The test manufacturer is the first to gain IVDR certification for a companion diagnostic under the new regulation.
Increasing incidences of heart disease, as well as technological advances, will drive growth over the next eight to 10 years, reports say.
The market is expected to grow at a CAGR of 3.21 percent from 2021 to 2028 and reach $17.432 billion by 2028, according to a recent report.
Two PCR assays and a PCR point-of-care solution from three different companies aim to help with diagnosing cases, tracking new variants.
The creation of Global Access Diagnostics aims to expand affordable access to quality tests around the world.