- 93% Diagnostic Accuracy and 99% Specificity Support Implementation of the CGI Kidney Cancer Algorithm and Test in A Clinical Setting
- New Data Presented at USCAP Annual Meeting; 188 Patient Study Conducted in Conjunction with Cleveland Clinic
RUTHERFORD, N.J. and SAN DIEGO, March 5, 2014 (GLOBE NEWSWIRE) -- Cancer Genetics, Inc. (Nasdaq:CGIX) ("CGI") announced today the results of a collaborative study conducted with The Cleveland Clinic to validate CGI's kidney cancer microarray test. The CGI kidney cancer microarray facilitates the diagnosis, sub-typing, and outcome prediction of kidney cancer patients. This study demonstrated that the diagnostic sensitivity of the test is 93%, with 99% specificity. The clinical validation study was performed using samples from 188 kidney cancer patients treated at the Cleveland Clinic. Accurately diagnosing kidney cancer using pathology alone is challenging, and can delay time to first treatment if surgical resections are required.
Cancer Genetics is currently commercializing the test nationally by making it available as laboratory developed test (LDT). This study and final data were presented this week by Dr. Magi-Galluzzi of the Cleveland Clinic at a podium presentation at the 2014 United States & Canadian Academy of Pathology (USCAP) annual meeting in San Diego. These results provide additional evidence to support the clinical value of CGI's, unique, disease-focused, genomic tests.
This study and data follows the company's recent notice of allowance for an additional patent in methods for detecting the subtype of rental cortical neoplasms announced last week.
"This compelling study with Cleveland Clinic, along with initial work with Memorial Sloan Kettering, provides significant evidence that our technology has unparalleled value as a breakthrough diagnostic for kidney cancer," stated Panna Sharma, CEO of Cancer Genetics. "These new data come at an opportune time, since March is Kidney Cancer Awareness month, and our test has the ability to both subtype and help predict outcome from a small amount of DNA taken from either paraffin-embedded or fine needle aspirate. This is very unique and will be a tremendous aid for both pathologists and oncologists helping patients in the battle against kidney cancer."
The study, "Evaluation of a decision tree in the diagnosis of renal neoplasms based on genomic aberrations detected by array-CGH," was completed in conjunction with a translational team at the Cleveland Clinic that included both Pathology and Laboratory Medicine and The Urological Institute. The study reviewed 15 targeted genomic regions for copy number data across 188 samples. The study included samples from all major subtypes of renal cancer. The samples were initially selected for the study based on pathologic diagnosis: 62 clear cell carcinomas, 56 papillary carcinomas, 34 chromophobe carcinomas, and 36 oncocytomas.
Highlights of the analysis include:
- Only 2 micrograms (µg) of DNA material was needed for the test.
- Overall tumor subtyping ranged from 97% diagnostic accuracy for clear cell, 93% for chromophobe, 91% of papillary and 86% in oncocytomas.
- 173 of the 188 samples were correctly assigned to a tumor subtype.
- Specificity of the molecular diagnosis using the array ranged from 100% for chromophobe; 99% for oncocytoma and 97% for both clear cell and papillary kidney cancer subtypes.
- The results support implementation in a clinical setting to provide highly accurate subtyping and outcome prediction for renal cancers.
- The panel is also being transferred to a Next-Generation Sequencing (NGS) platform for additional assessment of genomic aberrations.
Over 60,000 new cases of kidney cancer are detected each year in the U.S. and approximately 14,000 deaths occur, making more accurate diagnosis and earlier time to treatment critical in managing the disease. It is estimated that 200,000 to 240,000 cases require assessment annually for kidney cancer. Kidney cancer is among the 10 most common cancers in both men and women.
The 103rd annual USCAP meeting, taking place this week at the San Diego Convention Center, San Diego, CA, is the world's largest pathology meeting.
About Cancer Genetics:
Cancer Genetics, Inc. is an emerging leader in DNA-based cancer diagnostics, servicing some of the most prestigious medical institutions in the world. Our tests target cancers that are difficult to diagnose and predict treatment outcomes. These cancers include hematological, urogenital and HPV-associated cancers. We also offer a comprehensive range of non-proprietary oncology-focused tests and laboratory services that provide critical genomic information to healthcare professionals, as well as biopharma and biotech companies. Our state-of-the-art reference lab is focused entirely on maintaining clinical excellence and is both CLIA certified and CAP accredited and has licensure from several states including New York State. We have established strong research collaborations with major cancer centers such as Memorial Sloan-Kettering, The Cleveland Clinic, Mayo Clinic and the National Cancer Institute. For further information, please see www.cancergenetics.com.
Forward Looking Statements:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development and potential opportunities for Cancer Genetics, Inc. products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to, statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, risks of cancellation of customer contracts or discontinuance of trials, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, maintenance of intellectual property rights and other risks discussed in the Company's Form 10-Q for the quarter ended September 30, 2013 and other filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof. Cancer Genetics disclaims any obligation to update these forward-looking statements.
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