About: Development History

An Idea is Born (June 1999)

During a social meeting, Peter J. Levine, now President and CEO of Correlogic Systems, Inc., and an FDA scientist, discuss the search for cancer biomarkers. Drawing on his experience in computer-generated data analysis, originally developed in connection with civil rights litigation, Levine suggests a radical idea—the use of pattern discovery technology to detect patterns of proteins rather than individual protein biomarkers. He literally sketches on a napkin the prospect of using powerful algorithms to search within the huge volume of data generated by new protein separation equipment for patterns of proteins in the blood.

Refining the Idea (July 1999 - May 2000)

Dr. Ben Hitt, now Chief Scientist Emeritus of Correlogic Systems, Inc., refines the concept and develops a powerful algorithm to test the theory that "hidden" patterns of proteins could be analyzed to detect early stage disease. In May 2000, using blood (sera) from prostate cancer patients, they conclude that this algorithm makes it possible to accurately perform a diagnostic assessment based upon patterns of proteins. Extension of this approach to research on ovarian and breast cancers as well as other disease states is initiated.

Correlogic Systems, Inc. Founded (May 2000)

Levine and Hitt found Correlogic Systems, Inc. to further develop the technologies regarding the identification and use of "hidden" protein patterns as a diagnostic tool. The company also enters into a Material Transfer Agreement with the FDA to continue its research.

Patent Applications Filed (June 2000 - July 2001)

In June 2000, Correlogic files a provisional patent application on the core algorithm used in the company's research work. Hitt is named as the sole inventor of the technology, referred to as the Knowledge Discovery Engine^®. In July 2000, Correlogic files the first of several provisional patent applications on a "Process for Discriminating Between Biological States Based Upon Hidden Patterns From Biological Data." The filing process for the patents is completed in July 2001.

The Lancet Fast-Track Publishes Ovarian Cancer Study (February 2002)

The Lancet "fast track" publishes results of a groundbreaking study utilizing Correlogic's techniques and technology, which showed that ovarian cancer can be detected from a single drop of blood, even in Stage One when the cancer is organ confined and most curable. The study demonstrates that the test can identify 100 percent of the patients with cancer. Co-authors of the study are Hitt, Levine, Liotta, Petricoin and others.

Formal Research Agreement Signed with FDA/NCI (April 2002)

Correlogic and the FDA/NCI Clinical Proteomics Program enter into a Cooperative Research and Development Agreement (CRADA). Work under the CRADA will further validate and expand the joint research that has begun on the early detection of ovarian, prostate, breast, and other cancers and will investigate application of the same technique to drug toxicity, drug metabolism, prion diseases and viral agents.

Exclusive License Agreement (April 2002)

To move the technology from the research lab into the hands of health care providers as soon as possible, Correlogic signs an exclusive, worldwide licensing agreement with NIH (on behalf of the FDA and NCI) for the shared "hidden patterns" invention. The license provides for the commercialization of the intellectual property rights associated with the use of patterns of molecular expression as a diagnostic tool. The license also provides for sub-licensing, joint venture and other business arrangements with various organizations and, importantly, will facilitate the rapid commercialization of the technology and development of clinical diagnostic tests.

Congressional Resolution Approved (July 2002)

On July 22, 2002, the U.S. House of Representatives approves H. Con. Res. 385. The Resolution, introduced by Rep. Steve Israel (NY) and Rep. Rosa DeLauro (CT), expresses the sense of Congress that the Department of Health and Human Services conduct and support research on Correlogic’s approach to screen for ovarian cancer, and that Federal and private health care plans cover the tests if demonstrated to be effective. By the date of passage, 147 Members had joined as co-sponsors.

Research Agreement with Johns Hopkins University (August 2002)

Correlogic and Johns Hopkins University enter into a collaborative research agreement to develop computational diagnostic models of inflammatory vascular diseases. Using Correlogic's proprietary software and processes, researchers will attempt to identify patients with specific inflammatory diseases by analyzing patterns of proteins found in their blood. This project extends the application of Correlogic's approach and technology to disease states other than cancer.

Journal of the National Cancer Institute Publication of Correlogic's Prostate Cancer Research (October 2002)

Correlogic, along with researchers from the FDA/NCI and the University of North Carolina Lineberger Comprehensive Cancer Center, successfully applied Correlogic's pattern discovery concept and technology to the early detection of prostate cancer. The research provides further validation that the protein pattern approach is effective in cancer and other disease detection. Their findings are published in the October 16, 2002 issue of the peer-reviewed Journal of the National Cancer Institute.

Correlogic Signs Licensing Agreement with Quest Diagnostics and LabCorp^® (November 2002)

Correlogic announces that it signed agreements with Quest Diagnostics Incorporated and LabCorp licensing the application of Correlogic's technology to ovarian cancer detection. The partnership with the nation's two premier clinical diagnostic labs combines Correlogic’s breakthrough technology with the proven expertise of Quest Diagnostics and LabCorp in introducing and performing large-scale sophisticated diagnostic testing. Together the three companies are positioned to make the potentially lifesaving ovarian cancer test available to women across North America.

Announcement of Further Enhanced Results (April 2003)

NCI announces in a press release on April 9, and again formally in a paper presented at the July 2003 conference of the American Association of Cancer Research, that working together, Correlogic, NCI and FDA scientists achieved further improved results in the detection of ovarian cancer. The team again used the Correlogic/NCI/FDA approach to ovarian cancer diagnosis and Correlogic’s pattern discovery technology, and utilized Correlogic’s enhancements in pre-computational components of the process.

Announcement of Research with Advion BioSciences (May/June/August 2003)

Correlogic Systems, Inc., and Advion BioSciences, a leading provider of mass spectrometry services and products, enter into an agreement to explore the use of Advion's NanoMate™ System as a component in Correlogic's ovarian cancer detection test. The companies jointly present data at both the American Society for Mass Spectrometry conference (June 2003, Montreal) and the CHI Protein Biomarkers conference (August 2003, Philadelphia) demonstrating the effective use of Correlogic's technology and procedures with the Advion NanoMate System.

Cancer Cell Publishes Pancreatic Cancer Research Paper (December 2003)

The peer-reviewed journal Cancer Cell, publishes "Preinvasive and invasive ductal pancreatic cancer and its early detection in the mouse", a paper co-authored by Correlogic's Chief Science Officer, Ben Hitt, along with researchers at NCI/FDA and others. This study, using mouse models, utilized Correlogic's technology to detect pancreatic cancer. It was a demonstration of the applicability of our technology to another cancer—one in which the disease’s typically rapid progression makes early detection particularly important.

Agreement with Mitsui & Co., Ltd. (February 2004)

Mitsui & Co., Ltd., Tokyo, Japan and Correlogic agree to explore the creation of a Japan-based joint venture for the deployment of Correlogic's diagnostic testing technology in Japan. Mitsui, headquartered in Tokyo, and among the world's largest multinational corporations, makes an equity investment in Correlogic.

Poster Presentation at the Society of Gynecologic Investigation Conference (March 2004)

Correlogic's poster "High resolution multidimensional mass spectrometry analysis for the detection of early stage epithelial ovarian cancer: a serum test for ovarian cancer" is presented at the Society of Gynecologic Investigation conference in Houston, TX on March 25, 2004. The poster shows results that were 97 percent sensitive and 94 percent specific in validation.

Toxicologic Pathology Publishes Cardiotoxicity Study (March/April 2004)

The peer-reviewed journal Toxicologic Pathology, publishes "Toxicoproteomics: Serum Proteomic Pattern Diagnostics for Early Detection of Drug Induced Cardiac Toxicities and Cardioprotection" a paper co-authored by Correlogic’s Chief Science officer Ben Hitt, researchers at the NCI/FDA, and others.  This research is the first application of Correlogic’s pattern recognition approach and technology to drug toxicity -- a significant issue in disease treatment.  Scientists identified patterns in mass spectra from sera that could identify rats treated with the cardiotoxic drug doxorubicin alone from those treated with doxorubicin and a cardioprotectant.  These results suggest that, using Correlogic's technologies, such toxicities may be detectable before adverse effects become irreversible.

Creation of OvaCheck^® Medical Advisory Panel (April 2004)

The OvaCheck Medical Advisory Panel is established to provide ongoing guidance to Correlogic in the final development of OvaCheck^®, and in its introduction to the medical and patient communities. The panel is comprised of pre-eminent medical clinicians and researchers in gynecologic oncology, and is chaired by one of the nation’s foremost authorities in gynecologic cancer, Philip J. DiSaia, M.D. The panel will review the test validation process and provide recommendations for clinical use, including guidance on appropriate patient populations, frequency of testing, and interpretation of results, and help present OvaCheck to the medical societies and other organizations.

Correlogic and Windber Research Institute to Collaborate on Breast Cancer Research (April 2004)

Correlogic Systems, Inc. and the Windber Research Institute sign a Material Transfer and Collaboration Agreement on breast cancer research.  The three-year collaboration joins scientists from Correlogic, and the Clinical Breast Care Project (CBCP) of the Walter Reed Army Medical Center, and Landstuhl Regional Medical Center in research focused on the development of a blood test for the early detection of breast cancer.  The research will apply Correlogic’s Proteome Quest^® pattern recognition technology to blood samples collected both retrospectively and prospectively from approximately 2,000 breast cancer patients and women with normal or benign breast pathology. 

Endocrine-Related Cancer Publishes Ovarian Cancer Research Paper (June 2004)

The peer-reviewed journal Endocrine-Related Cancer, publishes "High-Resolution Serum Proteomic Features for Ovarian Cancer Detection", a paper co-authored by Correlogic's Chief Science Officer, Ben Hitt, along with researchers at NCI/FDA and others. This research, including the continued use of Correlogic's technology, was a further extension our previously reported ovarian cancer results.

Collaboration with North Shore - Long Island Jewish (LIJ) (June 2004)

Correlogic and the North Shore - LIJ Research Institute enter into a collaboration to advance the final development of OvaCheck. With contributions from the Lynne Cohen Foundation and Row for the Cure, North Shore LIJ will collect blood samples from several hundred women to expand Correlogic's validation of the test, and to provide additional information to extend clinical application of the test.

Congressional Testimony (June 2004)

Peter Levine was called to testify before the House Energy and Commerce Committee’s Oversight and Investigations Subcommittee as part of the Subcommittee's series of hearings relating to conflicts of interest among NIH scientists. Correlogic’s experience in working with government scientists was the focus of nearly two full days of hearings and the catalyst for sweeping reforms within NIH.

Journal of Urology Publishes Further Prostate Cancer Research (October 2004)

The peer-reviewed Journal of Urology publishes "Serum Proteomic Profiling Can Discriminate Prostate Cancer From Benign Prostates In Men With Total Prostate Specific Antigen Levels Between 2.5 and 15.0 NG/ML.", co-authored by Correlogic, FDA, NCI and other scientists. The study applies Correlogic's technology to the serum of men with elevated PSA, and successfully discriminated between men with benign processes and men with prostate cancer, including men with PSA within the diagnostic gray zone.

Collaboration with University of Southern California/Norris Cancer Center (December 2004)

The Norris Cancer Center will collect blood samples from 700 women undergoing surgery, as part of the continuing validation of OvaCheck.

Arthritis and Rheumatism Publishes Wegener’s Disease Paper (March 2005)

The peer-reviewed journal, Arthritis and Rheumatism publishes the results of Correlogic’s research applying Correlogic’s hidden patterns approach and pattern recognition and discovery technology to Wegener’s disease. Together with Johns Hopkins University School of Medicine scientists and others, we successfully distinguished active disease from remission – which can enable physicians to better calibrate the use of powerful immunosuppressive drug therapy. This is the first application of our technology to detection of non-cancer disease.

Research Collaboration with University of Alabama (March 2005)

Correlogic announces it has entered into a collaboration with the University of Alabama at Birmingham as part of further validation of OvaCheck.  The UAB collection is headed by Ronald Alvarez, MD, Professor of Gynecologic Oncology and will provide serum samples from up to 250 patients undergoing gynecologic surgery. 

Correlogic Begins Prostate Cancer Collaboration with Uniformed Services University and Henry M. Jackson Foundation (May 2005)

Correlogic announces on May 3 a research collaboration with the Uniformed Services University of the Health Sciences (USU) and the Henry M. Jackson Foundation for the Advancement of Military Medicine.  The USU’s Center for Prostate Disease Research (CPDR) and the Foundation join Correlogic in two concurrent studies involving up to 2,000 men with specified prostate cancer conditions.  The first study will expand Correlogic’s research on the use of its “hidden patterns” approach and ProteomeDx^® pattern recognition technology to the detection of prostate cancer.  The second study will examine whether Correlogic’s approach and technology can be extended to distinguish between indolent and aggressive prostate cancer.  The goal is to develop blood tests that will improve the detection of prostate cancer, and help determine appropriate treatment.

Poster Presentation of Breast Cancer Research (May 2005)

At the annual meeting of the American Society of Clinical Oncologists (ASCO), Correlogic makes its first major presentation of the results of its ongoing breast cancer research with the Clinical Breast Care Project of Walter Reed Army Medical Center.  Our poster, “A Serum Pattern Predictive of Breast Cancer“, outlines progress in developing a diagnostic blood test for breast cancer.  Using sera from 371 women with normal or benign breast conditions and sera from 234 women with invasive cancer, we generated a model that demonstrated 80.5 percent sensitivity and 94.4 percent specificity.

Endocrine-Related Cancer Publishes Pheochromocytoma Study (June 2005)

In June 2005, the peer-reviewed journal Endocrine-Related Cancer, published "Low molecular weight proteomic information distinguishes metastatic from benign pheochromocytoma," a paper co-authored by Correlogic’s Chief Science officer Ben Hitt, researchers at the NCI/FDA, the Institute of Child Health and Human Development, and others.  This study, based on the use of Correlogic’s pattern recognition approach and technology, demonstrated the applicability of pattern discovery and recognition to differential diagnosis of malignant and benign disease. Researchers were able to identify combinations of low molecular weight molecules that could distinguish 100 percent of metastatic pheochromocytomas from benign cases in a blinded validation set.   Currently there is no reliable way to detect or predict which patients are at risk for metastatic pheochromocytoma.

Correlogic Receives Equity Investment from Quest Diagnostics, Inc. (June 2005)

Correlogic announces that it has received an equity investment from Quest Diagnostics, the largest provider of diagnostic testing, information and services in the U.S.  The agreement also provides Quest Diagnostics an option to commercialize specified diagnostic tests Correlogic is currently developing.

U.S. Patent and Trademark Office Grants “Hidden Patterns” Patent (August 2005)

The U.S. Patent and Trademark Office grants patent protection to A Process for Distinguishing between Biological States Based on Hidden Patterns from Biological Data (“Hidden Patterns”).  “Hidden Patterns” -- a process for using pattern recognition technology to evaluate subtle patterns of molecular changes in a patient’s body -- is at the center of Correlogic’s blood tests for the early detection of various cancers and other diseases.  The patent grants broad protection to the spectrum of biological applications, including disease detection, drug efficacy and toxicity, staging, prognosis and others.       

Analytical Chemistry Publication (September 2005)

The September 2005 issue of the peer-reviewed journal Analytical Chemistry publishes “Species-Specific Bacteria Identification Using Differential Mobility Spectrometry and Bioinformatics Pattern Recognition”. Correlogic’s Dr. Brian Mansfield is a co-first author; Drs. Ben Hitt and Ping Yip are also co-authors of the paper. The collaboration involved Charles Stark Draper Labs, Massachusetts General Hospital and others. Scientists used Correlogic's “Hidden Patterns” and Proteome Quest technology, to identify and differentiate between live bacteria based on analysis of the gases given off by the growing bacterial cultures.  The results have implications for diagnosis of bacterial infections using breath analysis. Other applications may include detection and identification of microbial growth in building materials and veterinary uses.

Spore Detection Research (March/June 2006)

There is urgent need for tools to detect bio-warfare agents with high specificity. Correlogic's scientists and colleagues from the Charles Stark Draper Laboratory and Tufts University School of Medicine used pyrolysis-micromachined differential mobility spectrometry (DMS) and Correlogic's genetic algorithms to distinguish among bacillus species closely related to Bacillus anthracis (the causative agent in anthrax).  Results showed over 90 percent accuracy with a sensitivity of detection of 5,000 spores, significantly below the median infectious dose of 8,000 to 10,0000 spores and the median lethal dose of ~62,000 spores.  Few existing rapid detection techniques detect below 100,000 spores.  Our research, “Novel technology for rapid species-specific detection of Bacillus spores” was published in the June 2006 issue of the peer-reviewed journal, Biomolecular Engineering.  Our research was also presented as a poster at the Pittcon Homeland Security and Forensics session, March 2006.

Experimental Hematology Publishes GVHD Research (June 2006)

Rapid rejection of transplanted tissue is a life-threatening complication of tissue transplantation and current tests are time-consuming and invasive. Our research, "Accurate diagnosis of acute graft-versus-host disease using serum proteomic pattern analysis" suggests the potential application of our technology as a rapid and accurate method to diagnose acute GVHD. Note: this study presents data generated several years ago. Correlogic's technology platform is now based on high-resolution, orthogonal time-of-flight mass spectrometry. This research was conducted under a CRADA with the FDA and NCI, which concluded in 2004.

U.S. Patent and Trademark Office Grants KDE Patent (August 2006)

On August 22, 2006 the U.S. Patent and Trademark office issued a patent to Correlogic entitled A Heuristic Method of Classification.  The invention encompasses heuristic algorithms for the classification of objects, and is commonly referred to as the Knowledge Discovery Engine^®, or KDE^™; it is the key element in the company’s software suite, Proteome Quest^®, which is used to build biologic state computer models. The patent also covers a wide range of non-biological applications, providing a robust foundation for its eventual use outside of clinical diagnostics.

Additional Mitsui Investment and Research Collaboration (October 2006)

Mitsui & Company, Ltd. made a second tranche investment in Correlogic and entered into a research collaboration with Correlogic for the clinical development of diagnostic tests for use in Japan.  Tests will be for the detection of ovarian and other cancers, including cancers with particular prevalence in Japan.  The agreement reflects Correlogic’s successful completion of the “mini-trial” that followed Mitsui’s initial investment in February 2004.

Correlogic and JEOL Sign R&D Agreement (June 2007)

Correlogic and JEOL, Ltd. announced a research and development agreement to further enhance the performance of mass spectrometry in a clinical setting. JEOL, based in Tokyo, Japan is a leading manufacturer of scientific instruments for research and development in nanotechnology, life sciences, optical communication, forensics, and biotechnology. This agreement formalizes and extends the ongoing collaboration between the companies.

U.S. Patent and Trademark Office Grants Additional KDE Patent (July 2007)

On July 3, 2007, the U.S. Patent and Trademark office issued a patent to Correlogic entitled "Heuristic Method of Classification" (U.S. 7,240,038). This is a continuation of a prior patent awarded to Correlogic in 2006 (U.S. 7,096,206). The invention described in both patents relates to algorithms that can be used to discover patterns in complex data sets for diagnostic and other purposes.

U.S. Patent and Trademark Office Grants Three Quality Assurance Patents (February 2008/July 2008)

The U.S. Patent and Trademark Office granted Correlogic two patents on February 19, and a third patent on July 1, 2008, relating to quality assurance methods for analysis of blood samples in diagnostic assays. U.S. Patent No. 7,333,895 covers various methods to assure that the results of a biological assay are reliable. U.S. Patent No. 7,333,896 covers other quality control methods including a determination as to whether blood serum samples have been handled in a manner acceptable for analysis by mass spectrometry, and methods to certify that biochips used for analytical purposes meet appropriate quality control standards. U.S. Patent Number 7,395,160 covers essential quality control methods to help ensure the validity of test results when blood serum is analyzed on a mass spectrometer.

OvaCheck^® - Ovarian Cancer Blood Test

OvaCheck, a blood test for the early detection of ovarian cancer, is the first diagnostic test using Correlogic's approach and technology.  Following resolution of FDA regulatory matters, the test will be available nationwide.

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