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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

bioTheranostics To Present Data on CancerTYPE ID and Breast Cancer Index at 2013 ASCO Annual Meeting

bioTheranostics, Inc., a leading provider of molecular diagnostic solutions for cancer, recently announced that 11 data presentations will be released during the American Society of Clinical Oncology (ASCO) annual meeting May 31–June 4, 2013, in Chicago. The studies highlight the clinical utility of the company’s CancerTYPE ID® assay and Breast Cancer IndexSM (BCI), with results supporting the role of these molecular tests in individualized treatment programs for cancer patients.

bioTheranostics also will host an Industry Expert Theater educational presentation titled, “Demanding Certainty in Metastatic Cancer Diagnosis: The Clinical Impact of
CancerTYPE ID®,” June 2, 2013, at 11:30 a.m. The company’s products will be demonstrated at booth #23041.

“These studies are part of a large and growing body of clinical evidence demonstrating the positive impact our CancerTYPE ID and Breast Cancer Index molecular tests have on the management of cancer patients,” said Richard Ding, president and CEO of bioTheranostics. “The data provide key insights into the value of our molecular tests in influencing clinical decision making and impacting patient outcomes and healthcare costs, and we look forward to sharing and discussing the results during the 2013 ASCO meeting.”

The studies were conducted by researchers at leading institutions, including Linköping University (Sweden); Louisiana State University Health Sciences Center; Massachusetts General Hospital; Sarah Cannon Research Institute; University of California, San Francisco, School of Medicine; University of Kentucky; University of Pittsburgh Medical Center; and the University of Texas MD Anderson Cancer Center.

CancerTYPE ID Posters & Abstracts

  • Poster presentation: Molecular tumor profiling (MTP) of poorly differentiated neoplasms (PDN) of unknown primary site. Greco FA, et al. Abstract #11080.
  • Multivariate analysis of prognostic factors in cancer of unknown primary (CUP) patients treated with site-specific therapy based on the 92-gene cancer classifier. Schnabel CA,
    et al. Abstract #e15006.
  • Impact of the 92-gene assay on cost of diagnosis of tumor type in metastatic cancer of uncertain origin. Bentley TG, et al. Abstract #e15104.
  • Effect of the 92-gene molecular classifier on therapeutic decision-making in cancers of uncertain primary. Schroeder B, et al. Abstract #e15130.
  • Use of the 92-gene assay to identify tumor type and direct predictive biomarker testing in limited tissue specimens. Operana TN, et al. Abstract #e19072.
  • Poster presentation: Diagnostic utility and prognostic performance of a 92-gene cancer classifier to molecularly profile periampullary adenocarcinomas (PAA). Overman MJ, et al. Abstract #4133.
  • Renal cell carcinoma (RCC) presenting as cancer of unknown primary (CUP): Diagnosis by molecular tumor profiling (MTP). Hainsworth JD, et al. Abstract #e15501.
  • Poster presentation: Gene expression profiling (GEP) to predict the primary site of metastatic neuroendocrine tumors (NETs) presenting with an unknown primary. Woltering E, et al. Abstract #4141.
  • Confirmation of non-small cell lung cancer (NSCLC) diagnosis using ALK testing and genetic profiling in patients presenting with carcinoma of unknown primary site (CUP). Penley WC, et al. Abstract #e19062.

Breast Cancer Index Poster & Abstract

  • Poster presentation: Prediction of early and late distant recurrence in early-stage breast cancer with Breast Cancer Index. Zhang Y, et al. Abstract #594.
  • Health economic analysis of Breast Cancer Index in patients with ER+, LN- breast cancer. Gustavsen G, et al. Abstract #e11504.

Abstracts for the 11 studies concerning bioTheranostics’ molecular tests can be accessed on the ASCO website.

Source: bioTheranostics

Roche and Isis Pharmaceuticals Form Alliance for Huntington’s Disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Isis Pharmaceuticals, Inc (NASDAQ: ISIS) recently announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis’ ASOs and Roche’s proprietary “brain shuttle” program with the objective of increasing the brain penetration of ASOs with systemic administration.

Huntington’s disease is an inherited genetic brain disorder that results in the progressive loss of both mental faculties and physical control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications. Presently, there is no effective treatment or cure for the disease, and current treatments focus on reducing the severity of some disease symptoms.

Initially, research will focus on Isis’ lead drug candidate that blocks production of all forms of the huntingtin (HTT) protein, the protein responsible for HD and thus has the potential to treat all HD patients. Isis is also conducting research into treatments that specifically block production of the disease-causing forms of the HTT protein which has the potential to treat subsets of HD patients. In parallel, Roche will combine its proprietary brain shuttle technology with Isis ASO technology that, if successful, will also allow systemic administration of antisense drugs to treat asymptomatic patients.

Under the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche’s “brain shuttle” program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration.

Commenting on the deal, Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche, said: “Huntington’s is a severely debilitating neurodegenerative disease and a large unmet medical need. Patients experience gradually worsening motor function and psychological disturbances, with a significant shortening of life expectancy after the disease is diagnosed. Treatments are urgently needed, and we believe that the Isis approach in combination with Roche’s brain shuttle represent one of the most advanced programs targeting the cause of HD with the aim of slowing down or halting the progression of this disease.”

Shafique Virani, Global Head Neuroscience, Cardiovascular & Metabolism at Roche Partnering, added: “Central to the partnership is Roche’s brain shuttle program, which we see as highly complementary to Isis’ drug development work. This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

“We are pleased to be working with Roche, a global leader in drug development with significant experience in developing and commercializing drugs to treat neurological diseases. We believe that Roche’s expertise in developing CNS drugs, along with their clinical development experience, will greatly enhance our development efforts for this program and allow us to move forward more rapidly. In addition, by utilizing Roche’s brain shuttle technology with our antisense drug discovery capabilities, we have the potential to significantly improve the therapeutic potential for this program,” said B. Lynne Parshall, Chief Operating Officer of Isis. “By partnering our more complex and nuanced research and development programs earlier in development, like our Huntington’s disease CNS program, we add value and resources with partners that bring unique benefits.”

“We are excited to be working with Roche,” said Frank Bennett, Senior Vice President of Research at Isis. “We believe our mature antisense drug discovery platform is a perfect fit for Roche’s neuroscience franchise, and we anticipate a fruitful collaboration to advance our pre-clinical compounds.”

CHDI Foundation, a non-profit foundation exclusively dedicated to the development of therapies that slow the progression of HD, provided financial and scientific support to Isis’ HD drug discovery program through a development collaboration with Isis. CHDI’s support has enabled Isis to make significant progress in discovering a drug to treat HD. Together Isis and CHDI demonstrated that antisense compounds can be used to inhibit the production of HTT protein in both brain and peripheral tissues, and that the inhibition of normal HTT protein was well tolerated. Over time, CHDI will be reimbursed for its support of Isis’ program out of the milestone payments received by Isis. CHDI will receive $1.5 million associated with the signing of the Roche agreement. CHDI will continue to provide advice to Isis and Roche on the development of antisense drugs to treat patients with HD.

Isis also recognizes the tremendous benefit provided to its HD program by its academic collaborators, Drs. Don Cleveland at the Ludwig Institute, University of California San Diego and David Corey at University of Texas Southwestern. These collaborators have been instrumental in Isis’ early preclinical work demonstrating that antisense drugs can inhibit the HTT protein and produce activity in animal models of disease.

Source: Isis Pharmaceuticals

Pilot Study Demonstrates Home BNP Testing Is Feasible & Suggests Home Monitoring May Have Value in Guiding Therapy for High-Risk Patients

Alere Inc. (NYSE: ALR), a leading provider of near-patient diagnostics and health information solutions, recently announced the final results of the HABIT pilot study, which were recently published in the Journal of the American College of Cardiology. Led by Dr. Alan Maisel , Professor of Medicine at the University of California, San Diego, the study is the first to capture serial data from patients at high risk for recurrent acute clinical heart failure decompensation (ADHF), who performed a fingerstick BNP self-test from home for a period of 60 days. Results not only demonstrate that home BNP testing is safe and feasible for heart failure patients, but also indicate that BNP patterns following treatment for ADHF provide a wealth of information that may facilitate more personalized treatment leading to significant outcomes benefits.

In the United States, nearly one out of every four patients hospitalized for ADHF is rehospitalized within 30 days of discharge from the hospital, and the bulk of the costs associated with managing these patients derives from rehospitalization. Consensus among clinical experts is that more than 50% of hospital readmissions can be prevented through increased attention to modifiable factors that affect pulmonary congestion. But, while shortness of breath, edema, and weight gain can often signal pulmonary congestion, these symptoms may not appear in up to one-third of all heart failure patients. Changes in natriuretic peptide (NP) levels, along with monitoring for symptoms, signs, and weight changes, have been shown to improve the certainty of predicting heart failure decompensation. Up until now, however, NP measurements have been excluded from home heart failure monitoring programs because of the need for phlebotomy.

The HABIT study, a multi-center, single-arm, double-blinded observational prospective clinical trial, was designed to monitor daily concentrations of B-type natriuretic peptide (BNP) and determine the extent to which they correlate with ADHF and related adverse outcomes. A total of 163 patients with ADHF who were discharged from the hospital or being treated in an outpatient setting measured their weight and BNP levels daily for a period of 60 days using a fingerstick test run on the Alere™ Heart Check. Adverse outcomes for ADHF were measured as a composite of events that included cardiovascular death, admission for decompensated heart failure, or clinical heart failure decompensation requiring either parenteral therapy or adjustments to oral medications.

A total of 6,934 daily BNP values were recorded, with a median of 46 measures per patient over the course of the monitoring period. 40 patients had 56 events. Correlations between BNP measures weakened over time, and the dispersion between measures grew. When the monitoring period for each subject was broken into intervals based on ADHF events, there were 39 (18.4%) intervals of upward-trending BNP corresponding to a risk increase of 59.8% and 64 (30.2%) downward-trending intervals corresponding to a risk decline of 39.0%. There were also 94 (44.3%) intervals with one or more days of weight gain corresponding to an increased risk of 26.1%. Investigators concluded that daily weight monitoring is complementary to BNP measurement, but changes in BNP levels ultimately signaled larger shifts in risk, both upward and downward.

“Our results demonstrate that it is feasible and safe for heart failure patients to measure their results at home on a daily basis,” said Alan Maisel . “The incremental data from serial home measurements following an episode of ADHF appear to provide a novel means with which to identify those patients who are at highest risk of recurrent decompensation. The pattern or trend in BNP values may be used to identify when to correlate with a face-to-face clinical assessment or therapeutic intervention, or to guide therapy with specific medication changes without additional office visits.”

Investigators have determined that the results of the HABIT pilot study warrant an interventional trial to measure the extent to which home BNP testing impacts formal outcomes measures that include hospital readmissions. A study comparing today’s standard of care, which involves monitoring symptoms of heart failure and body weight changes following hospital discharge under the management of hospital-based outpatient heart failure clinics, to an algorithm that incorporates routine, home BNP measurements is set to commence before the end of 2013.

Study: Primary Results of the HABIT Trial (Heart Failure Assessment With BNP in the Home)

Source: PR Newswire

Deadly Effects of Certain Kinds of Household Air Pollution Lead to Call for Biomarker Studies

Almost four million people die each year from household air pollution (HAP) caused by exposure to the combustion of biomass fuels (wood, charcoal, crop residues, and dung), kerosene, or coal. These individuals are among the tens of millions who rely on such products to cook their meals, heat their rooms, and light their homes. Those in lower and middle income countries are among the hardest hit by the effects of HAP exposure, which also causes childhood respiratory infection, chronic lung disease, and cardiovascular disease. Exposure to biomass fuel is associated with low birth weight, asthma, and tuberculosis.

Given these effects, the large populations at risk, and a growing global interest in lower-cost energy sources, researchers from three continents have published a comprehensive overview of the current approaches to HAP assessments, the aims of biomarker development, and the state of development of tests which have the potential for rapid transition from the lab bench to field use. Their findings are addressed in the article, “Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease,” which is published online by the American Journal of Physiology-Lung Cellular and Molecular Physiology.

The effort is being led by William J. Martin II, MD, Associate Director for Disease Prevention and Health Promotion, Eunice Kennedy Shriver National Institute of Child Health and Human Development, the National Institutes of Health (NIH). The team is also comprised of Jamie Rylance, BM BS BMedSci MRCPTM&H, and Stephen Gordon, MA MD FRCP DTM&H, Professor and Chair in Respiratory Medicine, both from the Liverpool School of Tropical Medicine, Liverpool, United Kingdom; Luke P. Naeher, PhD and Olorunfemi Adetona, PhD, both from the University of Georgia, College of Public Health, Department of Environmental Health Sciences, Athens, Ga.; Archana Patel, IMD, DNB, MSCEs, Professor and Head of the Department of Pediatrics, Indira Gandhi Government Medical College, Nagpur, India; John R. Balmes, MD, Professor of Medicine, Division of Occupational and Environmental Medicine, University of California, San Francisco School of Medicine, San Francisco, Ca.; and Derek K. Rogalsky, Georgetown University School of Medicine, Washington, D.C.

Current approaches to HAP assessment, challenges

The researchers found that current HAP assessment tools include direct quantitative measurement of products of incomplete combustion, as well as qualitative methods (including use of questionnaires or the categorization of HAP exposure by type). However, direct exposure assessments via personal monitoring are problematic due to the size, portability and recording capacity of equipment, and acceptability to the user.

Despite the new devices currently being field tested and scaled up for commercial use to address these concerns, specific particulate measurement alone cannot differentiate between the multiple sources of pollution such as mixtures of HAP, tobacco smoke, and outdoor pollution. “The grand challenge to the research community is to produce simple and validated tests that better identify populations that are at risk from HAP, and individual responses to exposure reduction strategies,” according to Dr. Martin.

The researchers also found that current HAP exposure measurement methods are expensive, technically challenging, difficult to use with large population studies, and have substantial limitations, making an urgent case for the development of biomarkers of both exposure and health effects. These findings have led to their call for studies into biomarkers of exposure and predictors of respiratory disease.

Martin and his colleagues note that further development of biomarkers of susceptibility and effect could facilitate large scale studies examining the impact of HAP on health and disease in human populations. In the end, new biomarkers would: (a) improve epidemiological accuracy in association studies with health effect; (b) reduce the cost and complexity of monitoring intervention studies; (c) provide data for educating the public and policymakers about risk; and (d) inform clinicians and the public health community about human environmental exposures that are not well characterized.

Conclusion

China uses more coal than any other nation to meet the energy needs of its one billion citizens. In India, 55 percent of electrical power was generated by coal last year, and as austerity measures in Europe grow stronger, coal is becoming an attractive alternative to natural gas. But the more affordable option could also prove to be the more harmful, and potentially add to the illness and death tolls already linked to HAP exposure.

Martin and his colleagues have put together a comprehensive overview of the dangers posed by biomass fuels and the research gaps in assessing HAP threats. The article is a “must read” for anyone interested in public health.

 Study: Household air pollution: a call for studies into biomarkers of exposure and predictors of respiratory disease

Source: EurekAlert!