Originally published Aug. 24.
Arrayit said this week that it has submitted an application for premarket approval with the US Food and Drug Administration for its OvaDx Pre-Symptomatic Ovarian Cancer Screening Test.
"While the standard for a PMA is higher than for a 510(k), the company believes that a PMA OvaDx submission can achieve a Class III PMA approval, the most stringent approval level granted by the FDA for in vitro diagnostic devices," the company said in a statement.
OvaDx was developed in house by Arrayit President Mark Schena. The test employs a microarray-on-a-planar-surface format and is serum-based.
Although Arrayit had previously said it would pursue 510(k) clearance for OvaDx, Schena told PGx Reporter this week that the company chose the PMA path in order to prove that the technology platform for OvaDx could "pass muster in a rigorous clinical trial," and differentiate the test in the marketplace.
Additionally, FDA's stated intent to lift "enforcement discretion" over higher-risk laboratory-developed tests also influenced Arrayit's decision to go the PMA route (PGx Reporter 07/21/10).
"Certainly the sense we're getting from the FDA is that there is an increasing sensitivity on the part of the agency for non-approved tests," Schena said. "So, we felt that … the FDA seems to be heading [toward] greater regulation of tests, rather than lesser regulation."
The message from the agency's recent regulatory action against direct-to-consumer genomic testing companies also suggests that under the agency's definition of "risk," a test's potential for harm to public health increases in proportion to the number of people the test is marketed to (PGx Reporter 07/28/10).
"Given the fact that we will be recommending OvaDx as a general screening tool for ovarian cancer, we felt that it was more appropriate to subject the test to a rigorous clinical trial in advance of marketing the product," Schena added.
Arrayit has discussed and planned its regulatory submission strategy with FDA. Furthermore, the company has engaged the oncology contract research organization Docro to guide its pivotal studies for marketing approval. Schena said that the company is conducting a retrospective trial using 500 patient samples, and then validating those findings in a 2,000-patient prospective, blinded trial.
According to Arrayit, OvaDx gauges presence of approximately 100 protein biomarkers in serum to detect ovarian cancer as early as five years before symptoms appear. The company estimates that early detection of ovarian cancer, which is often caught after it has spread beyond the ovaries into other organs and tissues, could potentially improve long-term survival of early-stage patients to 90 percent compared to 10 percent of late-stage patients.
Arrayit said that, upon garnering FDA approval, it plans to market the test to HMOs, physicians, and other healthcare providers.