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Luminex Corporation Receives FDA and European Clearance for a New Personalized Medicine Genotyping Assay, xTAG CYP2C19 Kit

Luminex Corporation (NASDAQ: LMNX) recently announced it has received U.S. FDA and European clearance for a comprehensive genotyping assay, xTAG® CYP2C19 Kit. This new test enables a personalized approach to aid physicians in determining patient treatment plans based on certain genetic variants of the P450 2C19 gene.

Almac Offering TruSight Tumor Profiling Next-Generation Sequencing Service

Almac recently announced they are now offering a Tumor Profiling service running Illumina’s next-generation sequencing (NGS) TruSight Tumor™ panel as part of their biomarker discovery, development and delivery solutions.

Almac, a personalised medicine company with CAP accredited and CLIA certified laboratories, extends their portfolio of services by offering TruSight Tumor™ to complement its current range of RNA, DNA and protein based technologies for biomarker analysis.

Almac is currently running many bespoke diagnostic assays for pharma customers for early phase clinical trial enrichment. The TruSight Tumor™ panel enables additional profiling of these patient samples to provide Almac’s pharma partners with further important information on emerging biomarkers that may also impact drug response.
The TruSight Tumor™ panel was developed by Illumina for their MiSeq® system, allowing targeted DNA sequencing and reporting on the mutation status of 26 genes which are most commonly mutated in solid tumors including lung, colon, ovarian, melanoma and gastric cancers.

One of Almac’s key strengths is many years of experience in working with formalin fixed paraffin embedded (FFPE) tissue. The TruSight Tumor™ panel is specifically designed for use with FFPE samples, and enables the highest levels of sensitivity for mutation detection with limited DNA input requirements.

“Almac is committed to the development of personalised medicine through the delivery of a wide range of innovative solutions. We are pleased to announce the expansion of our NGS service to include TruSight Tumor™” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic business unit.

Source: Almac

Broad Institute and Bayer Join Forces to Develop Novel Treatment Options in Cancer Therapy

The Broad Institute has entered into a strategic alliance with Bayer Healthcare in the area of oncogenomics and drug discovery. The goal of this collaboration is to jointly discover and develop therapeutic agents that selectively target cancer genome alterations over a period of five years.

“We look forward to working together with our Bayer colleagues to translate scientific discoveries into novel cancer therapeutics,” said Professor Eric Lander, President and Director of Broad Institute. “The Broad’s deep expertise and knowledge in cancer genomics, chemical biology and drug discovery perfectly complement Bayer’s decades of experience in pharmaceutical development. We are thrilled to be working with Bayer in such a visionary collaboration.”

Oncogenomics is a promising field of oncology research that identifies and characterizes genes which are associated with cancer. Cancer is caused by the accumulation of DNA mutations which lead to uncontrolled cell proliferation and tumor formation. The goal of oncogenomics research is to identify new genes which, when mutated, stimulate or lose the ability to suppress tumor cell growth. These genes may provide new insights into cancer diagnosis, prediction of clinical outcomes, and new targets for cancer therapies. Targeting individual patient tumor mutations will allow for the development of more personalized cancer treatments.

“We are excited to collaborate with such a prestigious research institute as the Broad Institute which brings together researchers from Harvard, MIT, and the Harvard hospitals,” said Professor Andreas Busch, Head of Global Drug Discovery and Member of the Executive Committee of Bayer HealthCare. “The Broad Institute’s scientists have created impressive systematic catalogues of mutational changes across different types of tumors, laying a foundation for the development of new cancer therapies and diagnostics. The alliance is another significant step underlining our engagement in the field of oncology and personalized medicine.”

As part of the collaboration, the Broad Institute will share its oncogenomic expertise. Both parties will explore their compound libraries and use their screening platforms as well as medicinal chemistry expertise to benefit joint projects. The collaboration will be based on joint decision-making and the rights to the research findings are shared equally between the partners. Joint research and joint steering committees will be established for the initiation and selection of projects, and as governance structures. Bayer will have an option for an exclusive license for therapeutic agents at preclinical development stage. Financial terms of the agreement were not disclosed.

Source: Broad Institute

Quintiles Asks, ‘Why Not Test for Many Biomarkers at Once?’ When Evaluating Therapies for Cancer Patients

Calling the concept “pre-profiling,” Quintiles (Research Triangle Park, NC) is collaborating with US Oncology Research (the research arm of McKesson Specialty Health) to test the value of running multiple biomarker tests at once for cancer patients—in this case those with metastatic colorectal cancer (mCRC). Either for initial therapy, or as a step to selecting candidates for clinical trials, the current practice is to look for genomic data that is relevant to one type of therapy; if the suitable genomic variant is found, the clinician then knows that the patient is a good trial candidate, or that the patient could benefit from a specific therapy. Quintiles is suggesting to look at many variants or makers initially and then make treatment or trial recruitment decisions.

In practice, says Dr. Jeffrey Spaeder, CMO at Quintiles, a biopsy would be retrieved from the patient, DNA and other genomic information sequenced, abnormalities identified, and bioinformatics analysis conducted, then returning the results back to the clinician. “All these steps sound intuitively straightforward, but they involve complex handoffs of information and clinical decisions,” he says. Understanding what the clinician can do with the data needs to be determined; what choices the patient might have for one therapy or another; and in the final analysis, whether better outcomes could be achieved remain to be evaluated. Eventually, the multiple-biomarker process could become a step in the clinical pathways that various organizations have developed for treatment of cancers. “Early indications from this study suggest that we can provide physicians and patients with early visibility on potentially clinically actionable biomarkers within a rapid two-week timeframe. This level and speed of analysis has promise to save valuable time in administering potentially life-saving therapies to patients, and reduce the development times of precision medicines.”

The biomarker field, while demonstrating exciting new potential and spurring the evolution of personalized (or “precision”) medicine, is fraught with operational difficulties. Insurers are selective about what biomarker tests they are willing to pay for; practitioners have varying enthusiasm for the tests, and the clarity around which tests lead to beneficial outcomes are not clear. Even so, this study could be one of a series of medical innovations to make biomarkers a standard element of cancer therapy.

Source: Pharmaceutical Commerce

Exosome Diagnostics Enters Collaboration Agreement with Lilly for Exosome Blood-Based Biomarker Discovery

Exosome Diagnostics recently announced it has entered into a collaboration agreement with Eli Lilly and Company (NYSE: LLY) for biomarker discovery and validation using Exosome Diagnostics proprietary EXO50 nucleic acid extraction kit. Under the agreement, Lilly will gain early access to Exosome Diagnostics technology to help identify key gene mutations and expression levels in blood that may be correlated with drug response and disease recurrence. Financial terms were not disclosed.

“Exosome Diagnostics technology may provide a unique opportunity to gain insight into the biology of complex conditions such as cancer and immune disorders,” said Andrew Schade, senior medical director, diagnostic and experimental pathology at Lilly. “Exosome technology enables biofluid molecular sampling and the ability to monitor disease progression in real time. As Lilly explores new ways to pursue patient tailoring, we’ll continue to work with partners to expand our capabilities.”

“Accessing high quality messenger and microRNA directly from frozen patient fluid samples offers a rapid, cost-effective route to identify and validate biomarkers, which may be correlated with drug response and disease recurrence,” said James McCullough, chief executive officer of Exosome Diagnostics. “Lilly has accumulated an extensive and well annotated clinical blood sample biobank that provides a unique opportunity to track target biomarkers through the clinical trial process and help overcome the limitations of stored biopsy tissue.”

Exosomes and other microvesicles are secreted by all cells into all biofluids, and provide a natural biological packaging and distribution mechanism for RNA and DNA. Exosome Diagnostics’ rapid exosome isolation and extraction technology produces high-quality RNA and DNA, including full length mRNA and microRNA, from small volumes of patient biofluids, such as blood (serum and plasma), urine and cerebrospinal fluid, for analysis by standard PCR, array and sequencing instruments. Analysis can be performed on fresh or frozen fluid samples, allowing for broad, flexible and convenient analyses of clinical trial samples, both in real-time and retrospectively, with no special preservation methods required. Exosomes and their protected nucleic acid contents are being investigated in a broad range of diseases including cancer, CNS disorders such as Alzheimer’s and Parkinson’s disease, cardiovascular disease, maternal/fetal medicine, and chronic kidney disease, among others. In July, QIAGEN and Exosome Diagnostics signed an agreement for the creation of High-Performance Biofluid Sample Preparation Kits for Personalized Healthcare Research which covers the exclusive supply of these products upon availability in 2014.

Source: Exosome Diagnostics