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Cardiac Biomarker ST2 Proves Far Superior To Galectin-3 In A Head-to-Head Study

Critical Diagnostics recently announced that the study, “Head-to-head comparison of two myocardial fibrosis biomarkers for long-term heart failure risk stratification: ST2 vs. Galectin-3”, recently published online in JACC (the Journal of the American College of Cardiology) comparing the company’s novel cardiac biomarker ST2 to Galectin-3 (Gal-3), a biomarker from BG Medicine (NASDAQ: BGMD), found ST2 to be superior.

Evidence-Guided Molecular Profiling Offers New Hope for Oncologists Managing Difficult-to-Treat Cancers

Caris Life Sciences recently announced data from two studies presented at the 2013 European Cancer Congress (ECC 2013), which demonstrate the potential of evidence-guided molecular profiling to improve the treatment of patients with hard-to-treat cancers, including cancers of unknown primary (CUP) origins as well as rare tumors and cancers that have been refractory to treatment.

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.

Joint Assurex Health and Mayo Clinic Study Demonstrates Clinical Utility of Assurex Health’s Pharmacogenomic Test to Guide Treatment of Major Depressive Disorders

Assurex Health, a personalized medicine company focused on pharmacogenomics for neuropsychiatric disorders, recently announced the publication of a joint clinical study conducted by Assurex and Mayo Clinic which provides additional evidence for the effectiveness of the GeneSight pharmacogenomic test over the current method for selecting psychotropic medications. The study results were published on July 24, 2013 in Pharmacogenetics and Genomics. The primary outcome of the study showed a substantially greater baseline to endpoint decrease in depressive symptoms with higher rates of response and remission in the guided GeneSight group over empiric prescribing, which is the current standard of care. These results reinforce the benefit of GeneSight in providing more objective, evidence-based support for clinicians in selecting medications for patients with psychiatric disorders.

The prospective clinical trial, involving 227 participants divided into pharmacogenomic-guided treatment and treatment-as-usual groups, utilized the GeneSight interpretive report to categorize 26 antidepressants and antipsychotics into color-coded green, yellow, and red “bins” based on each participant’s genetic information and pharmacology of the medications. Significantly greater reductions in symptoms were observed for the GeneSight-guided group using multiple symptom rating scales completed by both clinicians and patients. Participants in the GeneSight-guided group experienced an overall greater than 2-fold improvement in both symptoms and likelihood to achieve remission.

Overall, results with GeneSight-guided treatment were superior to unguided treatment-as-usual. The study showed the ability of GeneSight to identify individuals who are likely to have a favorable outcome with specific pharmacotherapies, supporting the clinical utility of the GeneSight test. A four-fold greater improvement in depressive symptoms was observed in the GeneSight-guided group among participants who entered the study on medications most discordant (red-bin) with their pharmacogenomic profile.

Physicians for nearly 94% of patients in the GeneSight-guided group used the report to either switch participants off medications discordant with their genetics to medications in the green bin or to adjust medication dosages according to the participant’s GeneSight report.

These findings replicate and expand on the magnitude of the effect observed in a previous prospective joint clinical study from Assurex and Mayo Clinic published in Translational Psychiatry (Oct. 2012). This smaller study compared GeneSight-guided prescribing versus treatment-as-usual in adult patients with a primary diagnosis of a major depressive disorder over an 8 week period. Furthermore, a one-year blinded retrospective study of adult patients with a diagnosis of depressive or anxiety disorder published in Translational Psychiatry (Mar. 2013) demonstrated that patients taking discordant red bin medications based on the GeneSight report had substantially higher rates of medical utilization, 3-fold greater medical absence days, and 4-fold greater medical disability claims than patients on non-red bin medications.

“Multiple clinical studies have now demonstrated the clinical validity and clinical utility of our integrated, GeneSight combinatorial pharmacogenomic testing platform,” according to Bryan M. Dechairo, Ph.D., Senior Vice President, Medical Affairs & Clinical Development at Assurex Health. “Prescribing a medication regimen that is more likely to succeed because it is tailored to an individual patient’s genetic profile can help clinicians better manage each patient’s disorder and improve clinical outcomes.”

Source: PR Newswire

bioTheranostics is Now an In-Network Provider with Highmark Health Services for Its CancerTYPE ID Molecular Test for Metastatic Cancer

bioTheranostics, a leading provider of molecular diagnostic solutions for cancer, is now an in-network provider with Highmark Health Services, and the company’s CancerTYPE ID® molecular cancer classification test may be eligible for Highmark members based on the member’s individual benefits. Pittsburgh-based Highmark is one of the largest health insurers in the United States and the fourth-largest Blue Cross and Blue Shield-affiliated company, operating health plans that serve 5.3 million members.

CancerTYPE ID, an industry-leading molecular cancer classifier based on the expression of 92 genes, predicts tumor type in patients with metastatic cancers—among the most difficult to diagnose and treat cancers.

Richard Ding, president and CEO of bioTheranostics, said, “We are delighted that Highmark is recognizing the value of the CancerTYPE ID test, which is becoming a standard tool of metastatic cancer management. We have built a strong foundation of evidence supporting CancerTYPE ID—from clinical validity to clinical utility and health outcomes. We are working diligently with the payor community to make this high-value diagnostic test available to patients with metastatic cancer and the clinicians caring for them.”

Ding said that in managing metastatic cancer, achieving diagnostic certainty is critical to optimize site-directed therapies that reduce costs and avoid ineffective therapies for both payors and patients. More than 400,000 patients present with metastatic cancers in the United States each year. An accurate diagnosis is the first step toward personalized medicine, allowing clinicians managing these patients to treat them most effectively using site-specific therapy.

Source: BusinessWire