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LabCorp, Clinical Data, Mayo Clinic, Epidauros Biotechnologie, Boehringer Ingelheim Pharma, U Miami, Canon US Life Sciences, Caliper, GATC Biotech, XDx, Gentris

LabCorp to Offer Dx Testing to Customers at 20 Duane Reade Pharmacies in New York City
In a move that takes direct-to-consumer testing even closer to the consumer, LabCorp and pharmacy chain Duane Reade have penned an agreement that will place a LabCorp “patient service center” in 20 New York City Duane Read pharmacies.
The facilities will collect patient samples for nearly the full range of LabCorp diagnostics, including molecular diagnostics such as CYP450 testing, according to laboratory spokesperson Pam Sherry.
The service centers will be set up in a separate room of the pharmacy in which a LabCorp employee will collect common tissue or body fluid samples, such as cheek swabs or urine. From there the reference lab’s courier network will ferry the samples to the company’s testing facilities for examination, Sherry said.
Asked specifically whether molecular diagnostics procedures will be available through the sites, Sherry said that only tests that require special or difficult sample-collection procedures will be unavailable from the service centers. Molecular diagnostics generally require nothing more complicated than a blood sample.
The 20 service centers will open in “the next few months,” according to a press release from the two companies. LabCorp may later decide to expand its presence beyond the 20 locations to other Duane Reade stores and to other pharmacy chains, Sherry said.

Clinical Data, Mayo Clinic Swap UGT1A1 Patents
Clinical Data this week said the Mayo Foundation for Medical Education and Research has granted it a license for a variety of patents and patent applications to provide testing of the UGT1A1 gene.
The company also said it has exclusively licensed to Mayo Clinic certain of its own UGT1A1-related patent rights.
UGT1A1 is involved in metabolism of Camptosar, known generically as irinotecan, which is a commonly prescribed first-line treatment for advanced colo-rectal cancer.
Though effective, irinotecan can cause dangerous adverse events in as many as 30 percent of people who take it due to the inability to properly metabolize the drug. The FDA has recently revised the labeling for Camptosar to recommend reduced dosing in patients who test homozygous for the *28 variant of UGT1A1.

Boehringer Ingelheim Will Use Epidauros’ Technology to Help Populate Clinical Study
Epidauros Biotechnologie this week said that Boehringer Ingelheim Pharma has selected it as provider for genetic testing in a multicenter clinical trial.
The drug maker will use Epidauros’ process for genotyping in a planned multicenter clinical trial where a pharmacogenetic biomarker is analyzed as a main inclusion criterion for enrollment of patients into the clinical trial.
During the planned clinical trial, about 2,500 patients recruited at more than
80 sites among 13 countries will be tested for their compliance with a
predefined pharmacogenetic profile used as inclusion criterion.

U Miami to Open Human Genomics Institute in '07; Has Hired Heads of Duke's Genetics Center to Run It
The University of Miami may soon open an Institute of Human Genomics at or near the University’s Miller School of Medicine, the university said this week.
The university said that heading the institute will be Margaret Pericak-Vance and Jeffrey Vance, who are currently director and assistant director, respectively, of Duke University’s Center for Human Genetics.
The new institute, which is loosely scheduled to open in 2007, will focus on human genomics research and will use research and clinical departments at the Miller School. It also expects to have a Department of Human Genetics, but this hasn’t been finalized yet. 
Although many details of the institute have not yet been finalized or disclosed, Kelly Kaufhold, a spokesman for the medical school, said the Miller School has recently received a $100 million private endowment and will be given $800 million by the university, which recently raised $1.25 billion in a fundraising campaign.
Kaufhold said it had not yet been determined how much of this funding will go to the Genomics Institute, but the ground has been broken on campus for a new basic science center where the genomics facility may be housed until further plans are developed.
University president Donna Shalala, former Secretary of the Department of Health and Human Services under President Bill Clinton, said the institute will be “one of the premier institutes for human genomics in the world.”

Canon Will Use Caliper's LabChip Tech to Develop Screening, Dx Products
Canon US Life Sciences, a division of Canon USA, this week said it is using Caliper Life Sciences’ LabChip microfluidics technology and thermal analysis to develop genetic screening and diagnostic products.
Canon said it will use the technologies to shorten processing time and reduce the cost of gene diagnosis, and to enable rapid previews of genes for clinical use.
The microfluidics technology uses nanoliter-sized patient samples while the thermal melting analysis enables researchers to detect minute differences in specific genes. Canon said it expects these platforms to more precisely diagnose and screen samples.  
Canon said it hopes to use its optics and sensor technology in the future to develop life sciences technologies.
Financial terms of the agreement were not disclosed. Canon said it will present more information about the research at the International Conference on Miniaturized Systems for Chemistry and Life Sciences in Tokyo next week.
Last year shareholders of the camera and optics giant gave the company the green light to enter the microarray market and eventually become an in vitro diagnostics player.
As reported at the time by GenomeWeb News sister publication BioArray News, the shareholders approved an amendment to the firm's articles of incorporation that will enable Canon to move forward with its plans to produce and commercialize its own line of DNA chips.

GATC Will Use 454's GS20 to Sequence DNA and Transcriptomes, and Analyze Mutations
GATC Biotech will use 454 Life Sciences’ genome sequencing technology for its sequencing and analysis business, GATC said this week.
GATC, based in Konstanz, Germany, said that by adapting 454’s technology with traditional Sanger technology it can cut the sequencing and analysis time in half and reduce costs.
The company also said it will use 454’s instrument to sequence whole transcriptomes and for in-depth analyses of rare mutations.
GATC said using 454’s technology has boosted its own sequencing capacity to 15.6 gigabases per year.
Financial terms of the agreement were not disclosed.

XDx Announced Expanded Us of Test, New Reimbursement Approval
Molecular diagnostics company XDx this week announced expanded use and reimbursement for its AlloMap molecular expression test.
The AlloMap test is a non-invasive method to detect the absence of acute cellular rejection in heart transplant recipients. Data from a recent study show that it can now be used as early as two months post-transplant to rule out rejection.
Additionally, patients who are greater than 2 months but fewer than 6 months post-transplant who have an AlloMap test score below 20 are believed to be free from acute cellular rejection for 80 days.
This information could “help physicians to individualize or tailor patient care, reduce invasive monitoring (biopsies) and their risk of complications, and thereby, improve patient safety,” XDx said in a statement.
In the same statement, the company said that the California Medicare contractor National Heritage Insurance Company will reimburse for the AlloMap test. The decision covers tests submitted on or after Jan. 1, 2006.
Medicare bills for AlloMap testing are currently billed through NHIC because the test is conducted by XDx in its South San Francisco, Calif., clinical laboratory.

Gentris Files Six CYP450 Reference Controls for 510(k) Clearance
Gentris has submitted for 510(k) clearance six reference controls for the cytochrome P450 2D6 gene under the GentriSure brand.
The six products include: CYP2D6 *4A/*2AxN, CYP2D6 *29/*2AxN, CYP2D6 *2M/*17, CYP2D6 *3A/*4A, CYP2D6 *6B/*41 and CYP2D6 *1/*5 Human genomic DNA reference controls.
Gentris said its controls were tested on the Roche AmpliChip CYP450 test, which the FDA approved for CYP2D6 testing around two years ago.
The company said it has identified distributors for GentriSure controls in the US and Europe, and is currently seeking distribution partners in Japan. “The company anticipates this to be the first of many FDA 510(k) submissions including additional reference controls for other genes such as CYP2C19, CYP2C9 and VKORC1,” Gentris said in a statement. 
The GentriSure controls are available for research use only.

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