NEW YORK (GenomeWeb News) — A newly formed group comprising genomic, proteomic, and molecular diagnostic companies and investors today said they plan to ask the US Food and Drug Administration to consider altering its plan to regulate certain diagnostic products.
The Coalition for 21st Century Medicine said it is focused on the FDA’s intent to regulate products the agency has termed in vitro diagnostic multivariate index assays, or IVDMIAs. The agency outlined IVDMIAs and their regulatory framework in a draft guidance last fall. The agency is scheduled to hold a public hearing on the document today.
The group said “the outcome of this discussion could profoundly impact the future of the diagnostics industry and the future of personalized medicine.”
The group said that if the guidance is implemented as drafted, “vital medical tests may become unavailable, innovation and improvements could be impeded, the cost of research and development could rise, and insurance coverage for laboratory tests could erode or disappear.”
The coalition includes Genomic Health, Fisher Healthcare, Nanogen, Bio-Rad, Ciphergen, Tm Bioscience, Combimatrix, Sequenom, Genetic Alliance and other biotech and medical research and equipment companies.
"Labs have been a significant source of innovation for decades. Laboratory-developed tests, including tests and services that would be considered IVDMIAs under the draft guidance, are an essential part of public health and are the future of personalized medicine,” said Tom Tsakeris, president of devices and diagnostics consulting group and former director of the FDA's Division of Clinical Laboratory Devices. “To preserve this future, FDA should go through formal rulemaking procedures and carefully consider the alternatives.”
As GenomeWeb News reported last fall, the FDA said IVDMIAs use mathematical formulas to interpret gene and protein data to guide medical decision-making. The FDA said such tests must be cleared by the agency; ordinarily they would be overseen by Clinical Laboratory Improvement Amendments regulations.
Regulations can have “unintended consequences,” the group said, and can hamper development and innovation of new products.
Paul Radensky, a coalition adviser, said in the statement that the coalition prefers a “formal FDA notice and comment” process for drafting rules and “urge[s] the FDA to pursue a process in which doctors, patients, and innovators can add their experience and voice to this important proceeding.”