The guidance addresses cases in which there's enough evidence to conclude that the CDx is suitable for use with a specific group or class of oncology therapies.
The company, established as a merger between A*STAR MedTech spin-off MiRXES and venture capital firm Venturecraft, has developed a blood test for early-stage stomach cancer.
The proposal establishes procedures and criteria for the de novo classification of medical devices that would clarify requirements for submission and review.
November's modest gain followed a tough October, when the index down almost 9 percent. Meridian Bio paced the gainers, and NantHealth was the steepest decliner.
The company, which changed its name from Premaitha Health last month, saw a 73 percent increase in testing volumes during the first half of fiscal year 2018.
The partners are developing a point-of-care diagnostic kit that they anticipate will concurrently test for up to 20 types of infectious diseases in 20 minutes.
