Arrayit Corp announced that the company has appointed DOCRO Inc of Seymour, Conn, to assist in obtaining FDA approval for OvaDx.
DOCRO has steered nearly 100 In Vitro Diagnostic (IVD) clinical trials through the Food and Drug Administration in the past 12 years, along with 39 pre‐market approval (PMA) and 46 510(k) applications. DOCRO has an unparalleled 99% success rate with the FDA.
Arrayit’s OvaDx pre‐symptomatic ovarian cancer test will be the market’s first comprehensive diagnostic screen for ovarian cancer, and will be recommended for all women over the age of 35. OvaDx uses approximately 100 proteomic biomarkers in a microarray format to identify molecular beacons of ovarian cancer that accumulate in the bloodstream as a result of the body’s natural immune response to developing ovarian tumors. Arrayit’s microarray test, which detects both early and late stage ovarian cancer, leverages the company’s patented microarray platform and distinguished 13‐year track record as a microarray technology leader. OvaDx will be marketed and sold by the company’s subsidiary Arrayit Diagnostics Inc, in Houston.
"We are pleased to retain DOCRO for FDA approval of OvaDx," stated Arrayit CEO Rene Schena. "DOCRO brings a breadth and depth of experience that matches the importance of bringing the first early stage pre‐symptomatic ovarian cancer screening test to market."
Source: Arrayit Corp