Medical Device Link.

Originally Published IVD Technology April 2004

INDUSTRY NEWS

It is reminiscent of last summer’s halt in the release of Roche’s Amplichip technology to the clinical market—the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD; Rockville, MD) has requested to meet with an IVD manufacturer to discuss the regulatory classification and requirements of its test before the manufacturer releases the test as a homebrew. 

Ovacheck, a proteomics-based ovarian cancer test developed by Correlogic Systems (Bethesda, MD) and licensed to The Laboratory Corporation of America (Labcorp; Burlington, NC) and Quest Diagnostics (Teterboro, NJ) was initially expected to be put in use on April 1. However, less than a month before the planned release, Steven Gutman, director of OIVD, wrote, “[OIVD is] uncertain if [the Ovacheck] will be subject to regulation by CMS under the Clinical Laboratories Improvement Amendments of 1988, or whether it may also require premarket review by FDA under the Federal Food, Drug, and Cosmetic Act.”

FDA is hesitating to allow the test to be put on the market before it has been reviewed by the agency because there is some confusion as to whether the test should be considered a medical device or an analyte specific reagent. The test uses a proprietary software program to analyze mass-spectrometry-generated patterns of protein fragments in the blood.

The technology used in the Ovacheck test allows for a significant improvement over the current standard test for ovarian cancer, the cancer antigen 125 test (CA-125). The CA-125 test successfully detects ovarian cancer in 24% of cases, but the Ovacheck has been shown to do so in 94% of cases. 

In addition, the new test will likely be able to detect cancer in far earlier stages than the CA-125 test. Currently, 75% of ovarian cancer cases are caught in the advanced stages of the disease when the chance of surviving for five years or more is less than 15%. If the disease is caught in its earlier stages, the patient survival rate is boosted by 90%.

Peter Levine, president of Correlogic said, “Our test is unique in that it measures small, previously undetectable increases and decreases in a wide range of proteins. We hope [that it] will make the death rate drop dramatically.”

In his letter to Quest, Gutman said, “[OIVD] strive(s) to protect the public health without unnecessarily imposing regulatory burdens on the marketing of products of potential clinical importance.” Although the office is clearly attempting to protect public safety while furthering technological advancement, if the technology must undergo testing as a full IVD, several years may pass before this potentially life-saving technology becomes widely available to the public.

Copyright ©2004 IVD Technology