Rapid Point-of-Care RT-PCR Test Differentiates Influenza A/B and SARS-CoV-2 in Minutes

Respiratory viruses such as influenza A/B and SARS‑CoV‑2 continue to burden urgent care and emergency settings, where rapid, reliable differentiation guides therapy and infection control. Molecular assays provide high analytical accuracy but often require centralized laboratories or single‑purpose point‑of‑care instruments that fragment workflows. A newly cleared molecular point‑of‑care test now delivers PCR‑quality results during the patient visit while enabling a multifunctional platform that extends beyond molecular testing.

The FINDER Flu A&B/SARS‑CoV‑2 Test, an ultra‑rapid reverse transcription polymerase chain reaction (RT‑PCR) assay run on the FINDER system, received U.S. Food and Drug Administration (FDA) 510(k) clearance together with a Clinical Laboratory Improvement Amendments (CLIA) waiver. With this dual determination, the system is identified as the first molecular point‑of‑care platform with multifunctional capabilities. The compact, automated instrument is intended for decentralized sites, including urgent care centers, emergency departments, and clinics.

Image: FINDER is the first molecular point-of-care platform with both FDA 510(k) clearance and CLIA waiver that combines molecular testing with chemistry, coagulation, and immunoassay capabilities on a single multifunctional system (photo courtesy of Baebies)

Powered by digital microfluidics, the system integrates sample preparation and amplification within a fully enclosed, single‑use cartridge. A simple three‑step workflow is described, minimizing hands‑on time and obviating complex laboratory infrastructure. Reported turnaround time is as early as 15 minutes for positive results and about 20 minutes for negatives, enabling same‑visit decisions with PCR‑quality performance.

According to information provided, the platform combines molecular testing with chemistry, coagulation, and immunoassay capabilities on one system. Beyond the newly cleared respiratory assay, the manufacturer notes a broader molecular menu in development, including high‑plex pathogen panels for multiple specimen types, host‑response transcriptomic assays, and quantitative PCR programs for HIV and hepatitis C virus. The platform previously received FDA 510(k) clearance for the FINDER G6PD Test on an earlier version, and its Anti‑Factor Xa Test holds FDA Breakthrough Device Designation as the first point‑of‑care heparin monitoring assay.

"This clearance expands our opportunity in urgent care and other near-patient settings, and builds an installed base that can support our expanding menu of multifunctional assays. This milestone reflects the extraordinary work of our team and creates a scalable path to new revenue opportunities as additional tests are introduced," said Richard West, Founder and CEO of Baebies.

“FINDER is designed to deliver the speed and test menu breadth for single‑visit diagnostic decisions, helping clinicians get patients the right care without sending them to multiple instruments,” said Vamsee Pamula, PhD, Founder and President of Baebies.