NEW YORK (GenomeWeb News) – Vermillion's shares soared 92 percent to $2.56 in mid-afternoon trade on the Nasdaq today after the firm announced that a panel of the American Medical Association approved the company's application for a Category 1 CPT code for its OVA1 ovarian cancer test.
The new code assigned to OVA1 becomes effective Jan. 1, 2013.
Category I codes pertain to procedures that are consistent with current medical practice and are commonly performed. Tests and/or procedures coded as Category 1 have met certain criteria, such as approval by the US Food and Drug Administration, and have proven and documented clinical efficacy.
Gail Page, president and CEO of the Austin, Texas-based molecular diagnostics firm, called the decision by AMA's Current Procedural Terminology Panel "a major achievement for OVA1 and an endorsement for the unmet clinical need addressed by this important triage test."
The panel's decision was supported by several peer-reviewed publications and a decision by the Centers for Medicare and Medicaid Services to cover the test for Medicare, she added.
"The new CPT code is a critical step in advancing the commercialization of OVA1, as we believe it will help streamline claims processing and accelerate coverage and adoption by private payers," Page said.
OVA1 was launched in March 2010 following 510(k) clearance from FDA in September 2009.
The AMA issued its OVA1 CPT coding decision as it moves to revamp the coding structure for tests known as in vitro diagnostic multivariate index assays, or IVDMIA, as GenomeWeb Daily News sister publication Pharmacogenomics Reporter reported in the fall. IVDMIAs are now dubbed multi-analyte assays with algorithmic analysis, or MAAAs, by the AMA.