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Ancora Pharmaceuticals Awarded National Institute Of Health Grant For Continued Malaria Vaccine Research
With exciting pre-clinical results showing that its carbohydrate-based vaccine can combat cerebral malaria (CM), which causes inflammation of the brain, Ancora Pharmaceuticals has received another grant from the National Institute of Health (NIH) to research whether its vaccine candidate will also prevent severe malaria anemia (SMA).

MicroRNAs Help Control HIV Life Cycle
Scientists at Burnham Institute for Medical Research (Burnham) have discovered that specific microRNAs (non-coding RNAs that interfere with gene expression) reduce HIV replication and infectivity in human T-cells. In particular, miR29 plays a key role in controlling the HIV life cycle. The study suggests that HIV may have co-opted this cellular defense mechanism to help the virus hide from the immune system and antiviral drugs. The research was published today in the journal Molecular Cell.
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Swine Flu Might Infect 40% Of The US Population In The Next 24 Months
Health authorities in the United States have voiced concern that 40% of the country"s whole population could be infected with the swine flu (H1N1) virus over the next 24 months. The estimates are based on data gleaned from the 1957 flu pandemic which killed nearly 70,000 people in the country. That pandemic was not as severe as the 1918-1919 Spanish flu one. If one hundred and twenty million people caught swine flu this time round, and vaccine campaigns were not successful, the eventual death toll could be in the hundreds of thousands.
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AMP Urges Inclusion Of Molecular Diagnostic Tests In Comparative Effectiveness Research

The Association for Molecular Pathology (AMP) recently released the text of a comment letter it has provided to the Federal Coordinating Council for Comparative Effectiveness Research (CER) in which AMP sets forth its recommendations for priority areas on which to focus CER activities. "CER is garnering substantial attention in Congress and among other policy makers who see it as a method to examine the comparative effectiveness of treatments, including how they relate to coverage and reimbursement decisions" wrote AMP President Jan A. Nowak, MD, Ph.D. "Diagnostic tests will most definitely be included in this paradigm, especially when the effectiveness of treatments will vary among different population subgroups. Unfortunately, the value of diagnostics in improving clinical outcomes has not been appreciated adequately in the past; therefore, considering the role of genomics under CER will be critical." Dr. Nowak continued to say that in order for CER to be a success, it will be essential to train experts in diagnostics (including molecular diagnostics) in current health services research methods as well as to train health services researchers in the technical areas they will assess. This cross training will be essential to ensure that the research methods are technology appropriate. "There is much less experience in assessing the role of the diagnostic test itself in appropriate and cost effective management of individual patients," wrote Dr. Nowak. "Therefore, AMP encourages the Coordinating Council to invest in the cross-training of researchers and diagnostics experts as well as to build the infrastructure within the agencies to understand and review data from different types of technologies." The AMP letter recommends the devepment of a model process for CER regarding clinical laboratory tests. This model should include the creation of a panel of experts consisting of physicians and scientists, including laboratorians with molecular diagnostics expertise, economists, and reimbursement specialists; the creation of an electronic clearinghouse for information on CER projects similar to http://www.clinicaltrials.gov; the development and adoption of standards for the collection and storage of data from genetic testing laboratories in order to facilitate interoperability among databases; and a requirement that data from technologies and tests being assessed be generated from CLIA-, CAP-, ISO-, or FDA- certified institutions. Additionally, AMP wrote that in order to routinely incorporate information that relates patient outcomes to genetic variations into clinical care, there is a need to jointly fund large, carefully designed comparative effectiveness trials for molecular tests with observational comparative effectiveness studies that complement the randomized controlled trials by including patients who do not necessarily meet the inclusion criteria for traditional prospective trials. AMP"s comment letter also called for measures for the evaluation of genomic tests and clinical molecular diagnostics laboratories. For the public to reap the benefits of effective molecular tests, it is critical that all laboratories meet high performance standards and participate in proficiency testing programs utilizing appropriate reference and control materials. Specifically the letter recommends funding a program to develop new reference materials to aid the continued advancement of quality measures in laboratory medicine; the development of proficiency testing methods as alternatives to distributing surrogate test specimens; and, the development of appropriate quality assurance measures for new technologies such as whole genome sequencing. Finally, as Dr. Nowak wrote, "Despite the possibility of saving the healthcare system thousands of dollars per patient and improving the quality of care, diagnostics have been historically under valued. AMP hopes that any CER activities will include research to explore the value, beyond simply cost, of diagnostic tests to patients, providers, payers and the larger health care system." Full text of the AMP comment letter can be found here. Mary Steele Williams Association for Molecular Pathology


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