferguson — respectively Aptitude Medical’s chief scientist, chief operating officer, and CEO — demonstrated with colleagues a system using DNA aptamers that screened simultaneously for three separate protein targets in human blood serum. In addition, the team showed their aptamer screens outperformed high-quality monoclonal antibodies used in standard enzyme-linked immunosorbent assay or ELISA diagnostics in many of today’s medical labs. In an Apr. 2021 paper, the Aptitude Medical founders with colleagues from Google show how machine learning algorithms can refine the discovery process to identify the highest-performing and more compact aptamers.

“Test results on the spot”

Aptitude Medical’s lead product is the Metrix Covid-19 test that the company says takes nasal swabs and saliva samples and returns lab-quality molecular test results for the SARS-CoV-2 virus in 15 to 30 minutes. In Oct. 2022, Food and Drug Administration issued an emergency use authorization for the Metrix Covid-19 test, a single-use test sold over-the-counter without a prescription and conducted at home. “Metrix disrupts point-of-care testing by eliminating reliance on a bulky, expensive instrument and delivers a low-cost consumable simultaneously,” says Wang in an Aptitude Medical statement. Wang adds, “A patient can interact with their health care provider either physically or virtually, get powerful test results on the spot, and have their prescriptions waiting for them in a seamless experience.”

The BARDA contract funds continued development of the Metrix Covid-19 test and a combined Metrix test for Covid-19 and influenza, through full authorization by FDA, known as 510(k) clearance or premarket notification. In the 510(k) process, medical device developers need to show their products are safe, effective, and substantially equivalent to similar medical devices already on the market, in this case for point-of-care and in-home use.

Aptitude Medical says the contract provides up to $19.6 million to advance the Metrix Covid-19 and Covid-19/flu tests, with an optional $34.1 million for similar diagnostics testing for other infectious diseases. The company says the Metrix technology can also analyze blood and urine samples, as well as saliva and nasal swabs.

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