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ClinXus, Critical Path Institute, GATC Biotech, LifeCode AG, Center for Molecular Medicine, Children’s Oncology Group, University of Pittsburgh, WaferGen, Third Wave Technologies, Inverness Medical Iberica, Osmetech, Prodesse, Luminex

ClinXus Becomes First Non-Profit Member of C-Path Institute Safety Consortium
ClinXus announced this week that it has become the first non-profit organization to join the US Food and Drug Administration’s Critical Path Institute’s Predictive Safety Testing Consortium.
The Grand Rapids, Mich.-based life-sciences alliance, formed in July 2006 with a $1.5 million grant from the Michigan 21st Century Jobs Fund, is focused on developing “innovative clinical trials that are primarily biomarker driven,” the company said in a statement. The alliance’s members include the Van Andel Institute, Spectrum Health, Saint Mary’s Health Care, Jasper Clinical Research & Development, Grand Valley State University, and Grand Valley Medical Specialists.
Critical Path Institute, established in 2005 as part of FDA’s Critical Path Initiative, is a non-profit that helps facilitate collaborative research and education programs to accelerate product development by identifying development problems and opportunities for improvement. The PSTC convenes pharmaceutical companies so that they can validate each other’s safety testing methods with guidance from the FDA and the European Medicines Agency.
“The PSTC has been described as a model for modernizing the development of medicinal products,” said Craig Webb, ClinXus board president, and Van Andel Institute’s scientific investigator and director of translational medicine. “It allows pharmaceutical companies and partners to share knowledge and resources to bring life-saving drugs to the FDA more quickly and safely.”
While initially PSTC mainly involved big pharma companies, including Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Novartis, Pfizer, Roche, and Schering Plough, the addition of the first non-profit member signals that the effort is advancing successfully. 
“The PSTC has made rapid progress since its inception last year and this is a testimony to the commitment and willingness of the member companies to share their testing methods and data,” PSTC Director William Mattes said in a statement. “We have already found a number of improved tests for drug safety that can be used in the early stages of drug development. ClinXus will greatly facilitate the next phase that includes clinical evaluation of these new tests.”

GATC Forms Consumer Genomics Subsidiary LifeCode; Pitches 'Medical Context' of Service
Genomic services provider GATC Biotech has jumped into the consumer genomics market with a new subsidiary called LifeCode AG, the company said this week.
LifeCode, which is expected to begin offering DNA sequencing and analysis services to customers in April, will focus on placing an individual’s genomic data in a “medical context,” GATC said.
LifeCode plans to present this information in “a reliable and lucid platform for medial consultation, guaranteeing at the same time the maximum possible level of data security,” the parent company said.
GATC, based in Constanz, Germany, said that LifeCode will be the “first web-based information service for the storage and utilization of biological and medical data from the analysis of genetic codes and protein codes in the EU.”
The company faces competition from a number of other firms that have recently entered the consumer genomics market, including Iceland’s DeCode Genetics and US-based companies such as Navigenics, 23andMe, and Knome.
GATC did not provide details of the type of genomic analysis that LifeCode will provide or the cost of the service.
DeCode and 23andMe, which are offering SNP-genotyping analysis, are charging around $1,000 for their services, while Navigenics is also marketing a genotyping-based service priced at around $2,500.
Knome, which is offering whole-genome sequencing, is charging around $350,000 for its service.
LifeCode plans to deliver a platform “with which each person can record and manage his or her personal biological code,” while placing the customer’s genetic profile into a “scientific and medical context,” GATC said.
The spin-off will be run by GATC’s CEO, Peter Pohl.
“One major concern of LifeCode is to ensure that every customer is able to make an informed decision in respect of biological tests, and that no examinations are undertaken under any incorrect understanding, without explanation and without the customer’s informed agreement,” Pohl said in a statement.

Center for Molecular Medicine to Provide Genotyping Services for COG Leukemia Study
The Center for Molecular Medicine will provide genotyping and analysis services to the Children’s Oncology Group to support a study of genetic abnormalities and their association with response to therapies for treatment of childhood leukemia, CMM said this week.
CMM, based in Grand Rapids, Mich., said that in the first phase of the study it will analyze up to 2,200 matched samples of DNA from pediatric leukemia patients’ blood samples and their leukemic blasts. The aim is to identify and catalog genetic variations that COG can use in its efforts to develop improved diagnostics and therapeutics for childhood leukemia.
CMM will “identify and catalog about a million key SNPs” in these samples, said CMM executive director Daniel Farkas.
CMM said it will begin testing samples this month, and that Phase I may be completed by spring.
COG and CMM are also “working together to identify sources of funding to expand the study to six to eight thousand more specimens,” CMM said in a statement.
Financial terms of the agreement were not released.
CMM is a clinical diagnostics laboratory formed last year as a joint venture between Spectrum Health and Van Andel Institute.

University of Pittsburgh to Test WaferGen's Real-Time PCR System, Oncology Assays
WaferGen said this week that the University of Pittsburgh Medical School has agreed to alpha-test its SmartChip Real-Time PCR System and several oncology gene panel assays for the system.
WaferGen said the SmartChip Real-Time PCR System is a whole-genome gene expression platform that “promises to deliver significant speed and cost advantages to researchers in the gene expression and genotyping markets.”
The company said the system can conduct 33,750 assays on a chip, as compared to 384 assays per plate for standard real-time PCR technologies.
Researchers at the University of Pittsburgh Medical School plan to use the system to identify biomarkers for chronic obstructive pulmonary disease and lung cancer.
WaferGen said it is developing additional assays for the system, including toxicology assays, and that it is also developing a higher-throughput version of the system that will allow users to conduct 100,000 assays on a chip.
This capability will allow users to use one chip to conduct whole-genome gene expression in triplicate, the company said.

Third Wave Signs Partners to Distribute HPV Test in Spain, Portugal, and Italy
Third Wave Technologies said this week that Inverness Medical Iberica, a Spanish affiliate of Inverness Medical Innovations, will distribute its human papillomavirus screening test in Spain and Portugal.
Third Wave also said it has signed agreements with four “well-known regional distributors” to distribute its HPV product in Italy, though it did not identify those firms.
“We continue to negotiate with potential distributors for each of the other major markets in Europe and look forward to having them in place soon," said Kevin Conroy, president and CEO of Third Wave, in a statement.
Third Wave’s HPV test gained European CE Marking certification in December.
The company’s test detects the presence of 14 high-risk types of HPV, the virus that causes nearly all cervical cancers.

Osmetech Submits Warfarin Sensitivity Test to FDA
Osmetech said this week that it has submitted to the US Food and Drug Administration a test to identify patients who are at risk for sensitivity to the blood-thinner warfarin.
Osmetech said it conducted studies for the eSensor 2C9/VKOR test on its eSensor XT-8 tool at three evaluation sites, and that pre-clinical studies completed in November 2007 showed the test to be in agreement with results from bidirectional DNA sequencing.
In August, the FDA updated its label for warfarin to explain that an individual’s genetic makeup may influence response to a drug and may influence optimal dosing.
Osmetech’s CEO, James White, said the company is confident that it will receive clearance from the FDA for the test in the first half of this year.
The FDA in September cleared a test for warfarin sensitivity made by Nanosphere.

FDA Clears Prodesse RT-PCR Flu Test
Prodesse has received US Food and Drug Administration clearance to market its real-time PCR-based flu test, the company said last week.
The firm’s ProFlu Assay is designed to simultaneously detect and differentiate influenza A and B viruses and respiratory syncytial virus, and provides results in around three hours.
Prodesse said other tests are on the way, including one for human metapneumovirus that is in clinical trials now and another to differentiate parainfluenza viruses that is soon to begin clinical trials.
The company claims that its real-time PCR-based test would provide advantages, such as reduced hands-on time, elimination of amplicon contamination, and relatively low equipment costs, over other molecular diagnostic technologies including microbeads and microarrays.

FDA Clears Luminex's MDx Respiratory Viral Panel
The US Food and Drug Administration has cleared Luminex’s molecular diagnostic panel for a dozen viruses that account for over 85 percent of respiratory viral infections, including various influenza strains, the company said last week.
The xTAG Respiratory Viral Panel, made by Luminex Molecular Diagnostics in Toronto, is based on Luminex's xMAP technology. The firm had expected to receive FDA clearance of the panel this past fall, but the process took longer than expected, which Luminex CEO Patrick Balthrop in October attributed to the filing being a de novo submission of “the first product of its kind.”
Using one swab sample, the xTAG can identify three types of Influenza A, a strain of influenza B, as well as adenovirus, respiratory syncytial virus A and B, Metapneumovirus, Parainfluenzas 1, 2, and 3, and rhinovirus, which causes the common cold. 
Current tests for some of these viruses can take several days to provide a thorough diagnosis, the company said.
Luminex’s CEO Patrick Balthrop said the FDA’s 510(k) clearance of the test can help improve virus surveillance in and out of the hospital and can “significantly improve patient care.”
During a conference call last week, Balthrop said, “This test has the potential to completely change the way respiratory disease is diagnosed. xTAG RVP offers physicians and patients a level of information to assist them in comprehensive diagnosis that just has not been possible before.”
Respiratory viral infections are the seventh leading cause of death in the US, killing 60,000 people per year, and are responsible for 75 percent to 80 percent of doctor visits.
The availability of a test for all of these respiratory viruses can both speed up and improve doctor care and could help lower the overuse of antibiotics, which has been implicated in the development of antibiotic-resistant bacteria, the company said.
The panel is being sold by LMD and its distribution partner, Thermo Fisher Scientific unit Fisher HealthCare, through an agreement inked last January. It already has the CE mark, allowing the panel to be sold throughout the European Union.
The xTAG RVP Panel that has been cleared for sale in Europe has 19 assays as opposed to the 12 on the version cleared here in the US. Luminex had initially been discussing with the FDA including all 19 targets on the product.

“The difference between those roughly seven viruses are viruses that are relatively rare,” Balthrop said during the call. “We cover 85 percent of all respiratory viral infections” in the US in the xTAG RVP Panel, he said.

“If we were to add the other seven that are available in the product that has been cleared by European regulatory authorities that number would increase to the low 92 percent range or so,” he added.

Balthrop also noted that the RVP panel is the firm’s first molecular diagnostic product to gain FDA clearance since it purchased Tm Biosciences in a $44 million stock-for-stock deal last March and renamed the firm Luminex Molecular Diagnostics.

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