CGI diagnostics added to online test database

RUTHERFORD, N.J.—Cancer Genetics Inc. recently announced that several of its proprietary diagnostic and prognostic genomic tests are now available on the National Institutes of Health Genetic Testing Registry. As noted on the website, the GTR “provides a central location for voluntary submission of genetic test information by providers. The scope includes the test’s purpose, methodology, validity, evidence of the test’s usefulness and laboratory contacts and credentials. The overarching goal of the GTR is to advance the public health and research into the genetic basis of health and disease.” So far, according to the registry’s website, “GTR has over 16,000 detailed tests for 4,200 condition and 2,800 genes.”

“Having information about our tests widely available via an online database is crucial to ensuring patients, clinicians and healthcare providers have the information they need about our genomic cancer tests and panels,” Panna Sharma, CEO of Cancer Genetics, said in a news release. “We want to drive greater adoption of our proprietary tests for lymphomas and leukemias, kidney cancer and HPV-associated cancers. Participating in the Genetic Testing Registry helps us move towards this important objective.”

Cancer Genetics has 40 tests in the GTR listings, covering 24 conditions/phenotypes. Among those tests are FHACT, a FISH-based HPV-associated cancer test for cervical cancer that detects genomic abnormalities linked to progression to cancer; UroGenRA-Kidney, a CGH-microarray test for diagnosing and subtyping renal cell carcinoma; and MatBA, a panel for mature B-cell neoplasms that is currently available for chronic lymphocytic leukemia/small lymphocytic lymphoma, mantle cell lymphoma, diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma. Cancer Genetics announced on Sept. 2 that its FHACT in-vitro diagnostic received the CE mark, clearing it for marketing in the European Economic Area.

“We are very pleased to add Cancer Genetics Inc.’s test menu to GTR as part of our new offerings on cancer tests,” commented Dr. Wendy Rubinstein, director of the Genetic Testing Registry and senior scientist at the National Center for Biotechnology Information, a division of the National Library of Medicine at the National Institutes of Health. “Our goal is to improve transparency surrounding genetic and genomic tests and to improve access to information for healthcare providers, researchers and others. Cancer Genetics is an early adopter among laboratories offering testing for malignancies, and their data submission helps us achieve these goals.”

In other recent diagnostic news for the company, Cancer Genetics announced on Sept. 23 that it had begun a collaboration with Beth Israel Deaconess Medical Center to investigate genomic biomarkers in patients with DLBCL and use an integrated approach to determine how they are associated with patient outcomes. Together, the organizations plan to examine approximately 200 DLBCL tumors from patients who previously received treatment with current frontline immunotherapeutic regimens, looking at biomarkers such as genomic rearrangements, copy number changes and mutations.

This follows an August announcement of a similar partnership—Cancer Genetics shared news on Aug. 25 of a collaboration with Keck School of Medicine of the University of Southern California pathologist Dr. Imran Siddiqi for the identification and evaluation of genomic markers for the prognosis of DLBCL. The collaboration will make use of Cancer Genetics’ proprietary MatBA-DLBCL test, which can provide a prognosis for DLBCL patients based on genomic copy number changes. Along with Siddiqi, an assistant professor of clinical pathology at Keck School of Medicine, the company will seek to further identify and evaluate unique genomic copy number changes that could serve as additional prognostic markers in this cancer subtype. No financial details were disclosed.