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Caris Life Sciences Adds Next-Generation Sequencing to Enhance Evidence-Based Tumor Profiling Service for Cancer Patients

Caris Life Sciences®, a leading biosciences company focused on fulfilling the promise of personalized medicine, recently announced the commercial availability of mutational analysis by Next-Generation Sequencing (NGS), which will replace its former mutational analysis platform. NGS joins an extensive collection of tumor profiling technologies currently employed by Caris Molecular Intelligence(TM) Service (MI Profile(TM)), including Immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH), restriction fragment length polymorphism (RFLP) and polymerase chain reaction (PCR), providing oncologists the most comprehensive molecular profiling capabilities commercially available today.

MI Profile(TM) offers comprehensive tumor biomarker analyses coupled with an extensive clinical literature evidence review, which matches potential therapies to patient-specific biomarker information. Oncologists are provided simple-to-read reports indicating which available chemotherapeutic, biologic and hormone therapies are potentially effective, along with those that are potentially less effective, based on the molecular profiling results. The report further provides information on appropriate and enrolling clinical trials for the patient. This service presents clinically-relevant, patient-specific information doctors can use to individualize cancer treatment.

Unlike other tumor profiling services on the market, which are often powered by a single technology platform, or hinge on the successful exploitation of a particular DNA mutation, Caris remains both technology- and biomarker-agnostic, employing a wide range of technologies to uncover a broad array of key biomarkers. With this unique approach, the company currently reports potentially clinically-relevant biomarker to drug associations in approximately 95 percent of patient cases, averaging more than 25 possible clinically-actionable biomarkers per patient.

“Evaluating DNA only doesn’t address the true complexity of the biology driving the cancer. It is essential to consider the significant impact of RNA and downstream alterations of the proteins involved in each patient’s disease,” said David D. Halbert, Chairman and Chief Executive Officer of Caris Life Sciences. “It’s imperative to perform a holistic and comprehensive analysis on a tumor, especially the proteins, which are the active agents. Anything less does a disservice to the treating physician and could potentially put a patient at risk.”

“Integrating next-generation sequencing further demonstrates our commitment to continually evolve with emerging science to provide our physicians with an unmatched comprehensive tumor profiling service,” said Tom Spalding, Senior Vice President & Group Head, Oncology, Caris Life Sciences. “As a result of this comprehensive approach, we believe we can provide significantly greater clinical utility than services that solely rely on single technology platforms. For example, NGS analysis alone would not provide oncologists with key insights into some of the most commonly used companion diagnostics, as FDA-approved labeling requires the use of specific and varied profiling technologies.”

NGS will power the mutational analyses performed in the company’s Select and Comprehensive profiles, enabling rapid examination and broader detection of somatic mutations across hundreds of hotspots in the cancer genome. Additionally, this critical technology enables the inclusion of emerging biomarkers that may have potential clinical or research applications. The addition of these emerging biomarkers will further enhance the utility of the Caris Registry┬«, which houses critical data on biomarker, drug and patient outcomes that may yield greater insights into the treatment of various cancers.

“From both breadth of information and research utility perspectives, NGS is most valuable when combined with other technologies like IHC and FISH to more comprehensively assess a patient’s tumor,”said Sandeep Reddy, M.D., Clinical Professor of Medicine at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA) and Senior Medical Director at Caris Life Sciences. “Sequencing alone may provide relevant results in smaller percentages of cancer patients, giving the treating physician only part of the full molecular picture. In contrast, Caris provides more meaningful biomarker analysis and delivershighly thorough interrogation of important biomarkers in the cancer pathway. Additionally, Caris’ approach also allows for compliance with FDA labeling on approved companion diagnostics.”

With more than 45,000 patients profiled to date, Caris Life Sciences houses the most comprehensive collection of biomarker profiles in the industry today. Beyond obvious research implications, this extensive database provides clinicians with critical information about the prevalence of biomarkers in unexpected disease states, allowing them to select personalized, tailored therapy regimens for their patients.

Source: Caris Life Sciences

Apceth and Indivumed to Develop Biomarker Platform for Targeted Cellular Therapies

apceth GmbH & Co. KG, located in Munich, Germany, and Indivumed GmbH, based in Hamburg, Germany, have entered into a partnership for the development of a predominantly tissue-based biomarker strategy for the treatment of solid cancers with cellular and/or gene therapeutics. The goal is to predict the response of a targeted cellular/gene therapy in different cancer types and to stratify patients to provide a more individualized cancer treatment with apceth’s innovative cell and cell-based gene therapeutics. A reliable biomarker platform will enable oncologists to identify those patients who will most likely benefit from the treatment with apceth’s therapeutics, thus establishing a unique and truly personalized therapeutic approach adapted to the needs of each cancer patient.

WaferGen Announces Two Gene Expression Profiling Panels for SmartChip Real-Time PCR System for High Throughput, Cost-Effective Biomarker Discovery and Validation

WaferGen Biosystems, Inc., a leading developer of state-of-the-art genetic analysis systems, today announced the availability of two gene expression profiling panels for the SmartChip Real-Time PCR System that will enable microRNA and cancer pathway profiling capability.

Quintiles Announces Suite of PI3K Biomarker Assays to Advance Oncology Therapies Targeting this Cancer Pathway

Quintiles today announced a comprehensive suite of biomarker assays to help bio pharmaceutical companies investigate the phosphoinositide 3-kinases (PI3K) cancer survival pathway, the focus of numerous anti-cancer therapies under development. Understanding the PI3K pathway is essential in developing new medicines to inhibit or block this pathway, thereby cutting off a metabolic function needed for certain cancers to survive.