Sequenom said in an SEC document that its SensiGene test, which the company believes was cited by the FDA for being improperly marketed without FDA approval, is an LDT and meant "solely for use within our CLIA-certified and CAP-accredited laboratory."
According to one high-ranking FDA official, the agency is considering downgrading in risk classification certain regulated tests as a way to manage its limited resources; phasing in regulation of LDTs that aren't currently regulated; collaborating with the NIH to develop a test registry that could serve FDA's purposes for keeping an eye on all test developers; and possibly enlisting the help of third-party inspectors to help the agency with its increasing regulatory burden.
The Pharmaceuticals and Medical Devices Agency's decision follows similar decisions by the FDA and EMA in 2008, which allowed data generated using the seven-biomarker panel to be included in the drug approval process.
Epigenomics' PCR-based lung cancer reflex diagnostic test has been validated in a key clinical trial, clearing the way for the test to receive the CE Mark for in vitro diagnostics and for the company to launch the test in Europe in coming weeks.
The provisions for the EU orphan designation provide incentives to companies developing orphan drugs, including the potential for up to 10 years of market exclusivity and various fee reductions for certain regulatory activities, Quark said.
The AMA's CPT Editorial Panel held a meeting in which stakeholders continued ongoing discussions regarding a new CPT coding structure in the works for molecular diagnostics and genetic tests. The new coding structure is expected to take hold in 2012.