Mission
OTraces, Inc. has combined two highly innovative technology developments to produce practical specific and sensitive screening blood tests for cancer for the first time, including Breast, Ovarian, Prostate, Lung and other cancers. First, a new ultra-sensitive protein detection technology has been developed that is several hundred times more sensitive than current methods. Next, a novel approach has been developed for evaluating potential biomarkers for Screening Diagnostic Oncology that depends on the ultrasensitive detection technology to quantify “Low Abundance Proteins“(LAPs) critical to the diagnosis. As a result, the new OTraces blood tests are both highly sensitive and specific, (>95%). This level of performance far exceeds any current non-invasive diagnostic method for cancer. Over 830 women for Breast Cancer and 260 men for Prostate Cancer have been evaluated with OTraces’ test with results noted above.
Clinical Status
Concerning breast cancer, OTraces management believes that data already obtained are sufficient for the preclinical stage of the regulatory submission process, and are sufficient to minimize risks in the actual in clinic trials. Beyond this OTraces has completed a clinical protocol for this cancer based upon evaluating premenopausal women who present with a lump and are judged to be uncertain by imaging methods. This protocol is in final review and will be submitted to the FDA in the first quarter 2009. Three beta sites will be needed for the formal and blind third party trials. These sites are indentified, University of Maryland, Baltimore, University of Pennsylvania, Philadelphia, and Duke University. The sites on board have supplied all of the serum samples and correlating information (mammography, MRI and biopsy) for the preclinical testing, and are keen to move this important improvement in diagnostic oncology screening forward.
Breast Cancer Data
For a sample size of 734 women (580 with BC and 154 healthy) the test sensitivity and specificity far exceeds all current methods. Clinical samples, were supplied by Charite’ University of Medicine, Berlin and The University of Pennsylvania Hospital Center, Philadelphia, as well as I. Curie, Paris. France.
Table 1. Blood-based Breast Cancer Detection Using Proprietary Method
Patient Cohort |
Correct |
Uncertain |
False |
Breast Cancer (n=495) |
97.0% |
0.6% |
2.4% |
Healthy women (n=373) |
97.1% |
0.0% |
2.9% |