isothermal amplification
Momentum Builds for Amplification-Free Molecular Diagnostics, but Significant Hurdles Remain
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New systems to directly detect nucleic acids from patient samples are on the horizon, but still fall short of gold standard amplification-based techniques and likely face a difficult regulatory path.
The firm said it has begun clinical trials of a 15-minute test to detect chlamydia and gonorrhea and expects to submit it for 510(k) clearance and CLIA waiver.
The firm has updated its low-cost Hub instrument and pivoted its testing menu toward multiplex point-of-care panels.
The firm is also pursuing US Food and Drug Administration premarket approval for its test, which could help it achieve broader dissemination.
Sekisui Diagnostics, Aptitude Medical Systems Sign US Distribution Deal for POC COVID Test
Aptitude's assay is designed to detect SARS-CoV-2 in self-collected saliva or anterior nasal swab samples, providing results via a paired reader in 30 minutes.