This story originally ran on June 10.
Proteomic diagnostic developer Correlogic this week announced that it had obtained CE marking from the European Union for its OvaCheck protein biomarker blood test for the detection of epithelial ovarian cancer.
The certification allows the company to offer OvaCheck commercially in Europe as it continues to seek FDA approval for the test in the US.
Sales of the test in Europe are still several months away, Correlogic CEO Peter Levine told ProteoMonitor.
"We're talking with a number of European distributors, and those talks haven't yet reached a conclusion," he said.
In the US, the Germantown, Md.-based company is undertaking the second arm of its original clinical trial, gathering additional data the FDA requested regarding patient populations being treated by non-specialist doctors.
"The first double-blinded trial was quite successful. Now it's just a matter of buttressing the original results," Levine said.
OvaCheck's road to FDA approval has been a long one. Correlogic began developing the test in 2002, but commercialization of the test was delayed in 2004 when the FDA warned the company that it would need to file for premarket approval (PM 2/27/2004). In 2007 the test ran into another obstacle when the FDA released its draft guidance on in vitro diagnostic multivariate index assays, indicating its goal to begin regulating tests like OvaCheck that use algorithms to interpret gene and protein data (PM 2/15/2007).
Correlogic's current timeline for completing the second arm of the trial is "many months out," Levine said, noting that he doesn't expect FDA approval for the test before the end of this year.