NEW YORK – Philadelphia-based startup Group K Diagnostics and laboratory medicine service firm Health Network Laboratories said today that they are collaborating in a clinical trial to validate the accuracy, effectiveness, and clinical implications of GKD's MultiNostic liver function test.
Clinical trial investigators will also analyze the impact of the microfluidic point-of-care test on operational efficiencies, GKD said.
HNL's Acting CEO and President Matt Sorrentino said in a statement that GKD's technology "may transform how and where certain diagnostic tests are performed."
The medical laboratory has more than 60 patient service centers throughout Pennsylvania and New Jersey, providing testing and related services for physician offices, hospitals, and long-term care facilities, among other healthcare settings.
According to GKD, the MultiNostic platform, operating from a blood drop, delivers results in 20 minutes and has potential to perform more than 40 blood tests. The firm is preparing to launch a six-biomarker liver function test in the US if it receives US Food and Drug Administration 510(k) clearance.
In March, it announced an agreement with the US Centers for Disease Control and Prevention to design and evaluate a prototype reverse transcriptase loop-mediated isothermal amplification (RT-LAMP) assay for the detection of Zika virus RNA at the point of care.