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QIAGEN and Lilly Collaborate to Co-Develop Companion Diagnostics for Simultaneous Analysis of DNA and RNA Biomarkers in Common Cancers

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced a collaboration with Eli Lilly and Company (NYSE: LLY) to co-develop universal and modular assay panels for the simultaneous analysis of DNA and RNA biomarkers targeting multiple cellular pathways involved in common cancer types. The agreement includes the development of tests that will be based on QIAGEN’s multi-modal, multi-analyte Modaplex analysis platform, which can process multiple sample types and biomarkers in a single test.

Thought Leaders are Optimistic that Emerging Therapies will Offer Efficacy Benefits Over Current Therapies for Metastatic Gastric Cancer; Augmenting Biomarker-Driven Prescribing

Decision Resources Group finds that interviewed oncologists’ are optimistic that emerging targeted therapies will offer efficacy advantages over current treatment options for metastatic gastric cancer. Physicians anticipate that Roche/Genentech/Chugai’s Perjeta and Roche/Genentech/Chugai’s Kadcyla will join Roche/Genentech/Chugai’s Herceptin in the HER2-targeted treatment armamentarium for metastatic gastric cancer. Moreover, oncologists express enthusiasm for c-Met overexpression as a predictive biomarker in metastatic gastric cancer, and anticipate that rilotumumab (Amgen/Astellas Pharma) and onartuzumab (Roche/Genentech/Chugai), both in combination with chemotherapy, will demonstrate efficacy advantages over chemotherapy alone. Interviewed physicians also expressed enthusiasm for the angiogenesis inhibitor ramucirumab (Eli Lilly/ImClone Systems), based on positive Phase III data from the REGARD and RAINBOW trials.

ASCO and the CAP Release Updated Guideline on HER2 Testing in Breast Cancer

The American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) recently issued a joint, updated guideline aimed at improving the accuracy and reporting of human epidermal growth factor receptor 2 (HER2) testing in patients with invasive breast cancer. The guideline update is based on a systematic review of medical research literature, providing oncologists and pathologists with detailed recommendations for how to test for HER2 overexpression, interpret the results, and recommend HER2-targeted therapies. The guideline, originally issued in 2007, is being published in ASCO’s Journal of Clinical Oncology (JCO) and the CAP’s Archives of Pathology & Laboratory Medicine. The joint guideline was prepared by an ASCO/CAP Update Committee consisting of experts in breast cancer and cancer biomarkers.

Researchers to Identify Genetic Biomarkers for Aggressive Breast Cancer

The Avon Foundation for Women recently awarded a $300,000 grant to Dolores Di Vizio, MD, PhD, associate professor in the Department of Surgery and the Department of Pathology and Laboratory Medicine and a member of the Cancer Biology and Urologic Oncology Research Programs at the Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute to advance scientific research in aggressive breast cancer.

Di Vizio will collaborate with the Cedars-Sinai Women’s Cancer Program to investigate biomarkers in patient blood samples that may identify individuals with aggressive breast cancer. Biomarkers are genes or other molecules that can indicate a person’s predisposition to specific medical conditions.

Research findings have the potential to create a novel standard of care and a new source of biomarkers. The possible new source of biomarkers, known as large oncosomes, are tumor-derived vesicles that transmit signaling complexes between cell compartments, providing valuable insight into the progression of disease. Findings may also help researchers and clinicians predict the aggressiveness of breast cancer earlier in the diagnostic process.

“This kind of research is the essential foundation to get us to our real goal, which is to improve diagnostic and prognostic capabilities and find effective treatments for breast cancer,” said Di Vizio. “With this study, we hope to identify previously unrecognized large oncosomes as potential biomarkers in advanced tumors that can be visualized, quantified and isolated using methods easily translatable to the clinic.”

Funding from the Avon Foundation for Women, a nonprofit organization and longtime supporter of Cedars-Sinai, will provide an opportunity for researchers to further spearhead new technologies, therapies and surgical interventions that may provide better patient outcomes, beginning at diagnosis.

Working with Di Vizio to provide these advancements is collaborator Beth Y. Karlan, MD, director of the Women’s Cancer Program, director of the Division of Gynecologic Oncology in the Department of Obstetrics and Gynecology, the Cedars-Sinai Board of Governors Chair in Gynecologic Oncology and the director of the Cedars-Sinai Gilda Radner Hereditary Cancer Program.

“I’m excited to be a collaborator on this research study, as it holds promise to provide tangible improvements in earlier diagnostics and detection in aggressive breast cancer and is perfectly aligned with the program goals of the Cedars-Sinai Women’s Cancer Program,” said Karlan. “This Avon Foundation for Women grant will further our program’s commitment to studying cancer biology, developing new approaches to early detection and preventing and improving cancer survival for all patients.”

This is the first study on large oncosomes analyses in patients with breast cancer. Pilot funding for this grant is supported by the Martz Breast Cancer Discovery Fund.

Source: EurekAlert!

Researchers Develop Specific Tests to Identify Cancer Biomarkers in Dermatomyositis

Researchers from major universities in the U.S. have developed specific tests to identify cancer biomarkers in patients with dermatomyositis—a systemic inflammatory disease associated with increased risk of malignancy. According to study findings published in the American College of Rheumatology (ACR) journal, Arthritis & Rheumatism, the assays detect antibodies against anti-transcriptional intermediary factor-1 (TIF-1γ) and nuclear matrix protein NXP-2.

Patients with dermatomyositis experience muscle weakness, skin inflammation, and sometimes inflammation of the lung. Most patients with dermatomyositis have auto-antibodies circulating in their bodies that cause distinct clinical disease features. Medical evidence suggests that these auto-antibodies in dermatomyositis patients stem from specific immune responses that shape various characteristics (phenotypes). In addition, up to 20% of those with dermatomyositis are at increased risk of malignancies.

“For the physician treating patients with dermatomyositis, identifying those at higher risk for cancer is a top priority,” explains Dr. David Fiorentino from Stanford University in Redwood City, Cal. “Our team focused on creating specific tests to detect antibodies against two specific proteins and then testing if those antibodies can identify dermatomyositis patients at higher risk of cancer.”

The team used both immunoblotting and immunoprecipitation techniques to detect antibodies against TIF-1γ and NXP-2 proteins. Blood analysis was performed on 111 patients from Stanford University Dermatology Clinic and 102 patients from the Johns Hopkins University (JHU) Myositis Center. Both groups were similar in gender and age at diagnosis.

Results show that 17% and 38% of subjects in the two cohorts combined had antibodies against NXP-2 and TIF-1γ, respectively. Using the specific assays, researchers found 83% of dermatomyositis patients with cancer had a reaction to NXP-2 or TIF-1γ. Further analysis indicates that cancer, older age, and male gender were linked to NXP-2 or TIF-1γ antibodies, with anti-NXP-2 specifically associated with cancer in men.

“Our findings confirm the link between cancer and age in dermatomyositis, with a sharp increase in frequency at roughly 60 years of age.” concludes Dr. Fiorentino. “By determining the presence or absence of NXP-2 and TIF-1γ antibodies, we believe that this will aid clinicians in identifying those with the highest cancer risk.”

Study: Most patients with cancer-associated dermatomyositis have antibodies to nuclear matrix protein NXP-2 or transcription intermediary factor 1-gamma [Arthritis & Rheumatism]

Source: EurekAlert!