The company's revenue growth resulted from acquisitions, but Quest faced headwinds from PAMA pricing and reductions in hepatitis C genotyping and vitamin D testing.
The new assay simultaneously detects four viral targets in donated blood plasma in a single sample and can add value to the biologics development space.
The firm noted that the premarket approval means that the three major viral load assays that most laboratories run for patients are now available on a single system.
The assays are for diagnosing hepatitis B infection in individuals with acute or chronic hepatitis B, or who are recovering from hepatitis B infection.