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Clinicians Tap Watson to Accelerate DNA Analysis and Inform Personalized Treatment Options for Patients

IBM Watson Health (NYSE: IBfM) recently announced that it is collaborating with more than a dozen leading cancer institutes to accelerate the ability of clinicians to identify and personalize treatment options for their patients. The institutes will apply Watson’s advanced cognitive capabilities to reduce from weeks to minutes the ability to translate DNA insights, understand a person’s genetic profile and gather relevant information from medical literature to personalize treatment options. The project is part of IBM’s broader Watson Health initiative to advance patient-centered care and improve health.

NICE Recommends Genomic Health’s Oncotype DX® Test To Guide Chemotherapy Treatment Decisions For Qualified Early-Stage Invasive Breast Cancer Patients

Genomic Health, Inc. recently announced that the National Institute for Health and Care Excellence (NICE) in the United Kingdom has issued its final guidance recommending Oncotype DX® as the only multi-gene breast cancer test for use in clinical practice to guide chemotherapy treatment decisions for patients with early-stage, hormone receptor-positive, invasive breast cancer. Consistent with leading international breast cancer treatment guidelines, including ASCO®, NCCN®, ESMO® and St. Gallen, NICE’s recommendation recognizes the unparalleled evidence of the clinical validity of the Oncotype DX test and its ability to enable physicians and their patients to make more informed, individualized decisions.

“It is encouraging to see growing recognition of the value of genomic testing. Its provision has enhanced the care of breast cancer patients around the world and it will now be available as an option in the UK,” said David Miles, M.D., medical oncologist at Mount Vernon Cancer Centre, Northwood, Middlesex, United Kingdom. “NICE’s recommendation for the use of Oncotype DX in the UK is an important step forward, enabling physicians and patients to make better-informed treatment decisions based on the biology of an individual patient’s breast cancer.”

To date, more than 1,500 women in the UK have utilized the Oncotype DX test to help guide their treatment decisions. Breast cancer is the most commonly diagnosed cancer in women, with almost 50,000 people diagnosed each year in the UK. Most of these patients are diagnosed with early-stage, invasive breast cancer and a significant number of them could benefit from this test under the NICE recommendation.

“The decision of whether or not to undergo chemotherapy is an extremely important and difficult one for patients, not only due to the many side effects associated with treatment, but also due to the hardship for the patient and her family and the loss of income due to days off work. Allowing patients and their physicians to make more personalized treatment decisions can help improve outcomes for the rising number of early-stage breast cancer patients in Europe,” said Kathi Apostolidis, vice president, European Cancer Patient Coalition, Brussels, Belgium, and a two-time breast cancer survivor, commenting on the NICE announcement. “We hope NICE’s decision will also inspire other European countries to provide broader access to novel diagnostics such as Oncotype DX, which allows informed decision making for sparing the burden of chemotherapy from those who do not need it.”

With data showing that only four out of 100 early-stage invasive breast cancer patients benefit from chemotherapy, the Oncotype DX test helps improve patient outcomes by personalizing treatment decisions through assessment of the risk of cancer recurrence and chemotherapy benefit.

“Given NICE’s rigorous review process and its influence throughout the region, we believe this decision brings us an important step closer to achieving our mission to improve the quality of treatment decisions for cancer patients across Europe and around the world,” said Steven Shak, M.D., executive vice president of research and development, Genomic Health. “Our extensive body of clinical evidence highlights the unique ability of our test to play a critical role in breast cancer treatment, while providing a positive impact on health systems worldwide. Based on NICE’s recommendation, we will work with NHS healthcare providers and commissioners to provide broad access to the Oncotype DX test for UK patients.”

The robust body of evidence supporting Oncotype DX includes 15 clinical studies in more than 6,000 patients; 18 decision impact studies from 10 countries, which consistently demonstrate an approximate 30 percent change in treatment recommendations; and more than 20 studies from nine countries, showing that the use of the test is cost-effective in all health systems analyzed.

Source: PR Newswire

Abbott Announces New Test to Help Doctors Determine Personalized Treatment Path for Patients with Hepatitis C

Abbott recently announced that it has introduced the first FDA-approved hepatitis C virus (HCV) genotyping test for patients in the United States. Abbott’s fully automated RealTime HCV Genotype II test determines the specific type or strain (referred to as the genotype) of the HCV virus present in the blood of an HCV-infected individual. Genotyping the HCV virus provides physicians with important information they can use to create a personalized, targeted diagnosis and treatment path to improve clinical outcomes.

“Hepatitis C is known as the silent killer as many of the symptoms go unnoticed. When patients are identified, determining their specific genotype is important to ensuring they receive the treatment that will prove to be most effective. The introduction of this test for broad use in the U.S. is a significant advancement in helping to address an important public health issue,” said HIV and viral hepatitis expert, Carol Brosgart, M.D., Clinical Professor of Medicine, Division of Global Health, University of California San Francisco.

According to the Centers for Disease Control and Prevention (CDC), more than 75 percent of adults with hepatitis C are baby boomers — born between 1945 and 1965 — and most of them don’t know they are infected. In 2012, the CDC recommended that all baby boomers talk to their doctor and get a one-time test for HCV since this group is five times more likely to have the virus. Once a patient is diagnosed with HCV, a doctor would order a hepatitis C genotype test. The Abbott RealTime HCV Genotype II test is run on the fully automated m2000 platform, which provides laboratories substantial improvements in workflow efficiency to meet the increased demand.

“The Abbott RealTime HCV Genotype II test adds yet another test to the Abbott portfolio for a full spectrum of hepatitis C testing—from ensuring blood supply safety and providing initial screening to enabling targeted diagnoses, identification of the right treatments, and the monitoring of response to therapies,” said John Coulter, vice president, Molecular Diagnostics, Abbott. “Abbott continues to expand diagnostic testing options in the infectious disease area to benefit the healthcare system and enable doctors to improve patient care.”

Source: Abbott

med fusion and Theranostics Health Release Novel Cancer Theranostic Test

med fusion and Theranostics Health will introduce the first of the TheraLink™Assays for use in patients with malignant diseases at the American Society of Clinical Oncology (ASCO) Annual ’13 Meeting, held in Chicago, IL from May 31, 2013 through June 4, 2013. The TheraLink™ HER Family Assay for primary, recurrent and metastatic breast cancers provides a molecular analysis of each patient’s unique cancer, based upon the functional activity of signal transduction pathways known to modulate cancerous growth. This ‘theranostic’ assay provides a comprehensive molecular profile of the HER family of cell surface receptors and three key signaling pathways modulated by the HER family which have important roles in the therapeutic approach to treating breast cancer. The TheraLink™ HER Family Assay is the first in a series of similar assays based upon measuring a panel of analytes, including a number of drug targets.

med fusion and Theranostics Health will also announce that they are entering into an exclusive distribution agreement for Theranostics Health’s TheraLink™ HER Family Assay. Under the terms of the agreement, med fusion and its affiliate, Pathologists Bio-Medical Laboratories (PBM), will provide a gateway for access to the theranostic test for the McKesson Network of oncologists, which includes US Oncology and Texas Oncology and to the oncologists of the Baylor Healthcare System. Oncologists will be able to order the assay through their pathology services directly from med fusion.

The TheraLink™ HER Family Assay measures the total amount and activation (phosphorylation) status of 14 critical proteins, receptors and signaling pathway members, providing actionable information for ten currently marketed therapeutics. Starting with a few histopathology sections taken from a core needle biopsy or open resection, the assay is a reverse-phase immunoassay that leverages the extreme sensitivity and precision of microarray technologies to measure these very low abundance proteins, with analyte-specific quantitation provided by on-array calibration samples along with positive and negative controls. The assay provides oncologists with actionable information on drug targets, directly linking active drug targets and the available therapies to identify the most effective personalized treatment options.

“We believe med fusion provides Theranostics Health with a unique opportunity to advance the use of the TheraLink™ Assays,” says Glenn Hoke , President and CEO of Theranostics Health. “Through relationships with their founders, including the McKesson family of health care companies and the Baylor Healthcare System, med fusion provides Theranostics Health with a strong marketing and distribution partner to ensure these assays find utility in the clinical setting.”

“Signal pathway analysis provides some of the most relevant information for targeting cancer therapies,” says Gary L. Smith , Ph.D., Interim CEO and Chief Operating Officer of med fusion. “Furthermore, our collaboration with Theranostics and PBM continues to support med fusion’s model of developing and creating strategic alliances that expand our offering of personalized diagnostic testing services within a patient-centric model of care delivery.”

Source: PR Newswire

Firm Hopes Big Data Can Personalize Health Care

When Colin Hill’s father was diagnosed with later-stage prostate cancer last summer, he was treated the same as every other patient with the illness.

This standardized approach bothered Hill, who believes medicine should approach each patient’s illness as unique, with medication tailored to the person’s history and biology.

“You show up to the hospital, and it’s like Groundhog Day,” Hill said, with patients being cared for the same way, over and over again. “It’s this outdated standard of care created for this hypothetical average patient. But no one’s an average patient.”

A genetic analysis of the tumor in his 69-year-old father, Foster Hill, found he had a genetic variant of the cancer that does not usually respond well to the hormone therapy Lupron, the current standard of care. But not knowing what else would work, doctors gave Foster Hill Lupron anyway. Luckily, the treatment seems to be helping, and his father’s outlook is much improved.

Hill hopes a Kendall Square company he founded 13 years ago, GNS Healthcare, will eventually improve medical care for his father — and for countless others — by providing personalized treatment. GNS is among the leaders in using Big Data analytics to learn more about diseases, patients, and treatments.

With data from thousands of cases, GNS uses artificial intelligence to determine what treatment made the crucial difference for each patient.

The company is deploying enormous computing power to produce a more complete understanding of treatments for rheumatoid arthritis, diabetes, cancers, and other illnesses.

For example, it is working with the Dana-Farber Cancer Institute and Mount Sinai Medical School to build a computer model of multiple myeloma, so researchers can better understand what works well for patients today, as well as develop more effective treatments for the blood cancer. It is involved in a similar collaboration with Brigham and Women’s Hospital and several other partners to learn more about multiple sclerosis.

Harvard Medical School recently agreed to use a GNS computing platform to analyze how cells replicate or transform into different types, for insights into­ conditions such as cancer and neurodegenerative diseases, Hill said.

And the company has a partnership with the Centers for Medicare & Medicaid Services and Health Services Advisory Group to assess health care quality measures, as well as other recent deals with pharmaceutical companies, hospitals, and advocacy groups, and the insurance giants Aetna and Blue Cross Blue Shield.

“It’s exciting times for us,” Hill said, after 13 years of developing his approach to analyzing health care. “We are now in the thick of things.”

Hill did not always have such an absorbing interest in science. He went to college at Virginia Tech — mainly to play tennis. “I was more serious than I was good,” he quipped.

But while there, he became fascinated by physics and chaos theory — the idea that complex patterns could result from simple rules.

His imagination was stoked by a summer job in 1996 at Santa Fe Institute, an interdisciplinary research center focused on highly complex issues. Hill then went on to graduate from McGill and then Cornell University.

By then, the Human Genome Project was becoming a reality, capturing the attention of many scientists, including a young Hill.

“That’s when two and two came together,” Hill said. “It was like ‘Oh yeah, the stuff we’re doing, though it’s pretty theoretical, it is going to be the thing that links these pieces together,’ ” including chaos theory, genetics, Big Data, and health care.

Now he’s in the middle of the so-called Big Data revolution in health care. Companies such as GNS have an enormous capacity for crunching troves of information on patients, diseases, and medical outcomes collected by medical providers, insurers, and other big players.

Hill likes to say he wants GNS to capture the “data exhaust thrown off” by every interaction a patient has with the health care system, from the doctor’s office to the hospital to the pharmacy. A bad reaction to medication is a data point worth having; ditto for other side effects, as well as results of all kinds of procedures and interventions — bad or good.

While such data sets are getting easier to find, Hill said, genetic information is still too expensive to be truly useful.

“What we don’t have yet for my dad and for other men with prostate cancer is a large coherent set of data on prostate cancer patients that includes the molecular level,” Hill said.

With information aggregated from thousands of cases, Hill said, GNS uses artificial intelligence algorithms developed out of chaos theory to determine what treatment made the crucial difference for each patient, and with it what is likely to work best for the next patient — rather than simply trying one medication after another, as is often done today.

“What we’re trying to get at is not just patterns and trends, but reverse engineer the mechanisms that gave rise to the data,” he said. “We’re trying to find the cause-effect relationships within the data.”

This ability to predict results is what sets GNS apart, said Dr. Atul Butte of Stanford University, one of the academic leaders of the Big Data movement. That’s the “nifty part of their technology,” Butte said.

Alexis Borisy, a partner at the Boston life sciences venture capital firm Third Rock Ventures, said GNS is in the vanguard of Big Data companies analyzing health care information.

“They’ve had a chance to learn, refine, and they’ve kept with it so they’ve had a lot of experience to build on,” Borisy said.

He and Hill have known each other since they were young business executives more than a decade ago, and he said he has tremendous respect for Hill’s intelligence, persistence, and communication skills.

“He is one of the visionaries in the space,” said Borisy, who also serves as chairman of Foundation Medicine, a molecular information company, and interim chief executive of Warp Drive Bio, both of Cambridge. “I think it’s fair to say he’s kept GNS growing and building by the force of his personality and the force of his efforts.”

Source: The Boston Globe