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Archives for July 2013

Amplion Research Launches Version 2.0 of BiomarkerBase™, the Database of Clinical Biomarkers, Significantly Expanding Its Ability to Inform Investments in Molecular Biomarkers and Personalized Medicine

BiomarkerBase™ 2.0 now includes every validated biomarker in clinical use, along with a significantly improved user interface and expanded functionality. The team at Amplion Research, publishers of BiomarkerBase™, manually reviewed every IVD test cleared or approved by the FDA since 2000, adding to the extensive set of test, drug, and clinical trial data already included in the database.

“Being aware of all existing clinical applications for molecular biomarkers is an important part of the groundwork for biomarker development projects,” said Adam Carroll, Ph.D., Science Director at Amplion Research. “Our primary goal has always been to give our clients confidence that they have in front of them the complete set of validated clinical biomarkers. To achieve that goal, there is no substitute for manual curation of the data,” said Carroll. “Additionally, all of the linkages between biomarkers and the specific tests, drugs, and trials that define them were each individually reviewed, making BiomarkerBase™ a very robust reference tool.”

Data Enhancements

Along with every validated clinical biomarker, the database also includes every emerging clinical biomarker disclosed in a phase 3 or 4 clinical trial, and will soon include all phase 1 and 2 trials as well. BiomarkerBase™ also now includes publications in its dataset for the first time, and most biomarkers in the database include the total number of published clinical studies for each biomarker, with full publication details for the 10 most recent. Additional enhancements to published clinical data and data from other sources are already in progress.

Interface Enhancements

Biomarkers can now be browsed by target, disease, drug, company, or therapeutic area, and every IVD test, drug label, and clinical trial that includes the biomarker is listed, with direct links to the primary records at FDA and NIH. BiomarkerBase™ has a clean and intuitive interface that makes browsing biomarkers and their related information fast. The database is, at the same time, very well connected, both internally and externally, making it easy to follow the key links between different information types.

Stakeholders in biomarker projects at drug companies, diagnostics companies, contract research organizations, technology transfer offices, and investment firms are all using BiomarkerBase™ to stay on top of every clinical application for a molecular biomarker; every drug label that includes a biomarker; and every clinical trial that includes a disclosed biomarker.

Source: Business Wire

8 Questions about Biomarker Commons

Biomarker Commons launched just over three years ago with the goal of aggregating the latest biomarker and personalized medicine news.

Now, we really need your feedback. We’ve got 8 simple questions that should take you less than 5 minutes to complete. Please let us know how we’ve been doing and what we can do to improve our service.

Metabolon Announces Findings From Two Major Diabetes Outcomes Studies For its Quantose Prediabetes Test

Metabolon, Inc. a pioneering leader of advanced metabolomics, announced outcome results recently from two large-cohort studies evaluating the clinical utility of Quantose, the company’s blood test for prediabetes. The studies provided further evidence that the Quantose test identifies individuals at risk for type 2 diabetes earlier and more accurately than traditional risk factors alone.

The performance of Quantose was measured among 3,841 participants from the Relationship between Insulin Sensitivity and Cardiovascular Disease (RISC) and Botnia Prospective Study cohorts. Notably, among initially healthy participants in the RISC study with 3-year follow-up data:

  • Quantose biomarkers α-hydroxybutyrate (α-HB) and linoleoyl-glycerophosphocholine (L-GPC) independently and significantly predicted worsening glycemic control, and;
  • Quantose outperformed traditional risk measures such as fasting insulin, fasting glucose, BMI, and HOMA-IR in predicting insulin resistance and progression to impaired glucose tolerance.

In the Botnia Prospective Study with 9.5 year follow-up data:

  • Quantose biomarkers were found to predict incident type 2 diabetes independent of familial diabetes, sex, age, BMI, and fasting glucose.

These findings were published in two recent articles:

“Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance”, Diabetes; Ferrannini, Gall, et.al.; 2013; 62(5): 1730.

“A Novel Fasting Blood Test for Insulin Resistance and Prediabetes” Journal of Diabetes Science and Technology; Ferrannini, Cobb, et.al.; 2013; 7(1): 100.

The Quantose test reflects insulin resistance and detects progression to prediabetes and diabetes earlier than traditional glycemic measures such a hemoglobin A1C. The test is particularly useful in identifying prediabetic patients at greatest risk of disease progression and for whom drug, or other interventional therapy, may be appropriate. Diagnostic assessment with the Quantose test is well-aligned with the American Diabetes Association guidelines which recommend that physicians consider pharmaceutical intervention in high-risk prediabetics.

Beyond its immediate impact on the treatment of prediabetes, Quantose offers convincing evidence of the maturation of the field of metabolomics — and of the potential influence the discovery of novel metabolomic biomarkers will have on personalized medicine. Metabolon is committed to utilizing its systematic metabolomics discovery approach to develop diagnostics in the areas of metabolic, cancer and cardiovascular disease and provide biomarker research services by employing their high-throughput, advanced metabolomics platform.

“These studies are clear affirmation of Quantose value to predict early those individuals at risk for eventual onset of Type 2 diabetes which may provide clinicians the opportunity for treatment interventions that may reverse the prediabetic state.”, Eric Button, Senior Vice President of Diagnostics, Metabolon commented. Eric and other biomarker discovery experts from Metabolon will be present on July 22-24th at the 73rd Scientific Sessions of the American Diabetes Association. Visit booth #776 for more information regarding these studies or schedule an appointment with an expert to learn more about the Quantose test.

Study: Early Metabolic Markers of the Development of Dysglycemia and Type 2 Diabetes and Their Physiological Significance

Study: A Novel Fasting Blood Test for Insulin Resistance and Prediabetes

Source: Metabolon

Response Genetics, Inc. Announces Contract With Blue Cross and Blue Shield of Illinois

Response Genetics, Inc. (Nasdaq:RGDX), a company focused on the development and sale of molecular diagnostic tests that help determine a patient’s response to cancer therapy, recently announced that it has recently executed a provider contract with Blue Cross and Blue Shield of Illinois. Blue Cross and Blue Shield of Illinois has 7.4 million members, most of whom are located in the State of Illinois.

With the execution of this agreement, oncologists and pathologists affiliated with this health plan now have the ability to more easily offer Response Genetics’ suite of molecular predictive testing for their patients battling lung, colon, gastric, and melanoma cancers. Response Genetics’ tests provide treating physicians with actionable information that help enable the best therapy to be employed for each individual patient. The personalized medicine inherent in Response Genetics’ testing services brings with it a value proposition that is expected to improve patient outcomes and as a result enhance efficiencies in health care delivery.

The contract with this Blue Cross Blue Shield Association affiliate complements Response Genetics’ existing managed care network and gives the CLIA-licensed lab access to millions of additional Blue Cross Blue Shield-insured members located primarily in Illinois and the Midwestern United States. Blue Cross and Blue Shield of Illinois is the oldest and largest health plan based in Illinois.

Source: Response Genetics

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