Discover the Science of Health
Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid.
In recent years, people are turning more and more to the Internet for health information and to “self-diagnose.” With an increasing variety of medical apps available for the iPhone, iPad, Android, and other mobile platforms, self-diagnosis has become even more accessible. Unfortunately, however, checking the boxes next to a variety of symptoms and waiting for a mobile device to spew forth a litany of potential ailments lacks the sensitivity and accuracy of a human diagnostician. Further, those who are not trained in medicine may misinterpret symptoms as erroneously relevant or erroneously irrelevant, leading to misdiagnosis.
Biomarker Bulletin is an occasionally recurring update of news focused on biomarkers aggregated at BiomarkerCommons.org. Biomarkers are physical, functional or biochemical indicators of normal physiological or disease processes. The individualization of disease management — personalized medicine — is dependent on developing biomarkers that promote specific clinical domains, including early detection, risk, diagnosis, prognosis and predicted response to therapy.
Selventa, a biomarker discovery company that enables personalized healthcare through the stratification of patients based on disease-driving mechanisms, recently announced a US patent that relates methods and techniques that facilitate discovery of biomarkers, thus aiding in the development of predictive and prognostic diagnostic tests for therapeutics targeting complex multi-factorial diseases.
Increasing emphasis is being placed on biomarker discovery as the key to advancing personalized medicine.
Critical Diagnostics is a U.S.-based biomarker company focused on optimizing patient care in cardiovascular diseases, such as heart failure.
The success of personalized cancer therapeutics relies on the development of companion diagnostic assays that can identify the most appropriate cancer patient, tumor type and disease state. To address this need, SciClips, a Wisconsin-based open innovation platform company that enables scientists and researchers to collaborate and share research and ideas, recently launched a cancer (oncology) biomarker database.
The Bill & Melinda Gates Foundation is currently seeking letters of inquiry for the grant program Biomarkers of Gastrointestinal (Gut) Function and Health.
In a continuing effort to educate the public on the dangers of cigarette smoking, the FDA intended to require cigarette manufacturers to post large, graphic images on packages of cigarettes. This effort has been temporarily halted by an injunction passed down from U.S. District Court Judge Richard Leon last month. The FDA’s law blog explains that Judge Leon felt the warnings were not “purely factual and noncontroversial disclosures” and that “the Government’s actual purpose is not to inform, but rather to advocate a change in consumer behavior.”
EZ Vein is designed to ease the sometimes tricky job of inserting an intravenous catheter. The noninvasive device includes an inflation cuff that goes over the arm to redirect blood from deep tissue to the target vein near the skin’s surface to make more visible and accessible to a needle.
The medical device was invented by Dr. Robert Perry, a resident at Oklahoma University Medical Center. EZ Vein is so practical that federal regulators approved it in just 17 days.
According to Perry:
It was kind of a surprise. I wasn’t anticipating getting anything back until January, and I got it in October.
Source: NewsOK
(HT: Medgadget)
