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OTraces-Diagnostic Proteomics – A New Approach-White Paper

OTraces, Inc. Issues White Paper:  New Approach to Diagnostic Proteomics

  • Use of Math- and Physics-Based Software to Boost Accuracy to Superior Levels
  • Uses Tumor Microenvironment (TME) to Enhance Diagnosis – An Industry First

OTraces has developed a cancer blood testing platform based on standard immunoassay-based instrument and reagent tests already widely deployed in the high volume IVD market, amplified by proprietary software, that has demonstrated accuracy of 90%+ (as measured by predictive power), and uses the tumor microenvironment (TME) as its principal focus, thus revealing potentially crucial diagnostic information that DNA or tumor markers alone do not possess.

Introduction to the White Paper

In recent years, cancer immunotherapy research has become increasingly interested in the tumor microenvironment (TME) which represents a potentially vast storehouse of diagnostic content. The TME, which is immersed in the tumor interstitial fluid (TIF) is the cellular environment in lymphocytes, signaling molecules and the extracellular matrix.

Although recognized as a potential source of rich diagnostic information, development of TIF analysis as a cancer screening modality has not progressed as sampling this fluid is very difficult and in order to do so means that the location of the tumor is known and therefore whether a tumor already exists.

In this white paper, we discuss a method for analyzing specific cytokines present in serum as an accurate proxy for the proteins active in the TME and TIF. The method involves several steps including two proprietary processes, termed proteomic noise suppression and multidimensional (or spatial) correlation.

The method we describe can yield an accurate proxy for the actions of the proteins found in the TIF and thus is useful for detecting the presence of an active TME within the organism and thus a tumor. In essence, this method isolates the signature of the TME in the serum and indicates the presence (or not) of an active TME, indicating that an active tumor is present. Beyond this, the method measures the modulation of these proteins, which yields valuable information about the status of the tumor, degree of aggressive action and stage, as well as information about the immune system’s progress in suppressing the tumor.

About OTraces, Inc.

Maryland-based OTraces, Inc. has developed a cancer blood testing platform based on standard immunoassay-based instrument and reagent tests already widely deployed in the high volume IVD market, amplified by proprietary software, that has demonstrated accuracy of 90%+ (as measured by predictive power), and uses the tumor microenvironment (TME) as its principal focus, thus revealing potentially crucial diagnostic information that DNA or tumor markers alone do not possess.

The OTraces platform incorporates cloud-based accuracy-enhancing software that uses patented math- and physics-based noise suppression algorithms never before employed used human disease testing.  The 90%+ predictive power performance record to date significantly exceeds the IVD industry average and all known competition including DNA-based liquid biopsy.

This performance has been demonstrated in validation trials for the company’s PR Sera DX test for prostate cancer currently being conducted at the Johns Hopkins University Medical Center as an expected pathway to Canadian and possibly U.S. clinical trials and for the company’s BC Sera DX breast cancer test being conducted at the Gertsen Institute in Moscow for an expected launch for that test in the Russian Federation later this year.

The OTraces is believed to be the only blood test modality that can access the diagnostic content of the tumor microenvironment (TME) — the cellular structures and fluids that surround the tumor that recent research has indicated is a vast storehouse of cancer information that far exceeds tumor markers or DNA alone.

OTraces uses FDA-compliant archival software and secure cloud-based transmissions for both the company’s prostate and breast cancer screening tests now in development and is available to any company and laboratory in the U.S. or internationally seeking to biomarker or test optimization through collaboration with OTraces, wherein online access to this software will be provided usually on either a fee-for-service or revenue-sharing basis.

OTraces Inc.

Dr. Richard Saul
(301) 325 6669
1500 Fannie Dorsey Rd. Sykesville, MD. 20797 P: (301) 529 3824/txt

 

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