The point-of-care platform with multifunctional capabilities provides results in as little as 15 minutes.

The Food and Drug Administration (FDA) has granted 510(k) clearance for Baebies‘ FINDER Flu A&B/SARS-CoV-2 Test, which also received CLIA-waiver approval. The rapid RT-PCR assay runs on the FINDER platform, establishing it as a molecular point-of-care platform with multifunctional capabilities, according to Baebies.

The automated system is designed for use in decentralized settings, including urgent care centers, emergency departments, and clinics. It delivers positive results in as early as 15 minutes and negative results in approximately 20 minutes.

“For too long, testing in decentralized settings has been fragmented across multiple instruments,” says Richard West, founder and CEO of Baebies, in a release. “This clearance expands our opportunity in urgent care, the ED, and other near-patient settings, and builds an installed base that can be leveraged to support multifunctional assays on the same platform.”

Technology and Workflow

The FINDER platform is powered by digital microfluidics, combining rapid PCR with integrated sample preparation in a fully enclosed cartridge. The workflow is designed to meet the demands of urgent care settings, which require speed and minimal hands-on time to support diagnostic decisions during a patient visit.

Beyond the respiratory test, the company is developing a broader molecular menu. This pipeline includes 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.

Multifunctional Platform Capabilities

The platform’s capabilities extend beyond molecular diagnostics. The system previously received FDA 510(k) clearance for a G6PD test, and its Anti-Factor Xa Test received FDA Breakthrough Device Designation as a point-of-care heparin monitoring assay.

“FINDER is designed to deliver the speed and menu breadth needed for single-visit diagnostic decisions, helping clinicians get patients the right care without sending them to multiple instruments or settings,” says Vamsee Pamula, PhD, founder and president of Baebies, in a release.

The company says the platform aims to make diagnostic testing more accessible in near-patient settings. The FINDER system was previously recognized with the Association for Diagnostics & Laboratory Medicine Disruptive Technology Award.

ID 109783430 © Vampy1 | Dreamstime.com

Related Reading: