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New Study Shows Circulating Tumor Cell Enumeration – as Part of Composite Biomarker Panel – May Serve as a Surrogate for Efficacy Response in Metastatic Castration-Resistant Prostate Cancer

Janssen Diagnostics, LLC recently announced results from a study presented at the European Cancer Congress in Amsterdam, Netherlands, that demonstrated circulating tumor cell (CTC) enumeration using CELLSEARCH®, along with lactate dehydrogenase (LDH) as part of a composite biomarker panel, was an efficacy-response surrogate for survival in managing patients with metastatic castration-resistant prostate cancer (mCRPC). The results show mCRPC patients with greater than or equal to five CTCs and an abnormal LDH level at 12 weeks of treatment have a poorer prognosis than those with lower CTC counts and normal LDH values, with a one- and two-year survival probability of 25 percent and 2 percent compared to 82 percent and 46 percent, respectively. Findings suggest therapeutic alternatives should be considered for patients in the high-risk category at 12 weeks.

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.

Nodality, Inc. Reports Promising Rheumatoid Arthritis Study Results to Predict Patient Treatment Response to TNF Inhibitors

Nodality, Inc., an innovative biotechnology company advancing discovery, development and use of transformative therapies by revealing functional systems biology, recently announced results of the Company’s comprehensive research study to identify cell markers (biomarkers) of disease activity and treatment success in rheumatoid arthritis (RA) patients. The study findings demonstrated that Nodality’s SCNP technology, which measures functional pathways at the single cell level, can be used to identify biomarkers of responsiveness to treatment with tumor necrosis factor inhibitors (TNFIs). RA affects an estimated two million Americans, and TNFIs constitute the most commonly prescribed therapy. Approximately half of patients respond to treatments such as TNFIs, leaving a substantial unmet need to identify which patients are more likely to respond to current therapies. Optimizing use of currently available therapies could potentially delay tissue damage and progression of disease.

SCNP provides the core technology foundation for Nodality’s programs dedicated to improving clinical medicine by increasing the efficiency of therapeutic R&D programs, enhancing life cycle management for commercialized drugs, and introducing new predictive diagnostics. The study results were featured in an oral presentation titled, Comparison of functional immune signaling profiles in peripheral blood mononuclear cells (PBMC) from rheumatoid arthritis (RA) patients versus healthy donors (HD) using Single Cell Network Profiling (SCNP) (Abstract W7.02.04), at the 15th International Congress of Immunology (ICI) in Milan, Italy, taking place August 22 to 27, 2013. The findings were presented by S. Louis Bridges, Jr., M.D., Ph.D., Marguerite Jones Harbert-Gene V. Ball, MD Professor of Medicine, Director, Division of Clinical Immunology and Rheumatology, University of Alabama School of Medicine.

“Nodality’s research program demonstrates the great promise and potential in gaining a better understanding of disease biology and applying this to the development of prognostic and predictive biomarkers for autoimmune diseases such as RA,” commented Alessandra Cesano, M.D., Ph.D., Chief Medical Officer of Nodality. “I look forward to the final results of this program, one of the most comprehensive of its kind. Our technology, based on immune-biology, can predict which RA patients will respond to specific therapies and reveal the mechanisms of drug resistance, thus informing alternative therapeutic strategies.”

The Nodality research program compares healthy and diseased peripheral blood cells at the single cell level, studying samples obtained through the national Treatment Efficacy and Toxicity in Rheumatoid Arthritis Database and Repository (TETRAD). Nodality anticipates completing its research program and announcing the key findings later this year.

Laura Brege, Nodality’s President and Chief Executive Officer, stated, “ICI has provided an important opportunity to showcase one of our key programs in immunology, further validating our broadly enabling SCNP platform. This platform has led to major collaborations in immunology addressing significant unmet needs among patients, as well as new predictive diagnostic modalities in blood cancers. Ultimately, Nodality’s goal is to accelerate and make more efficient the development of new therapeutic agents for serious diseases affecting large patient populations within immunology and oncology, two areas of continuing significant unmet clinical need.”

Additional program results were featured in a second oral presentation at the ICI Congress in a presentation titled, Functional proteomic interrogation of immune cell crosstalk and the effects of cytokine-targeted inhibitors using Single Cell Network Profiling (SCNP) (Abstract W7.02.03).

Source: Nodality, Inc

Quest Diagnostics Introduces Comprehensive Opioid Therapy Genetic Test Based on CYP450 Biomarker License with Transgenomic

Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services, recently announced the availability of a new lab-developed genetic test to aid the delivery of personalized opioid pain-relieving treatment. It is believed to be the first clinical lab to offer testing for variants in all cytochrome P450 (CYP450) genes known to influence the CYP450 enzyme system, which affects metabolism of opioids and other medications.

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