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Rules-Based Medicine, EMD Chemicals, Luminex, Gene Logic, Nanogen, CDC, Clinical Data, Merck KgaA, TrimGen, FDA, Beckman Coulter, Thomas Jefferson University, Laboraf Diagnostica e Ricerca San Raffaele, Third Wave Technologies, NCI

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Rules-Based Medicine, EMD To Co-Develop Protein Multiplex Assays for xMAP
 
Rules-Based Medicine and EMD Chemicals said this week that they are partnering to develop and distribute immunoassay products for use on Luminex’s xMAP platform.
 
Under the terms of the agreement, biomarker testing firm RBM is providing EMD, a subsidiary of Germany’s Merck, exclusive distribution rights to its catalog of quantitative protein multiplex assays.
 
EMD will market RBM’s testing content in co-branded multi-analyte kits under its Novagen brand.
 
The kits will be available in the middle of 2008 and will be marketed to pharmaceutical and biotechnology companies and universities.
 
The agreement follows EMD’s announcement last week that it had signed a deal with Luminex to use the xMAP platform for multiplex immunoassays.
 

 
Gene Logic Shareholders OK Sale of Genomic Business, Name Change
 
Gene Logic said this week that its shareholders have approved the sale of its genomic assets to Ocimum Biosolutions, as well as its transformation into a drug repositioning firm with the new name of Ore Pharmaceuticals.
 
Gene Logic announced its plans to change its focus and its brand in late October, after it struck a deal with Ocimum to sell its genomics business for $10 million.
 
Ocimum will own the Gene Logic name. The company's stock will continue to trade on the Nasdaq exchange under a new ticker symbol, ORXE.
 
"As a drug repositioning and development company, our sole purpose is to supply the demand of pharmaceutical companies for product innovation to enrich their development pipelines," said Gene Logic's CEO, Charles Dimmler, in a statement.
 
The company said it expects to close the sale of its genomics business to Ocimum by the end of this week.
 

 
Nanogen Submits Prototype of Rapid Flu Dx to CDC
 
Nanogen has submitted an influenza diagnostic to the US Centers for Disease Control and Prevention for evaluation for further development, the company said this week.
 
Nanogen said this submission fulfills a second-phase milestone requirement on a contract CDC awarded to Nanogen and its business partner, the San Francisco-based HX Diagnostics.
 
The company said it will continue to develop the point-of-care influenza diagnostic and will undertake clinical trials pending approval and funding from the CDC.
  
Around 36,000 people in the US die each year from influenza infections, the company said.
 
The CDC is concerned about the possibility of a deadly influenza subtype arising and causing a pandemic and is funding development of tests that can act as “sentinels” for potential outbreaks, Nanogen said.
 

 
Clinical Data Makes Milestone Payment to Germany's Merck
 
Clinical Data said this week it has paid out 135,146 of its shares to Merck KGaA as a milestone payment after successfully completing a Phase III study of the German firm’s Vilazodone drug.

Clinical Data’s shares closed most recently at $24.22.

Clinical Data acquired the rights to antidepressant Vilazodone in 2004 and is developing the drug along with a genetic test that will help doctors match patients with a treatment that is most likely to work in the first instance.

 

 
TrimGen Seeks FDA Clearance for Warfarin PGx Kit
 
Molecular diagnostics firm TrimGen said last week that it has filed with the US Food and Drug Administration for 510(k) clearance of its diagnostic kit to aid physicians in prescribing the anticoagulant warfarin.
 
The firm’s eQ-PCR LightCycler Warfarin Genotyping Kit identifies certain SNPs in the CYP2C9 and VKORC1 genes, which serve as clinically relevant predictors of warfarin response. The test is run on Roche’s LightCycler platform.
 
According to Sparks, Md.-based TrimGen, results of more than 5,000 tests during clinical trials showed 100 percent agreement between its warfarin kits and the corresponding bi-directional sequencing method.
 
Several firms sell home-brew molecular diagnostic ASRs for warfarin dosing, and many have said they would seek FDA clearance for their tests.
 
Thus far, Nanosphere is the only firm to receive FDA clearance of a test for warfarin sensitivity. Nanosphere’s Verigene Warfarin Metabolism Nucleic Acid Test, which runs on the company’s Verigene platform, was cleared in September and also detects some variants of the CYP2C9 and VKORC1 genes.
 
In August, the FDA updated labeling for warfarin with information explaining that people with variations in CYP2C9 and VKORC1 may respond differently to the drug. The agency, however, stopped short of requiring physicians to genetically test their patients, noting that additional outcomes studies needed to be done.
 

 
Beckman Coulter Teams with US, Italian Researchers for CVD, Hypertension Signatures
 
Beckman Coulter has started a research collaboration with Thomas Jefferson University of Philadelphia and the Laboraf Diagnostica e Ricerca San Raffaele in Milan, Italy, aimed at researching genetic signatures for cardiovascular disease and obesity-related hypertension.
 
Under the collaboration, the universities and the company will use the company's Biomek FXP Laboratory Automation Workstation and GenomeLab SNPStream Genotyping System to develop research protocols and assays. Beckman Coulter will have the right to exclusively license commercial applications that result from the collaboration.
 
Beckman intends to use the genetic signatures discovered in the alliance to develop content for its next-generation molecular diagnostics platform, which it plans to launch in 2010.
 
“The discovery of genetic factors for both CVD and obesity may lead to development of readily-accessible diagnostic tests that enable more rapid assessment, earlier treatment, and preventive measures,” Bruce Wallace, president of Beckman Coulter’s molecular diagnostics business center, said in a statement.
 

 
EU Clears Third Wave's HPV Test; Sales to Start after New Year
 
Third Wave Technologies’ HPV test has received CE Marking from European regulators, the company said last week.
 
The clearance from the European Union gives the company the green light to sell the test, which detects 14 high-risk types of HPV and is used in screening for cervical cancer, in EU member nations and in other nations that recognize the CE mark.
 
The company said it expects to market the test in Europe in January 2008.
 

 
NCI Offers Prostate Cancer Genotyping Predictive IP
 
The National Institutes of Health is making a prostate cancer-related genotyping technology available for either exclusive or non-exclusive licensing.
 
The National Cancer Institute’s Medical Oncology Branch is seeking interested research collaborators to develop, evaluate, or commercialize this technology, which is used to predict survival prognoses for prostate cancer patients.
 
The NCI’s genotyping technology identifies two polymorphic genetic markers in the SLCO 1B3 gene that can be measured in DNA from a blood sample.
 
The inventors have provided a correlation between clinical outcomes of SLCO 1B3 genotype with median survival of androgen-independent prostate cancer. They also have shown that the genotype can help predict testosterone uptake, which can be helpful knowledge in making clinical decisions.
 
Additional information about the technology is available here.

Filed under

The Scan

Gone, But Now Reconstructed SARS-CoV-2 Genomes

In a preprint, a researcher describes his recovery of viral sequences that had been removed from a common database.

Rare Heart Inflammation Warning

The Food and Drug Administration is adding a warning about links between a rare inflammatory heart condition and two SARS-CoV-2 vaccines, Reuters reports.

Sandwich Sampling

The New York Times sent tuna sandwiches for PCR analysis.

Nature Papers Describe Gut Viruses, New Format for Storing Quantitative Genomic Data, More

In Nature this week: catalog of DNA viruses of the human gut microbiome, new dense depth data dump format to store quantitative genomic data, and more.