An Institute of Medicine (IOM) study on “omics” tests at Duke University has found that such tests are susceptible to errors. The initial investigation began in 2009, when biostatisticians at MD Anderson Cancer Center voiced concern over the published claims of two Duke scientists that molecular patterns in tumor cells could indicate patients’ reactions to […]

At Pittcon, IBO sees many new products, which are defined as products released within six months of the show. From these products, each year IBO selects three that it feels are the most noteworthy for their innovation, technical achievements and commercial potential. This year, IBO has chosen instruments that meet these requirements in three different […]

A new Supreme Court ruling has re-examined the criteria for patenting diagnostic tests, which may have a significant impact on personalized medicine. The Court declared two tests patented by Nestlé’s Prometheus Laboratories invalid because the methods contained within them are already recognized and practiced by scientists. The Court dismissed Prometheus’s claim that its steps were […]

According to a new working paper from UnitedHealth Group, genetic tests are available for 2,500 conditions. There are between 1,000 and 1,300 genetic tests, but only 400 have evidence-based guidelines. Seven manufacturers lead the market and 1,000 US labs offer such tests. UnitedHealth estimates that in 2010 it spent $500 million on genetic and molecular […]

In his 2013 budget, President Obama proposed total federal R&D spending of $140.8 billion; a 1.4% increase over 2012 enacted levels. Basic and applied research funding would grow 1.5% and 5.0% to $30.6 billion and $33.4 billion, respectively. Development funding would decrease less than 1% to $74.1 billion. The proposal includes a 10.9% R&D boost […]

The FDA approved 34 new molecular entities in its fiscal year ending September 30, 2011; the highest number since 2007. Eleven biologics license applications were approved. Biologic approvals included a high number of orphan indicators and first-time approvals for companies. Seattle Genetics’ Adcetris for treating Hodgkin’s lymphoma and systemic anaplastic large cell lymphoma was approved. […]

The US Department of Agriculture’s Global Agricultural Information Network published a translation in early February of China’s “12th Five-Year Plan on National Food Safety Standards.” The Plan was released by the Ministry of Health on January 30 and comments were accepted until February 28. According to the document, China currently has 1,900 national food standards, […]

On February 9, the FDA released its guidelines on biosimilars, which propose an “abbreviated pathway” for approval that would vary by product. The biosimilar must be shown to be “highly similar” to the original. The requirements for clinical and animal studies would depend on an evaluation of analytical data, as well as scientific and manufacturing […]