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AT&T Foundation, Mayo Clinic, Clinical Data, Digene, Affymetrix, HealthCare, Clinical Data, GWU, Illumina

AT&T Foundation Gives Mayo Clinic $900K to Expand PGx Data Bank
The AT&T Foundation has given $900,000 to the Mayo Clinic to expand a data warehouse of patients’ clinical and genomic information, AT&T said this week.
The Mayo Clinic Life Sciences System, part of a Mayo Clinic collaboration with IBM, is a data warehouse and search engine that currently stores millions of patients' clinical and genomic data and identifies subsets of patients with specific genetic features and medical histories.
It is used as a reference for “accurately prescribing medical solutions for other patients with similar genetic profiles and medical backgrounds,” according to AT&T.
Mayo Clinic plans to use the funds to increase the MCLSS’s genomic and prescription data capacities and to make this information retrievable by Mayo Clinic scientists.

Clinical Data to Net $71.5M in Offering After Underwriters Exercise Over-Allotment
Clinical Data said this week that underwriters in a public offering that closed July 23 have exercised an over-allotment option to buy an additional 450,000 shares of the company’s common stock.
Clinical Data, which announced the shelf registration on July 9, said it expects to bring in aggregate net proceeds of $71.5 million after issuing the total 3.45 million shares in the offering.
Clinical Data will use the proceeds from the offering to fund clinical trials, preclinical R&D, and for corporate purposes such as acquisitions, capital expenses, and working capital.

California Court Tosses Gen-Probe Complaint Against Digene; Arbitration on HPVs Open
A California court has dismissed a complaint Gen-Probe filed against Digene last year over a 2005 agreement between Gen-Probe and Roche, Digene said this week.
Gen-Probe filed the complaint in a San Diego County court in December 2006 to counter claims by Digene that its agreement concerning human papillomavirus-related materials with Roche was not legal because Gen-Probe was not part of a pre-existing cross-license agreement between Digene and Roche.
In its decision, the court also gave Gen-Probe “no option to re-file” the complaint or amend it, Digene said.
Digene claims that Gen-Probe was not a party to the 1990 cross-license agreement between Roche’s predecessor, Institut Pasteur, and Digene’s predecessor, Life Technologies, that would grant it access to the HPV-related technology, and turned to that argument when it filed to have Gen-Probe’s claims dismissed from the San Diego Court in March.  
Digene has one HPV test that has received US Food and Drug Administration approval, and Gen-Probe is in the process of developing one.
Digene said the court decided that there is “no actual controversy between Digene and Gen-Probe.”
A separate ongoing proceeding promises to keep the HPV matter in play for now since a New York-based arbitration panel last week agreed to allow Gen-Probe to join a proceeding between Digene and Roche.  
Last week, Digene said it filed for the arbitration in December 2006 claiming that Roche had transferred to Gen-Probe human papillomavirus products under “the guise of a supply and purchase agreement.”
Michael Watts, Gen-Probe’s senior director of investor relations and corporate communications, told Pharmacogenomics Reporter sister publication GenomeWeb Daily News this week that the company filed the proceeding in December 2006 as “a parallel proceeding in case we weren’t included in the arbitration proceedings with Digene and Roche.”
“That’s really the dispute that we wanted to be a part of,” Watts added, saying that Digene requested that Gen-Probe not be included in the arbitration.
The San Diego County case “was for a summary judgment that our agreement in Roche was in fact valid,” Watts said.
Digene CEO Daryl Faulkner said in a statement his company is “very pleased with this result, and with the termination of this litigation.”

Affymetrix Expands Microarray Dx Pact With Partners HealthCare
Affymetrix this week said it has expanded a translational research alliance with Partners HealthCare and collaborators at Harvard University to include a contract array-manufacturing agreement, which will enable the companies to use custom chips made by Affy for lab-developed diagnostics.
Under the terms of the agreement, Affymetrix will create custom microarrays based on “recent discovery data” from Partners researchers. The arrays will be used to produce molecular diagnostics that will be validated and implemented in Partners HealthCare’s Clinical Laboratory Improvement Amendments-certified labs.
The team at Partners will begin focusing on array-based tests for hypertrophic cardiomyopathy, and will explore “many indications in a large number of diseases.”
Financial terms of the agreement were not released.

Clinical Data, GWU to Study Benefits of Using PGx to Dose Warfarin
Clinical Data’s PGxHealth division will work with clinical researchers at George Washington University to study the effectiveness of genomic testing to guide dosing decisions for the widely used anticoagulant warfarin, the company said last week.
The studies will use Clinical Data’s PGxPredict:Warfarin in a trial involving 80 post-surgical GWU patients to “evaluate the potential clinical, safety, and treatment-time benefits of using the genetic test to determine optimal warfarin dosing.”
Doctors at GWU’s Medical Faculty Associates Department of Orthopedic Surgery will conduct the study by using CD’s test to determine warfarin dosing in half of the subjects, the company said.  
If the program shows positive results, the company said GWU could incorporate the test into the clinic’s standard practices.
According to Clinical Data, the Clinical Pharmacology Subcommittee of the Food and Drug Administration’s Advisory Committee for Pharmaceutical Sciences said that “sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in CYP2C9 that lead to reduced activity and genotyping patients in the induction phase of warfarin therapy [which] would reduce adverse events and improve achievement of stable INR in patients with genetic variations in CYP2C9.”
Also, “sufficient mechanistic and clinical evidence exists to use lower doses of warfarin for patients with genetic variations in VKORC1 that lead to reduced VKORC1 activity and genotyping patients in the induction phase of warfarin therapy [which] would reduce adverse events and improve achievement of stable INR in patients with genetic variations in VKORC1.”

Illumina's Q2 Revenue, R&D More Than Double as Profit Jumps 37 Percent
Illumina this week said second-quarter revenues and R&D spending more than doubled over last year as profits jumped 37 percent.
Total receipts for the three months ended June 30 increased to $84.5 million from $41.6 million year over year.
Product revenues jumped to $74.3 million from $36.4 million, while service and other revenue increased to $10.1 million from $4.8 million year over year.
R&D spending swelled to $18.2 million from $8.6 million in the year-ago period.
Profit for the second quarter increased to $9.3 million from $6.8 million.
Illumina said it had around $343 million in cash, equivalents, and short-term investments as of June 30.
The company raised its expected full-year 2007 revenue to between $335 million and $345 million, which is $30 million higher than projections it made in April and as much as 86 percent better than 2006 receipts.
Third-quarter revenues are expected to be between $88 million and $92 million, or as much as 74 percent over the same period last year.

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