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Ovarian cancer test

This article was originally published in The Gray Sheet

Executive Summary

FDA cleared Vermillion Inc.'s OVA1 test Sept. 11 to help detect ovarian cancer in pelvic masses known to require surgery, allowing clinicians to determine the type of surgery needed. OVA1 is used as an adjunct to other procedures to determine if a pelvic tumor is malignant prior to biopsy or exploratory surgery, even when radiological tests fail to indicate malignancy, FDA and the firm say. OVA1 tests patient blood for levels of five proteins affected by ovarian cancer, and then combines the results into a numerical score between zero and 10 indicating whether the mass is benign or malignant. OVA1 is not intended for ovarian cancer screening or definitive diagnosis of cancer, FDA notes. Quest diagnostics has exclusive rights to market the test in the U.S. for three years. FDA pressured Quest-competitor LabCorp to stop marketing a similar "in vitro diagnostic multivariate assay"-style ovarian cancer test last October for not having the appropriate FDA clearance (1"The Gray Sheet" Oct. 27, 2008)

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Quest, Vermillion Begin U.S. Marketing Push For Ovarian Cancer Test

Quest Diagnostics will leverage its know-how of the women's health care segment and relationships with OB/GYNs to market Vermillion's OVA1, the first FDA-cleared blood test to help assess potentially malignant ovarian tumors prior to surgery

Financings In Brief

SurgiVision IPO seeks to raise $30 million: Magnetic resonance image-guided surgery system developer plans an initial public offering of up to $30 million of common stock to support further R&D. SurgiVision's technology "enables physicians to see inside the brain and heart using direct, intra-procedural [MRI] guidance while performing minimally invasive procedures," the company explains in a preliminary IPO prospectus recently filed with the Securities and Exchange Commission. Farthest along in the product pipeline is SurgiVison's ClearPoint neurological intervention system, designed for "linear, point-to-point, minimally invasive procedures performed in a standard 1.5T MRI suite," SurgiVision states. A 510(k) application for the device is currently pending at FDA. Also under development is the firm's ClearTrace cardiac intervention system for non-linear, catheter-based surgical procedures using a 3T MRI scanner; SurgiVision is collaborating with MRI scanner manufacturer Siemens on that project. Headquartered in Memphis, Tenn., SurgiVision is also working with Boston Scientific under its SafeLead program to incorporate MRI-safety technologies into the latter firm's implantable cardiac rhythm management and neuromodulation leads. Rodman & Renshaw is underwriter for the proposed IPO

LabCorp Pulls OvaSure, But Charges FDA With Overreaching

Laboratory Corporation of America pulled its early-stage ovarian cancer test service from the market last week in response to FDA scrutiny, but the lab giant called the agency's actions leading up to the withdrawal "unprecedented.

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