NEW YORK – Genalyte said this week that it has received US Food and Drug Administration 510(k) clearance for a thyroid stimulating hormone (TSH) immunoassay on its silicon chip-based Maverick testing platform.
According to Genalyte, the TSH assay delivers results in roughly 30 minutes and is the first quantitative immunoassay cleared on a silicon chip-based device. TSH is the most commonly ordered immunoassay lab test in the US, the company said.
The clearance marks a step forward for Genalyte in its goal of developing the Maverick as a benchtop device capable of performing a wide range of routine blood tests at the point of care.
"This TSH assay is a powerful tool to rapidly diagnose patients and get them on a path to treatment quicker," Genalyte CEO Ashraf Hanna said in a statement. "This technology is groundbreaking for immunoassay development, which hasn’t changed conceptually since 1959."
The company said it is pursuing FDA clearances for several additional tests.