DURHAM, N.C., March 31, 2026 /PRNewswire/ — Baebies announced FDA 510(k) clearance and CLIA-waiver approval for the FINDER® Flu A&B/SARS-CoV-2 Test, an ultra-rapid RT-PCR assay on the FINDER platform. This establishes FINDER as the first molecular point-of-care platform with multifunctional capabilities. The compact, automated system delivers PCR-quality results during the patient visit, with positives as early as 15 minutes and negatives in about 20 minutes, giving urgent care centers, emergency departments, clinics, and other decentralized settings the speed, ease of use, and reliability needed for better diagnostic decisions.
“For too long, testing in decentralized settings has been fragmented across multiple instruments,” said Richard West, Founder and CEO of Baebies. “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.”
Powered by digital microfluidics, FINDER combines ultra-rapid PCR with integrated sample preparation in a fully enclosed cartridge. Beyond this launch, Baebies is advancing a broader molecular menu spanning high-plex panels for pathogens detected from blood, urine, nasal and vaginal swabs, host-response transcriptomic assays, and quantitative PCR programs for HIV and HCV. That roadmap positions FINDER not simply as a fast PCR system, but as a more capable molecular platform built for real-world near-patient testing.
FINDER also extends beyond molecular. Baebies previously received FDA 510(k) clearance for the FINDER G6PD Test on an earlier version of the platform, and its FINDER Anti-Factor Xa Test received FDA Breakthrough Device Designation as the first point-of-care heparin monitoring assay. Together, these milestones establish FINDER as a multifunctional platform.
“Call it multimodal, multi-omic, or multifunctional, we have a robust pipeline across assay types,” said Vamsee Pamula, PhD, Founder and President 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.”
Baebies is a diagnostics company headquartered in Research Triangle Park, North Carolina. Baebies pioneered digital microfluidics, with 25+ million tests delivered globally. FINDER was awarded the ADLM Disruptive Technology Award. Driven by its mission Any Test, Anywhere, Everyone™, Baebies is shaping a future where diagnostic testing is accessible everywhere, delivering better healthcare for everyone.
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SOURCE Baebies Inc.
