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Pathway Genomics to Launch Next-Generation Sequencing (NGS) Comprehensive Cancer Panel Including BRCA1 and BRCA2

Pathway Genomics, a genetic testing laboratory on the forefront of bringing physicians a broad genetic testing portfolio covering a wide range of diseases, announces the pending launch of its inherited cancer panel with BRCA1 and BRCA2.

Pathway Genomics’ Hereditary Cancer DNA Insight test utilizes next-generation sequencing (NGS) technology and will analyze genes related to a selection of hereditary cancers including breast, ovarian, colorectal and others. The company notes that it intends to introduce all their cancer panels in August 2013.

“I am delighted to see laboratories like Pathway offering genetic tests for inherited cancers,” said Linda Wasserman, M.D., Ph.D., former Director of the Clinical Cancer Genetics Care Unit at Moores UCSD Cancer Center. “Next-generation sequencing is a critical step in making actionable genetic information more accessible to the physician, ultimately benefitting the patient.”

Inherited BRCA gene mutations are responsible for approximately five percent of breast cancers and about 10-15% of ovarian cancers. Patients who have deleterious BRCA mutations may also have increased risk of other cancers.

Jim Plante, President and CEO of Pathway said, “Pathway is committed to innovation in health care and to improving the health of millions of patients with increased risk of developing cancer. We believe Pathway Genomics’ Hereditary Cancer DNA Insight is an important test in our genetic portfolio and it will enable the medical community to progress towards more personalized health care at an affordable price.”

Pathway Genomics’ genetic tests screen patient DNA using advanced technologies to provide scientifically-validated and actionable information for a wide range of genetic and inherited diseases including recessive diseases, traits that impact heart health, drug response and nutrition.

Source: Pathway Genomics

Cancer Genetics Signs Agreement with MultiPlan

Cancer Genetics, Inc. (OTCQB: CGIX) (“CGI” or the “Company”), a leader in oncology-focused personalized medicine, has entered into an agreement with MultiPlan, Inc. (“MultiPlan”), the industry’s most comprehensive provider of healthcare cost management solutions.

As a participating provider in the PHCS and MultiPlan networks, CGI will be able to offer providers with its cutting-edge proprietary tests and testing services in hematological and urogenital cancers. MultiPlan contracts with 900,000 healthcare providers across the United States, and has an estimated 57 million consumers accessing MultiPlan network products.

Dr. Anthony Sposato, MultiPlan Vice President & Corporate Medical Director, stated, “The inclusion of CGI’s oncology-focused testing services and proprietary tests are a welcome addition to our provider networks, allowing for efficient incorporation of genomic information in patient care.”

“This is a tremendous opportunity for us and further validates our position in cancer diagnostics,” stated Panna Sharma, president and CEO of CGI. “We expect the MultiPlan agreement to increase access to our oncology-focused services for patients and clinicians while providing the potential to streamline reimbursements.”

Source: Cancer Genetics

Mayo Clinic Forms Joint Venture with Cancer Genetics

Mayo Clinic and Cancer Genetics Inc. (OTCQB: CGIX) recently launched OncoSpire Genomics, a joint venture with the singular goal of improving cancer care by discovering and commercializing diagnostic tests that leverage next-generation sequencing.

“Individualized medicine and genomic testing give us a fundamental understanding of the inner workings of wellness and disease. We recognize the transformative power of these tools and are committed to using every resource at our disposal to bring individualized medicine to our patients,” says Gianrico Farrugia, M.D., a Mayo Clinic gastroenterologist and director of Mayo Clinic’s Center for Individualized Medicine. “That is why this joint venture is so important.”

OncoSpire will focus on mutually identified projects in the Biomarker Discovery Program within Mayo’s Center for Individualized Medicine. Initial focus areas will include hematological and urogenital cancers, and potentially other cancers, as selected by a scientific review committee. OncoSpire will be based in Rochester and will be equally owned by Cancer Genetics and Mayo Clinic. Cancer Genetics will contribute operating capital, commercial expertise and other guidance. Mayo will contribute in-kind with sequencing and laboratory resources, clinical and research expertise, and other operational resources. Financial details of the agreement were not disclosed.

“We expect this new venture to accelerate cancer biomarker discovery research already underway at Mayo Clinic Cancer Center,” says Robert Diasio, M.D., cancer researcher and director of the Mayo Clinic Cancer Center. “Transforming discoveries into individualized cancer therapies will benefit patients, so we are excited to be part of these efforts.”

Research will be conducted in genetics and life sciences labs at Mayo Clinic, including Mayo’s Center for Individualized Medicine Biomarker Discovery Program and the medical genome facility, a resource that allows medical researchers to investigate how individual differences in the structure and function of human genomes influence health outcomes.

Technological advances, such as next-generation sequencing, have driven down the cost to perform whole genome sequencing. What originally took $3 billion over 13 years for the Human Genome Project and the first human genome sequence now can be accomplished for a few thousand dollars in a matter of days.

Panna Sharma, CEO of Cancer Genetics, says: “The combination of resources we are bringing together positions OncoSpire Genomics to create a major impact in the development of advanced genomic-based cancer diagnostics. Our investment in OncoSpire Genomics represents the potential for the paradigm shift in patient management that can result in more efficient use of health care resources, ultimately improving the cost structure of cancer diagnosis and treatment. We expect this will add value to our commercial offerings as next-generation sequencing becomes more widely accepted by the clinical community. A major factor behind our decision to work with Mayo was the depth of their world-class clinicians and thought leaders, who we believe are in a position to drive clinical value and clinical adoption for the tests being created by OncoSpire Genomics.”

Mayo Medical Laboratories and Mayo Clinic’s Department of Laboratory Medicine and Pathology will work with Mayo’s Center for Individualized Medicine to help bring discoveries from the joint venture to patients at Mayo Clinic and elsewhere. According to Frost & Sullivan, a health care industry analyst, the U.S. cancer biomarker testing market is expected to reach $11.5 billion by 2017.

“Next-generation sequencing will change the future of health care, especially in complex disease categories such as cancer,” says R.S.K. Chaganti, Ph.D., founder and chairman of Cancer Genetics. “We are pleased to have forged this new relationship with Mayo with the goal of furthering next-generation sequencing technologies. Cancer Genetics’ strength in hematological and urogenital cancers brings a tremendous knowledge base to the partnership. Together we can make a significant impact in the pursuit of personalized medicine that is transforming cancer treatment.”

OncoSpire has formed a scientific review committee, which is composed of six researchers, thought leaders and clinicians.

Source: Mayo Clinic

Penn Medicine’s New Center for Personalized Diagnostics Unlocks Cancer’s Secrets

Just like a massive iceberg jutting out of the ocean, many of cancer’s genetic underpinnings remain hidden under the surface, impossible to predict or map from above. The foreboding shadows and shapes that appear on CT scans and MRIs – and even in the field that doctors see when they zoom in to look at cancer cells under a high-powered microscope – are just the tip of the iceberg.

Penn Medicine’s new Center for Personalized Diagnostics, a joint initiative of the department of Pathology and Laboratory Medicine in the Perelman School of Medicine and the Abramson Cancer Center, is diving deeper into each patient’s tumor with next generation DNA sequencing. These specialized tests can refine patient diagnoses with greater precision than standard imaging tests and blood work, all with an aim to broaden treatment options and improve their efficacy.

“We’re using the most advanced diagnostic methods to unlock cancer’s secrets,” says David B. Roth, MD, PhD, chairman of the department of Pathology and Laboratory Medicine. “A tumor’s genomic profile is the most critical piece of information for an oncologist to have when they’re deciding what therapy to recommend. The results of tests in the Center for Personalized Diagnostics reveal a genetic blueprint of each patient’s tumor that is as discrete and singular as a fingerprint.”

The Center for Personalized Diagnostics unites top experts in genomic analysis, bioinformatics, and cancer genetics – who use the most sensitive data analysis tools available to identify the rarest of mutations – with oncologists who treat patients and design clinical trials to test new therapies. Together, their efforts will provide cancer patients with cutting-edge diagnostic and therapeutic options.

The first group of patients who are undergoing testing through the CPD includes those with blood cancers and solid tumors of the brain, melanoma, and lung. Throughout 2013, the tests will be expanded for a wider range of cancer patients. Results are available within two weeks – twice as fast as most commercially available testing panels. All new and relapsed Abramson Cancer Center patients will receive this testing – conducted via simple blood tests and/or biopsy of tumor tissue or bone marrow – as part of their evaluation and diagnostic process. Interpretation of results is communicated one-on-one to patients and their caregivers by physicians and genetic counselors.

In contrast to the CPD’s offerings, individual genetic tests – which now proliferate in the marketplace, even for healthy people who may be interested in going on a spelunking expedition through their DNA – are time consuming and expensive to conduct, and they often yield information which is not clinically actionable. When these tests are offered for cancer patients, patients are often left with only a veritable alphabet soup detailing genetic information, with few plans for how to use those findings to conquer their cancer.

Since the CPD began operating in early 2013, however, tests in 80 percent of patients revealed genetic mutations that may be used to alter their treatment course or clarify their prognosis. The results are playing a role in:

  • Matching patients with existing therapies designed to target mutations previously associated only with different cancers. For instance, some lung cancer patients exhibit mutations of the BRAF gene, which is targeted by drug Vemurafenib, initially developed and approved for melanoma. Testing in the Center for Personalized Diagnostics is helping clinicians make new connections that will expand the indications for existing drugs.
  • Helping physicians determine which treatments a patient will respond to, or how well they will tolerate a particular treatment. Patients with the blood cancer acute myelogenous leukemia who express a mutation known as DNMT3A, for instance, are known to respond to higher doses of the drug daunorubicin. Learning this type of information prior to beginning treatment can help oncologists select and dose drugs in a way that will reduce side effects and boost patients’ quality of life during treatment – and increase their chance of completing their prescribed regimen.
  • Identifying patients who are likely to have a poor prognosis if treated with first-line therapies, which allows clinicians to set up a cascade of alternative therapies or, in the case of some blood cancer patients, expedite the search for a matching bone marrow donor.
  • Detecting resistance mutations that could slow or halt patients’ response to targeted drugs, which allows for custom-designed combination therapies to attack tumors through multiple pathways.

The Center’s research agenda operates in parallel with its clinical care mission. Each patient’s test results will add to an enormous repository of genomic mutation profiles that, combined with the ability to follow patients over time, will help clinical researchers identify new markers and mutation profiles to better predict the course of an individual patient’s treatment response and suggest new targets for therapy. As new mutations are detected and novel treatment options are identified, the gene testing panels will be modified and expanded, creating an evolving, real-time mutation profiling option.

“We see 11,500 newly diagnosed patients each year in the Abramson Cancer, and hundreds of others who seek our help when their cancers have not responded, or have returned, after receiving standard therapies elsewhere,” said Chi Van Dang, MD, PhD, director of the Abramson Cancer Center. “A key part of our mission is to provide each of these patients these tests as soon as possible, so that we can quickly tailor a treatment regimen that provides them the greatest chance of a cure.”

Source: Penn Medicine

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