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Quest Diagnostics Introduces BRCAvantage Plus, Providing New Choices in Genetic Breast Cancer Risk Testing

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced BRCAvantage Plus, the company’s first suite of lab-developed test services for assessing genetic breast cancer risk based on clinically validated non-BRCA as well as BRCA genes. The new service is now available in all 50 states.

Cancer Genetics, Inc. Selected By Gilead Sciences, Inc. to Provide Clinical Trial Services for International Trials in Chronic Lymphocytic Leukemia

Cancer Genetics, Inc. (CGI) announces that it has been chosen by Gilead Sciences Inc. (Gilead) to provide clinical trial services and molecular profiling of chronic lymphocytic leukemia (CLL) patients. The trials cover both national and international locations. CGI will leverage its SelectOne™ program that includes proprietary genomic assays in CLL, data and logistics management, and comprehensive CLIA- and CAP-accredited clinical laboratory testing. The ongoing studies consist of testing across several methodologies, including flow cytometry, FISH, and molecular diagnostics assays including mutational analyses of IGHV, TP53, NOTCH1, and CGI’s proprietary array-CGH assay for mature B-cell neoplasm, MatBA®-CLL/SLL.

Targeted therapies have the potential of improving the lives of cancer patients and providing them with better treatment outcome. CGI’s SelectOne™ offering empowers biotech and pharma companies like Gilead to achieve their goals in oncology clinical trials through the use of CGI’s comprehensive oncology focused menu and proprietary microarrays.

CGI expects the trials to continue for the next several years, and may potentially enable an expedited and more efficient development timeline based on improved patient stratification. CGI also offers comprehensive CLL testing to cancer centers, oncologists and community hospitals under its CLL CompleteSM offering. This includes the assessment of ZAP-70, CD38, mutational status of IGHV, TP53 and SF3B1, genomic alterations by FISH and by a proprietary genomic microarray – MatBA®-CLL/SLL which includes a comprehensive report stratifying the risk and potential outcome, to guide disease and patient management. CLL is a clinically heterogeneous disease and the most common form of leukemia in the Western Hemisphere. It is estimated that in the United States there is a new case diagnosed every forty minutes and there are over 110,000 people living with CLL.

Source: Cancer Genetics

Abbott to Collaborate with Janssen and Pharmacyclics on Development of Companion Test for Investigational Leukemia Therapy

Abbott (NYSE: ABT) recently announced that it will collaborate with Janssen Biotech, Inc. and Pharmacyclics, Inc. to explore the benefits of Abbott’s proprietary FISH (fluorescence in situ hybridization) technology for use in developing a molecular companion diagnostic test to identify patients with a genetic subtype of chronic lymphocytic leukemia (CLL), the most common form of adult leukemia.

Under the agreement, Abbott will develop a FISH-based test to identify high-risk CLL patients who have a deletion within a specific chromosome (chromosome 17p (del17p)) and may respond to ibrutinib, an oral, small molecule inhibitor of Bruton tyrosine kinase (BTK). Ibrutinib is currently in development by Janssen and Pharmacyclics for several B-cell malignancies, including chronic leukemia and lymphoma. Patients harboring a deletion within chromosome 17p are poor responders to chemoimmunotherapy and have limited treatment options. Having a test that is able to accurately detect the 17p deletion identifies a specific patient population with a high unmet medical need.

“Like Abbott’s other collaborations in the area of companion diagnostics, our goal is to leverage molecular technologies to help ensure that the right medicine is getting to the right person,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Cancer is a complex disease where, historically, therapies have demonstrated only a 25 percent efficacy rate. Companion diagnostic tests can help improve these outcomes by selecting patients that are more likely to respond to specific therapies, reducing time to the most effective treatment and increasing the number of positive outcomes.”

According to the American Society of Clinical Oncology (ASCO), future cancer therapies will be developed through molecular approaches that can accelerate development of more effective, personalized treatments. Identifying specific genetic characteristics of malignancies is expected to also support development of new treatments that target specific proteins involved in the development and growth of cancer.

In 2011, Abbott received U.S. Food and Drug Administration clearance for its Vysis CLL FISH Probe Kit. The kit targets multiple genes, including TP53 (tumor protein p53 gene, located on chromosome 17p) within the del17p region, and is used as an aid for determining prognosis for patients with CLL. Abbott’s Vysis CLL FISH Probe Kit will be used for investigational use only to determine genetic marker status as part of the co-development efforts between Janssen, Pharmacyclics and Abbott.

Source: Abbott

Research Study of Triple Negative Breast Cancer Highlights Ability of NextBio Clinical to Identify Biomarkers

The ability of NextBio Clinical to rapidly identify biomarkers and possible disease targets in an aggressive form of breast cancer was highlighted this week in a poster presentation at the American Society of Clinical Oncology’s 2012 Breast Cancer Symposium. NextBio Clinical was used to investigate a cohort of published patient data, curated by NextBio, for key differences between Triple Positive Breast Cancer (TPBC) and Triple Negative Breast Cancer (TNBC), a form of the disease that offers a worse prognosis for those diagnosed. Results of the study quickly identified several key differences in gene expression and methylation status between the two breast cancer types, as well as a novel biomarker and potential alternate way of treating TNBC.

Decoding DNA Finds Breast Tumor Signatures that Predict Treatment Response

Decoding the DNA of patients with advanced breast cancer has allowed scientists to identify distinct cancer “signatures” that could help predict which women are most likely to benefit from estrogen-lowering therapy, while sparing others from unnecessary treatment.