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Rosetta Biosoftware, FDA, Cepheid, Van Andel Institute, Spectrum Health, Illumina, Affymetrix

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C-Path’s Safety Consortium Adopts Rosetta Resolver System to Manage Drug Safety Data
 
Rosetta Biosoftware announced this week that the Critical Path Institute (C-Path) has adopted its Rosetta Resolver system for use in the Predictive Safety Testing Consortium.
 
The consortium will utilize the Resolver system as a central data management and analysis system in its efforts to develop standards for tests to evaluate the safety and toxicity of drugs submitted for FDA approval.
 
"The Resolver system has already played an important role in analyzing and maintaining gene expression data for the FDA's Voluntary Genomics Data Submission program,” William Mattes, director of the Predictive Safety Testing Consortium, said in a statement.
 
“Based on the reputation and performance of the Resolver system, the consortium determined that it will be a valuable tool for managing the toxicity and safety biomarker data of the consortium,” he added.
 
The consortium is a collaboration between major pharmaceutical companies, the C-Path Institute, and the US Food and Drug Administration to improve drug safety. Currently 16 industry members are participating in the consortium, including Abbott Laboratories, Amgen, AstraZeneca, Boehringer-Ingelheim, Bristol-Myers Squibb, Eli Lilly, GlaxoSmithKline, Iconix Biosciences, Johnson & Johnson, Merck, Genomics Institute of the Novartis Research Foundation, Pfizer, Roche Palo Alto Pharmaceuticals, Sanofi-Aventis, Schering Plough Research Institute, and Wyeth Pharmaceuticals.
 
Scientists from the FDA and the European Agency for the Evaluation of Medicinal Products are advisors in the program.
 

 
FDA Approves Cepheid's Meningitis PCR-Based Dx Test
 
The US Food and Drug Administration has cleared a Cepheid test designed to help physicians detect viral meningitis within two and a half hours, the FDA said last week.
 
Cepheid’s Xpert EV test is an automated diagnostic that uses reverse transcription PCR on cerebrospinal fluid samples to determine if a patient has enterovirus, which causes 90 percent of meningitis cases, the FDA said. The test runs on the company’s GeneXpert diagnostic system.
 
The FDA said that in a multi-site study the test was 96 percent accurate in detecting viral meningitis, and 97-percent accurate in patients who did not have the enterovirus.
 
Bacterial meningitis is far more lethal than the viral form of the disease, and requires swift diagnosis. Because symptoms of the two diseases are so similar, doctors currently treat viral patients empirically with antibiotics for the bacterial form.
 
Being able to swiftly determine which pathogen a patient has should allow doctors to make more accurate therapeutic decisions and avoid unnecessary antibiotic treatments, the FDA said.
 

Van Andel Institute, Spectrum Health Create Lab to Study Genomics, Proteomics of Disease
 
The Van Andel Institute and Spectrum Health have created a molecular technologies lab that will study genomics and proteomics for application in cancer, heart disease, mental illness, and other diseases, Spectrum Health said last week.
 
Spectrum, a non-profit group that operates seven hospitals in Western Michigan, said the Center for Molecular Medicine, located in Grand Rapids, has $6 million in funding.
 
The CMM will use Van Andel’s infrastructure and employees along with Spectrum’s clinical lab and research resources.
 
Van Andel CEO and Chairman David Van Andel said Spectrum has “a large patient population which allows us to apply what we're learning directly into the clinical setting."
 
The CMM will house and use DNA and RNA extraction, DNA microarrays, multiplex protein detection, and gene-expression profiling.
 
Directing the CMM will be Dan Farkas, who Spectrum said has established three other hospital-based molecular diagnostics labs.
 

 
Illumina Guilty of Infringing Five Affy Patents, Ordered to Pay $16.7M, Says it Will Appeal
 
A jury has found Illumina guilty of infringing five Affymetrix patents and has required it to pay Affy $16.7 million in royalties, according to a verdict delivered last week in a US District Court in Delaware.
 
Illumina plans to appeal. In a statement issued last week, Illumina CEO Jay Flatley said that the verdict was made "without consideration of the validity and enforceability of any of the patents asserted by Affymetrix" and is therefore "preliminary."
 
Flatley added that the case will now proceed to another phase, during which Illumina intends to prove that Affy's claims are "invalid and unenforceable." In the meantime, he said, "we will continue to sell the products that are the subject of this suit and no damages will be payable to Affymetrix until all appropriate appeals have been taken."  
 
Affymetrix sued Illumina in July 2004 for allegedly infringing six patents, but the company later dropped one from the case. Affy sought lost profits, royalties, damages for willfulness, and a permanent injunction that would prohibit Illumina from using the patented technology.
 
A Markman hearing later established 12 claims in the five patents where Illumina allegedly infringed on Affy’s IP.
 
The jury on March 12 found Illumina guilty of infringing 11 of the 12 claims but did not find that Affymetrix was entitled to the damages it sought. Instead it decided that Illumina must pay Affy a 15-percent royalty rate, which amounted to $16.7 million for sales through the end of 2005.
 
Flatley said that this amount is "less than half" the total amount of damages that Affy sought in the trial.

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