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QIAGEN Adds Promising Genomic Biomarkers for Assessing Prognosis in Treatment of Blood Cancers to Personalized Healthcare Pipeline

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced it has acquired an exclusive global license to the biomarker SF3B1 from the University of Tokyo. SF3B1 is believed to play a critical role in the prognosis of patients with myelodysplastic syndromes (MDS), a group of hematological cancers in which bone marrow does not produce enough healthy blood cells. Mutations of this gene, which is an important component of the spliceosome machinery, indicate a more favorable disease progression for patients than the “wild-type” gene, so testing for these gene variants could potentially provide important guidance for treatment based on a personalized healthcare approach to MDS.

Scientists Identify Biomarker to Predict Immune Response Risk After Stem Cell Transplants

Researchers from Indiana University, the University of Michigan, the Fred Hutchinson Cancer Research Center and the Dana-Farber Cancer Institute have identified and validated a biomarker accessible in blood tests that could be used to predict which stem cell transplant patients are at highest risk for a potentially fatal immune response called graft-versus-host disease.

Although transplant specialists have been able to reduce its impact, graft-versus-host disease remains a leading cause of death among patients who receive a stem cell transplant from another person, known as an allogeneic transplant. Such transplants are used to treat blood and bone marrow cancers such as leukemia and multiple myeloma, often as a last resort. Graft-versus-host disease occurs when immune cells from the transplant see the patient’s body as foreign and attack it.

Approximately 20,000 allogeneic stem cell transplants were performed worldwide in 2012. Thirty to 40 percent of stem cell transplant recipients whose donor is related will experience graft-versus-host disease. The percentage could rise to 60 to 80 percent if the patient and donor are not related.

The researchers found that patients with a high level of a protein named ST2 were more than twice as likely to have graft-versus-host disease that resisted standard treatment with steroids; and nearly four times as likely to die within six months of the transplant. Their findings were reported in the Aug. 8 edition of the New England Journal of Medicine.

“What we found particularly significant was that this marker was a better predictor than the clinical severity of the disease when it was diagnosed,” said Sophie Paczesny, M.D., Ph.D., associate professor of medicine at the IU School of Medicine and senior author of the study.

Thus, patients with low ST2 levels were more likely to respond to treatment regardless of how serious their graft-versus-host disease was graded, while patients with high ST2 levels were less likely to respond to treatment, whether their disease was graded less serious or more serious.

“This blood test, which is currently available to clinicians, will make informed treatment possible as the clinicians will now be able to adjust therapy to the degree of risk rather than treating every patient the same way,” Dr. Paczesny said.

In addition, while the disease most commonly appears about 30 days after the transplant, higher ST2 levels in blood samples taken as early as 14 days after transplant — far before the clinical signs of graft-versus-host disease are apparent — were associated with an increased risk of death from the toxicity of the transplant.

Therefore, the authors noted, early identification of patients who likely won’t respond to standard treatments is important and would allow physicians to consider additional therapies and early intervention. On the other hand, patients with low risk will not need to have additional medicine further suppressing their immune system. But, they cautioned, additional large prospective studies are needed to better define the levels of risk predicted by the ST2 marker.

Study: ST2 as a marker for risk of therapy-resistant graft-versus-host disease and death. [New England Journal of Medicine]

Source: Indiana University School of Medicine

Regional Cancer Care Associates (RCCA) and GenPath Oncology Announce Diagnostic Laboratory Partnership to Benefit Nearly a Quarter Million NJ Cancer Patients

Regional Cancer Care Associates LLC (RCCA), one of the nation’s largest oncology physician groups, announced today it has partnered with GenPath Oncology (www.genpath.com), a business unit of BioReference Laboratories to bring advanced diagnostics to the practice’s more than 230,000 cancer patients.

RCCA and GenPath have joined together to create an advanced molecular laboratory on the grounds of the John Theurer Cancer Center in Hackensack, NJ. This initiative expands the group’s offered services into key diagnostic testing for their patient community. The first step in this multi-year partnership is the development of a physician-owned immunophenotyping service for hematological malignancies. In addition, GenPath will also be providing a significant amount of esoteric diagnostic testing to RCCA’s network of 92 oncology physicians in 27 locations.

The partnership with GenPath will strengthen RCCA’s mission to raise the standard of cancer care across the state, while remaining competitive in a changing healthcare environment where medical practices increasingly face declining reimbursements and rising administrative costs.
“We recognize that providers are forming larger practices to meet the challenges of a changing market. BioReference continues to adapt as our clients evolve. RCCA and BioReference both share a commitment to patient care and support scientific innovation for this purpose,” said Marc D. Grodman, M.D., President and CEO of BioReference Laboratories.

“RCCA was established to offer the highest quality and most comprehensive cancer care and our partnership with BioReference expands upon that goal. Through this relationship, RCCA is well positioned to offer the most innovative cancer diagnostics,” said Edward J. Licitra, M.D., Ph.D. and Board Chairman of RCCA.

RCCA is one of the nation’s largest oncology physician networks. As a group, RCCA is transforming healthcare, by providing a broad range of quality cancer services to patients while also controlling the cost of patient care through practice-management consistency, more competitive contractual rates and hospital privileges, resulting in long-term savings for payers. The new RCCA testing service, scheduled to begin in June, will focus on providing timely and clinically-relevant results for patient care in a cost effective manner.
According to Licitra, oncology is at a crossroads—increasing longevity in the population has the unintended effect of raising the incidence of cancer. “Oncology care is advancing, becoming more specialized and therefore getting more expensive. Over time, some cancer care may become unaffordable, and that would be tragic. We need to take steps now that allow us to modulate the growth of the cost of cancer care while maintaining quality,” he explained.

GenPath, headquartered in Elmwood Park, was selected from among the largest cancer laboratories in the nation, due to its scientific expertise and longstanding relationships with many of RCCA’s physicians. GenPath offers oncology providers a single source for cancer patient management, including bone marrow morphology, solid tumor diagnosis, molecular genetics for personalized medicine, and even routine clinical testing specific for cancer patients. In addition, GenPath offers two innovative proprietary testing modalities, OnkoMatch, a tumor genotyping test that covers more than 100 possible mutations in 14 clinically targetable oncogenes, and GenArray which scans a patient’s entire genome for chromosomal abnormalities, offering superior coverage over conventional methods such as FISH and cytogenetics.

Source: PR Newswire

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

Singapore Scientists Identify New Biomarker For Cancer In Bone Marrow

Singapore scientists have identified FAIM, a molecule that typically prevents cell death, as a potential biomarker to identify an incurable form of cancer in the bone marrow. Patients with this form of cancer usually do not get cured with current standard treatments such as chemotherapy and stem cell transplantation, with an average survival of only about four years. FAIM could thus be a therapeutic target in these patients, as drugs developed to target the molecule could destroy multiple myeloma cells and hence eradicate the cancer.