The US Institute of Medicine issued a broad set of guidelines for the development of 'omics-based tests. In its recommendations, the institute aims to establish best practices for taking an 'omics-based test into clinical trials and evaluating it for clinical utility and use, though not for taking a test from a clinical trial into clinical practice.
Agilent Technologies is collaborating with the US Food and Drug Administration on food-testing applications. Under the terms of the agreement, Agilent will develop new DNA-based tools for detecting and analyzing pathogens in food. The first part of the project is focused on developing an assay panel, using mass spectrometry-based geno-typing, to identify subtypes of Salmonella in food.
WaferGen Biosystems has appointed Ivan Trifunovich as its president, CEO, and director. Trifunovich is currently the executive chairman, president, and CEO of Helicos Biosciences, and will continue in that role part-time.
The US Food and Drug Administration published a guidance document to aid makers of medical devices
of low or moderate risk in preparing to submit their diagnostic and therapeutic products for pre-market -approval applications and de novo petitions.
The US Supreme Court invalidated two patents held by Prometheus Laboratories in a unanimous decision. The court ruled that the patents — which cover methods of determining proper dosing of thiopurine drugs for auto-immune diseases by correlating dosage levels of the drugs with metabolite levels in a patient's blood — were not patentable because they describe laws of nature.
Columbia University's trustees are suing Illumina, claiming infringement of five patents covering methods for next-generation sequencing. In the lawsuit filed in US District Court for the District of Delaware, Columbia alleges Illumina infringed on patents covering DNA-sequencing-by-synthesis technologies.
Harold Garner is stepping down from his role as executive director of the Virginia Bioinformatics Institute, which he has led since 2009. Garner will now head VBI's Medical Informatics Systems division and focus on research. Dennis Dean, executive director of the school's Fralin Life Science Institute, will be the interim executive director.
Stephanie Astrow is the new vice president of research and development at molecular diagnostics firm Response Genetics. Astrow was previously the scientific director for oncology at Quest Diagnostics.
Hulin Wu will be the founding director of the University of Rochester Medical Center's Center for Integrative Bio-informatics and Experimental Mathematics. Wu is a professor of biostatistics and computational biology.
The US Presidential Commission for the Study of Bioethical Issues is studying the ramifications surrounding the use of human genome sequencing in research and medicine. The panel is seeking comment from the public and stakeholders about these technologies.
The New York Genome Center plans to use its new $3 million grant from the Alfred P. Sloan Foundation to recruit bioinformatics and sequencing specialists.
PerkinElmer is suing Agilent for infringing two patents covering mass spectrometry technology. Both patents were issued to John Fenn, Chin-Kai Meng, and Matthias Mann. Initially assigned to Fenn, the patents were subsequently assigned to Yale University, which then granted an exclusive license to Analytica, a firm PerkinElmer acquired in 2009.
CombiMatrix announced that Richard Hockett is the company's new medical director. Hockett was previously the chief medical officer of Affymetrix.
GE Healthcare purchased contract research organization SeqWright. The deal, GE said, is expected to complement its Clarient business, allowing the molecular diagnostics firm to expand its clinical diagnostics offerings to include next-generation sequencing.
Gary Gibbons is to be the new director of the US National Institutes of Health's National Heart, Lung, and Blood Institute, taking over this summer. Gibbons is the founder and director of the Cardiovascular Research Institute and currently the chair of the physiology department at the Morehouse School of Medicine.
David Schwartz, the founder of Bio-Rad Laboratories, has died. He was 88. Schwartz was the president, CEO, and chairman of the firm from 1957 until 2003 when his son, Norman Schwartz, succeeded him.
Kris Vanhercke is Biogazelle's new chief operating officer. Vanhercke has held a number of positions within Roche Diagnostics.
Kevin Fickenscher is the new president and CEO of the American Medical Informatics Association. He replaces Ted Shortliffe.
Joseph Beechem has left his position at Life Technologies to join NanoString as senior vice president of research and development.