July 1, 2025 | For patients who suffer negative health consequences from a delayed diagnosis, new-to-the-scene digital microfluidics (DMF) technology for multifunctional testing can literally save lives. A standout in the field is Baebies (Durham, North Carolina), which has developed a pair of such platforms cleared by the U.S. Food and Drug Administration (FDA) intended for rapid point-of-care testing to aid diagnostic testing in newborns.
No FDA-cleared multifunctional testing devices can handle all modalities of testing, points out Vamsee K. Pamula, Ph.D., founder and president of Baebies. The closest might be Abbott’s i-STAT handheld blood analyzer that can simultaneously run some modalities of testing such as immunoassays and chemistry tests, but not all. “The flexibility in digital microfluidics is that it allows us to perform all types of tests on a single analyzer and even within the same cartridge.”
Baebies’ FINDER platform received FDA clearance in 2022 for the rapid detection of glucose-6-phosphate dehydrogenase (G6PD) deficiency, delivering results in about 15 minutes from a drop of blood at the point of care. G6PD testing typically requires two different tests, one to assess G6PD activity and another to measure hemoglobin or the number of red blood cells to interpret the results, he says.
FINDER supports a broad range of assay types—e.g., molecular, chemistry, immunoassays, and coagulation tests. Work is underway on near-patient testing for hematology and infectious diseases to address clinical needs in urgent care centers and emergency departments, Pamula says.
FINDER G6PD is the company’s first FDA-cleared test and is being used on-site at hospitals in New York, Boston, and beyond, says Pamula. Baebies has also received an FDA breakthrough award for its anti-factor Xa assay for heparin monitoring under the coagulation testing space and is submitting a respiratory infection panel (flu A and B, RSV, and SARS-CoV-2) using PCR under the molecular category, he adds. Tests in immunoassays and other categories are under various stages of development.
The company’s SEEKER platform received FDA de novo clearance in 2017 for newborn screening of lysosomal storage disorders, rare inherited conditions such as MPS I (Hurler syndrome), Pompe (glycogen storage disease type II), Gaucher, and Fabry diseases. SEEKER performs multiple enzymatic assays simultaneously from each newborn’s dried blood spot. A total of 192 assays are performed on 48 samples within each cartridge. Over 22 million newborn screening tests have been performed on this platform.
Pamula launched the company a decade ago with Richard West, after the pair sold the DMF technology of their prior venture (Advanced Liquid Logic) to Illumina. Earlier this year, after the newborn screening business of Baebies was licensed by Belgium's LaCAR MDx Technologies, the focus has been squarely on FINDER with its record-breaking five-minute PCR and expanding the multifunctional capabilities.
The multifunctional capabilities of FINDER will be the topic of a presentation by Pamula at the upcoming Next Generation Dx Summit. This will include its applicability in sepsis (all modalities), trauma (chemistry, coagulation, and immunoassays), and hepatitis (molecular and chemistry).
FINDER, an instrument roughly the size of a toaster, accepts DMF cartridges. Each of these comes pre-loaded with different reagents to perform specific tests that are designed for a “CLIA waivable workflow,” Pamula says, meaning all the usual sample prep steps are integrated into the cartridge.
“The user workflow is three scans with an in-built barcode scanner—scan of user ID, cartridge, and patient sample ID—and one load of the sample with a disposable transfer pipette,” he explains. “These cartridges are designed for single patients... because we are aiming for fast results and to avoid any cross contamination.”
Cartridges also have “limited real estate,” although droplet pathways use this restricted physical space well, Pamula adds. There is, however, no specific ceiling on the number of assays that can be performed on a single cartridge since the space can be reused by multiple droplets. “We have demonstrated a 12-plex PCR assay on these cartridges.”
The potential of the FINDER platform extends to clinical scenarios such as sepsis, trauma, and hepatitis where multifunctional testing is required, as Pamula will discuss during his conference presentation. Hepatitis, for example, initially requires an antigen followed by PCR and then liver function chemistry, which today requires multiple patient visits, he says. “If tests can be combined into a single visit in a test-to-treat model, then appropriate, direct-acting antivirals for Hep C can be prescribed in a single visit.”
The value of multifunctional syndromic testing stems from the fact that patient symptoms are not organized in the same way as labs and testing platforms are currently, says Pamula. “With advances such as digital microfluidics, multiple types of tests can be performed on the same sample at the same time in the same visit to address the symptoms as they are without having to divide the patient sample and send to multiple instruments in different labs.”
That level of efficiency will lead to faster, better, and cheaper patient care. The “time has come” to move syndromic testing beyond molecular testing to encompass multiple types of testing modalities, he says.
Elsewhere, efforts to build multifunctional devices are underway by startups Cubit Diagnostics (combined immunoassay and PCR system) and Fluxergy (molecular testing, immunoassays, clinical testing, and cytometry), and Sandia National Laboratories (notably, its SpinDx technology that integrates immunoassays, molecular diagnostics, and hematology).