mosaiques and U.S. FDA sign contract for collaboration in discovery and validation of biomarkers for assessment of drug toxicity
25-02-2009: mosaiques diagnostics and therapeutics AG announced the signing of a collaborative agreement with the U.S. Food and Drug Administration. The aim of this collaborative project is the identification and validation of protein- and peptide biomarkers for drug toxicity in urine. Based on preliminary experiments, it is anticipated that toxic effects of drugs will result in indicative changes in the proteome of bodyfluids, before gross pathological changes become apparent.
The U.S. Food and Drug Administration will contribute know how on drugs, expected drug toxicities, as well as conduction animals studies. mosaiques diagnostics will contribute know how on proteome analysis (especially preparation of urine and capillary electrophoresis coupled mass spectrometry) and on data evaluation, calibration and multivariate statistics. It is anticipated that these biomarkers, once validated, will enable a more accurate assessment of potential drug toxicity, consequently identification of potentially serious side effects of therapeutics at an early stage of development and before actual pathological changes.
mosaiques’ founder and CSO, Prof. Dr. Dr. Harald Mischak adds: “Our progress over the last five years has been remarkable. Our method is unlike any other currently available. We are aiming to reduce or even prevent adverse effects of drugs by implementing our technology in (pre)clinical testing. This agreement with the FDA underlines the potential of the protein pattern technology for modern medicine and appropriate treatment.”
Drug-induced toxicity represents a significant problem in health care delivery: Over 100,000 people die per year from adverse effects of medications in the U.S. (Starfield, JAMA 2000, 284: 483-485). This has led to an intense awareness of drug-induced side effects, which may hamper the deve ... more
mosaiques diagnostics and therapeutics AG announced the signing of a collaborative agreement with the U.S. Food and Drug Administration. The aim of this collaborative project is the identification and validation of protein- and peptide biomarkers for drug toxicity in urine. Based on prelimi ... more
Coronary artery disease (CAD) is the leading cause of morbidity and mortality worldwide. A vast amount of deaths and disabilities caused by CAD could be cut by an early diagnosis, enabling effective individual actions for preventing clinical events like acute myocardial infarction.
Researc ... more
The mosaiques diagnostics & therapeutics AG was established in Hannover (Germany). The company's core competence is the early and reliable detection of diseases enabling personalized medicine during therapy and drug development. The company utilizes diagnostic polypeptide patterns (DiaPat® ... more
The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before th ... more
The US Food and Drug Administration has ordered 23andMe to “immediately discontinue marketing” its direct-to-consumer genetic tests unless and until the agency grants it regulatory approval. In a warning letter released on November 25, the FDA states that 23andMe’s saliva collection kit and ... more
Epigenomics AG announced that it has submitted the fourth and final module of its Premarket Approval (PMA) to the United States Food & Drug Administration (FDA) for its blood-based Epi proColon® test for the detection of colorectal cancer in December 2012 as previously indicated, thereby co ... more
FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation.
FDA is also responsible for advancing the public hea ... more