Research Areas: OvaCheck^® FAQs

How is OvaCheck different from other blood tests?

OvaCheck is based on the cutting edge science of proteomics/metabolomics — the study of proteins, protein fragments and metabolites.  Unlike conventional tests, such as CA-125, that measure the increase of individual proteins in the blood, OvaCheck looks for subtle changes in patterns among the tens of thousands of proteins, protein fragments and metabolites in the blood.  It then employs Correlogic’s artificial intelligence-based computer technology to identify these hidden patterns. 

Conventional tests that rely on the detection of a single protein or biomarker associated with a disease are often ineffective in detecting early stage disease because the increase in these biomarkers may not occur or be detectable until the disease is more advanced.  But OvaCheck is based on the principle that subtle patterns of change occur in early stage ovarian cancer.  OvaCheck can be used to detect those proteomic pattern changes. 

How accurate is OvaCheck?

In research studies, the underlying “Hidden Patterns” approach and pattern recognition technology that are used in OvaCheck have been shown to be highly accurate in detecting ovarian cancer and other diseases.

Although in some studies, the combined approach and technology showed 100 percent sensitivity and specificity — no false negatives or false positives — results that are produced from a relatively small number of samples examined under very highly controlled research laboratory conditions are unlikely to be replicated in actual practice. 

The conventional Pap test is 75 percent sensitive in identifying cervical cancer; the more recent Thin Prep test is 82 percent. A 2005 New England Journal of Medicine study reports that the mammogram has only 41 percent overall sensitivity.

The final results for OvaCheck will be established shortly before the launch of the test.  It is expected that OvaCheck will produce results that are at least as sensitive and specific as tests that are accepted medical practice for other diseases.  

 When will OvaCheck be available?

Correlogic is currently in discussions with the Food and Drug Administration concerning the scope of the regulatory submission the agency will require. The scope of this review is the key determinant of when the test will be available. 

Based on precedent, experts expected OvaCheck could be offered as a laboratory developed test, regulated under the Clinical Laboratory Improvement Act (CLIA).  However, in a departure from previous practice, the FDA indicated its intention to exercise regulatory authority in this area.  FDA subsequently issued draft regulatory guidance asserting authority over In Vitro Diagnostic Multivariate Index Assays more broadly. 

A regulatory submission to FDA that is based on large-scale prospective clinical trials requires many months of additional sample/data collection.  Correlogic is currently conducting clinical trials in an effort to be far along toward meeting the FDA requirements, once agreement on the scope of FDA’s demands is reached.

Background on Laboratory Developed Tests

Unlike pharmaceuticals, or diagnostic tests that are packed and sold as kits, laboratory developed tests do not necessarily require prior FDA approval.  Such tests may be regulated instead under the Clinical Laboratories Improvement Act. 

Currently there are over 1,000 laboratory developed tests on the market, including many common or familiar tests, such as the test for cystic fibrosis, offered to all pregnant women in the U.S., the tests for Lyme disease, herpes and SARS.  Laboratory developed tests often represent cutting edge technology, as this regulatory avenue allows vital new technology more rapidly to reach patients.  The overwhelming majority of the more than 300 molecular and genetic assays on the market are, or were introduced, as laboratory developed tests. 

Often, tests are introduced as a laboratory developed test while the FDA process proceeds as FDA approval can help a test gain broader medical acceptance and insurance coverage. The Thin Prep Pap test is a prominent example of a test that began as a laboratory developed test, and subsequently obtained FDA approval.  Manufacturers were able to get this test to physicians and their patients, while seeking FDA approval on a parallel track.

Similarly, Correlogic and its lab partners expected that OvaCheck would be submitted for FDA approval in the future.  In the meantime, women who needed OvaCheck would have access to it.  This approach was considered especially important in view of the critical importance of early detection and the limits of existing tools. 

What is the relationship of OvaCheck to NCI and FDA research?

Research on OvaCheck’s underlying approach and technology was conducted in collaboration with the National Cancer Institute (NCI) and the FDA.  Working under a Cooperative Research and Development Agreement (CRADA), Correlogic and government scientists explored the hidden patterns approach and utilized Correlogic's proprietary technology to identify patterns of protein expression indicative of specific diseases.  Their ground-breaking research was first published in the February 16, 2002 issue of the peer-reviewed medical journal, The Lancet. This study showed the combined “Hidden Patterns” approach and Correlogic’s technology to be highly accurate in detecting ovarian cancer — even in stage one, when the disease is most treatable.  

The Correlogic/FDA/NCI team of scientists, working together, conducted a total of seven studies that have been published in peer-reviewed journals — each using Correlogic’s Hidden Patterns approach and Proteome Quest^® technology to detect various disease states.  The results of their most recent ovarian cancer study appeared in the June 2, 2004 publication of the journal Endocrine-Related Cancer.  The team also made a scientific poster presentation, and government scientists have used the Correlogic approach and technology as the basis for additional peer-reviewed publications and scientific presentations.  (The most recent publication of research conducted under this collaboration – on GVMD — was submitted in 2005, year after completion of the CRADA, and published in the June 2006 issue of Experimental Hematology.)

Our collaboration with government researchers was the foundation for OvaCheck.  The initial Lancet study first demonstrated the concept of using hidden patterns to detect disease.  Subsequent studies conducted with government researchers have extended and refined this work.  And FDA/NCI scientists heading the government’s team in this collaboration have represented the work as follows:

…Correlogic is working with Quest and LabCorp to initiate this procedure as a homebrew [laboratory developed] test for ovarian cancer.  Methodology and procedures developed with Correlogic in our laboratory under our CRADA will be used by both Quest and LabCorp as a lead embodiment launch point for their test.  We think this will translate into maximum public benefit under scientific rigor as quickly as possible. 

The government is not involved in the current development, validation or marketing of the actual OvaCheck test. Subsequent to the conclusion of our CRADA work with the government, Correlogic advanced its research, including enhancements in sample handling, sample preparation, sample ionization and other components of the actual tests that will be available to detect ovarian cancer and other diseases.  

How can women participate in the OvaCheck trials?

Twelve medical institutions, in the U.S. and abroad, are participating in research on OvaCheck. These institutions, using Correlogic’s strict protocols, are collecting blood samples from enrolled patients.  The collections will provide important information that can further enhance the OvaCheck test and support submissions for regulatory, insurance and medical society approval.    

There are several eligibility requirements for patients.  In general, we are seeking participation from women who are scheduled to undergo certain gynecologic surgeries.  The surgery must take place at one of the medical institutions participating in this research.  Women enrolled in the studies are asked to provide a blood sample prior to surgery.

Patient information as well as any results will remain entirely anonymous; Correlogic will not have access to patient identifiers, and the research will not convey results to patients.  This research will not affect the course of the patient’s treatment, but it will contribute importantly to the advancement of this test.  We are grateful to the many hundreds of women who have already contributed.

For further information, please contact info@correlogic.com