NEW YORK (GenomeWeb News) - The US Food and Drug Administration yesterday classified gene-expression based breast cancer prognostic tests as Class II devices and released a “special controls” guidance for companies developing such tests.
The document is designed as a prototype guidance that will “provide a general framework” for how the FDA’s Office of In Vitro Diagnostics approaches so-called IVDMIAs, or in vitro diagnostic multivariate index assays, Steve Gutman, OIVD’s director, told GenomeWeb News via e-mail.
The FDA cleared the first such IVDMIA device – Agendia’s MammaPrint test – in February. In a Federal Register notice yesterday, the agency explained that it had originally classified MammaPrint as a Class III device, which would have required full premarket approval, but Agendia filed a petition requesting that the device be reclassified into Class II, which only requires 510(k) premarket notification.
FDA said that it determined that MammaPrint — as well as future genomic breast cancer prognostics — can be classified as class II devices “with the establishment of special controls,” which are outlined in the guidance document.
“Any firm submitting a 510(k) premarket notification for a gene expression profiling test system for breast cancer prognosis will need to address the issues covered in this special controls guidance,” the agency said in the document.
The recommendations in the guidance document apply to RNA expression assays used for cancer prognosis, including RT-PCR and gene expression microarrays, in which “an algorithm is applied to such measurements to yield a result that can be used by physicians as a prognostic marker, in combination with clinicopathological factors, to assess the risk of cancer recurrence,” the FDA said.
Gutman told GenomeWeb News that the newly issued recommendations are not currently supported by any regulations.
“The FDA does not usually draft regulations to outline technical review requirements,” Gutman stated. Rather, it prefers issuing guidances, which are less binding and are easier to revise than regulations.
The process for reviewing such tests is “contingent on the intended use of the device,” Gutman said, “and so design of studies and data sets required will be influenced by a particular use.” In this instance, a test for the prognosis of breast cancer would require different data than a test used to diagnose the disease, he said.
Gutman said that “a number of tumor markers” have already cleared as Class II devices.
The Federal Register notice announcing the classification of gene expression profiling test systems for breast cancer prognosis is available here, while the guidance document is available here.