BARDA is partnering with Aptitude Medical Systems to accelerate development of two at-home molecular diagnostic tests for COVID-19 and influenza. The Metrix COVID-19 Test is being designed for sensitive and specific detection of SARS-CoV-2, and the Metrix COVID/Flu multiplex test is being designed to detect and differentiate SARS-CoV-2, influenza A and B.
Aptitude Medical Systems announced today that it has received an award up to $53.7 million from Biomedical Advanced Research and Development Authority (BARDA).
The funding supports the development of over-the-counter molecular diagnostics capable of delivering lab-quality results in 15-30 minutes while approaching the cost of antigen tests.
BARDA is part of the Administration for Strategic Preparedness and Response within the US Department of Health and Human Services.
The first phase of the award will build out Aptitude’s MetrixTM testing platform through $19.6 million in funding to develop and validate at-home COVID and COVID/Flu tests. Additional funding options worth up to $34.1 million may be exercised to develop multiplex tests for other infectious disease threats.
This BARDA award will support development of these diagnostics through FDA 510(k) clearance.
Aptitude’s COVID-19 Test is the first product on the Metrix platform and received Emergency Use Authorization from the FDA in Oct 2022. It will be closely followed by the Metrix COVID/Flu Test and software to integrate patient, providers, payers, and public health.
Metrix tests enable the use of nasal swabs or saliva samples (depending on disease) and require inserting a disposable cartridge into a reusable reader, providing results in 15 to 30 minutes. The use of either saliva or nasal swabs as the clinical specimen increases access to high quality diagnostics by leveraging an easily collected sample.
Upper respiratory illnesses, such as COVID-19 and the flu, can cause similar symptoms, especially in early stages of infection. At-home diagnostics can empower individuals with actionable information about their infection status so that they can self-isolate and seek medical care and treatment early in the course of any infection.
Aptitude aims to make molecular tests as accessible as antigen tests, according to JP Wang, PhD, Aptitude CSO and co-founder. “The value of that upgrade is clear – a PCR-quality molecular test means that you can detect an infection earlier to avoid spreading to your family, friends, and coworkers. Antiviral treatments are significantly more effective if given at the start of an infection –not mid-infection. So, detecting sooner means you can recover sooner because the treatments actually work better. Traditional healthcare is too slow to deliver this value to most people.”
Sources: Biomedical Advanced Research and Development Authority (BARDA), Aptitude Medical Systems