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.