Baebies Receives First-of-its-Kind FDA Clearance and CLIA Waiver for FINDER® Flu A&B/SARS-CoV-2 Test
Baebies has announced that its FINDER® Flu A&B/SARS-CoV-2 Test has received both U.S. Food and Drug Administration (FDA) 510(k) clearance and CLIA waiver approval.
The decision marks an important step for the FINDER platform, positioning it as a molecular point-of-care system with multifunctional testing capabilities.
The FINDER system uses ultra-rapid RT-PCR technology and is designed to deliver laboratory-quality results directly at the patient’s side.
It can produce positive results in as little as 15 minutes and negative results in around 20 minutes.
The compact and automated format is intended for use in urgent care centres, emergency departments, clinics, and other decentralised healthcare settings, supporting faster clinical decision-making.
The platform is powered by digital microfluidics, which enables rapid PCR testing alongside integrated sample preparation within a sealed cartridge.
This design reduces handling steps and supports ease of use in near-patient environments.
Beyond respiratory testing, the FINDER system is being developed to support a wider range of diagnostic applications.
These include multi-pathogen panels, host-response assays, and quantitative PCR tests for infections such as HIV and hepatitis C, reflecting its broader aim as a flexible molecular diagnostics platform.
Earlier regulatory clearances for tests such as G6PD and anti-factor Xa further expand its clinical utility across different areas of point-of-care testing.
