Biodesix scored itself a CE mark that will help expand access to its personalized lung cancer treatment test, a big milestone in the Colorado outfit's push to bring the product into more widespread use.
Its VeriStrat noninvasive blood test is designed to predict whether chemotherapy or the Roche ($RHHBY) cancer drug Tarceva will work best as a second-line treatment for nonoperable, advanced non-small cell lung cancer. Specifically, the CE mark covers its VeriStrat specimen collection and shipping kit, which will allow Biodesix to make VeriStrat results available to European Union physicians or those in other countries that recognize the CE mark.
The $3,480 diagnostic is already widely used in the U.S. when single-agent treatment options (such as for advanced non-small cell lung cancer) are on the table for patients with an EGFR-wild-type mutation or whose EGFR status can't be easily determined, a spokesperson told FierceDiagnostics. Those tests are processed in the company's CLIA-certified laboratory with results in under 72 hours.
In a major coup for Biodesix, VeriStrat has been covered for eligible U.S. Medicare enrollees since June 2013. Patients who can't obtain that or other insurance coverage can gain help through a financial support program, the company said. Diagnostics companies struggle to reach a viable market without government or private insurance reimbursement.
The serum-based test represents a solid advance in the field of medicine. The company's PROSE trial--a multicenter study of 285 patients that demonstrated that the test accurately predicted whether chemotherapy or Tarceva would work best--helped propel the new approval.
In January, Biodesix disclosed it pulled in another $6.1 million from a follow-on sale of preferred shares, on top of $8.2 million in initial Series E financing first announced in December that included both new funding and the conversion of a convertible note. That nearly $14.4 million combined cash infusion will help advanced VeriStrat's marketplace expansion.
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