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CMS Says Genetic-Testing Specialty Under CLIA Rules 'Forthcoming'

The Centers for Medicaid and Medicare said this week that a genetic-testing-specific set of standards is currently in clearance at the agency.

"There will be a regulation forthcoming," a CMS official told Pharmacogenomics Reporter sister publication GenomeWeb News this week. "It is a proposed rule that will solicit comments from the public."

There is currently no genetic testing specialty under the Clinical Laboratory Improvement Amendments. As GenomeWeb News reported last week, the Genetic Alliance urged CMS to establish such a specialty as proposed by the Centers for Diseases Control and Protection in 2000.

The CMS official told GenomeWeb News that the proposal would now be vetted by CMS, the CDC, the Office of Management and Budget, Health and Human Services, and the Food and Drug Administration.

The official could not give a timeline for clearance of the rule.


Applera Withdraws Its Opposition to Affy Patents in Europe

Applied Biosystems parent Applera this week withdrew its opposition to an effort by Affymetrix to enforce a patent the European Patent Office revoked in its entirety one year ago, according to an EPO database.

The patent in question, "Methods using nucleic acid hybridization patterns on a matrix of oligonucleotides" (EP0834576), was initially granted to Affymetrix on Nov. 28, 2001, and published in the European Register the following month.

The patent was revoked last year, however, after Applera, CombiMatrix, Abbott Laboratories, PamGene, and others successfully opposed it through the EPO's opposition division.

Affy appealed the EPO's decision in July 2005, after which Applera and other opponents continued to oppose Affy's rights to enforce the '576 patent.

But according to online EPO records, Applera withdrew its opposition to the '576 patent last week, and also withdrew its opposition to three other Affy patents last month.

Applera was the only party opposing "Method of forming arrays of polymers" (EP0972564), but other parties will continue to oppose "Identification of nucleic acids in samples," (EP0834575) and "Expression monitoring by hybridization to high density oligonucleotide arrays" (EP0853679), as well as the '576 patent, according to the database.

In December, ABI announced that it had licensed several of Affymetrix's microarray patents, but the companies have not disclosed the terms of the licensing agreement.

The patent attorney representing Applera in the case declined to comment.


Proteome Systems and Egenix to Develop Semen-Screening Diagnostic for Prostate Cancer

Proteome Systems and Egenix will co-develop a semen-based diagnostic kit for prostate cancer, Proteome Systems said this week.

The non-invasive test will be based on the human carcinoma antigen.

Under the agreement, Egenix will fund research to optimize the detection of HCA in semen of prostate cancer patients. The companies will then share the rights for further development and commercialization of the test.

Egenix estimated a potential US market size for the HCA test of up to $1.5 billion, according to a statement.

"We initially wondered if there would be social or cultural objections to a test that requires the patient to provide an ejaculate specimen," said Egenix president Jedd Levine. "But it's common to look in organ secretions for signs of cancer in that organ and ... most men would willingly provide a semen specimen to potentially avoid a painful needle biopsy."


Decode Logs 13-Percent Drop in Q4 Revenues amid Swelling R&D Costs and Loss

Decode Genetics this week reported an approximately 13-percent decrease in revenues amid escalating losses for the fourth quarter.

Decode's revenues for the three months ended Dec.31, 2005, dropped to $9.8 million from $11.2 million year over year.

Research and development expenses increased nearly 60 percent to $13.7 million for the fourth quarter from $8.7 million for the same period in 2004, Decode said, primarily to support its drug-development programs.

The company's net loss grew to $21.1 million from $19.4 million in the year-ago period. Decode attributed the spike in net loss to the increased R&D expenses.

Decode had $155.6 million in cash and investments on hand as of Dec. 31.


NIH Awards $16.5M to Vermont Genetics Network to Support Array, Proteomics Facilities

The National Institutes of Health's National Center for Research Resources has awarded a $16.5 million grant to the University of Vermont to fund the Vermont Genetics Network, UVM said this week.

The grant will help support microarray and proteomics facilities, as well as a bioinformatics core, UVM said. In addition, the grant will help build biomedical research funding competitiveness at UVM by providing research support to early-career faculty and graduate students, the university said.

Established in 2001 through a $6-million NCRR grant, the VGN is a multidisciplinary scientific research network designed to build and strengthen biomedical research and expertise throughout the state. Led by UVM, the network also includes Castleton State College, Johnson State College, Middlebury College, Norwich University, and St. Michael's College.

At the state level, 60 percent of the total VGN grant funds are distributed from UVM to the partner institutions. At the national level, VGN joins a system of university and college networks funded by NCRR called the IDeA Networks of Biomedical Research Excellence.


Cepheid to Use Cash from Recent Stock Offering to Invest in Molecular Dx

Cepheid will use proceeds from a recently announced stock offering to invest in its molecular diagnostics program, according to prospectus filed with the Securities and Exchange Commission this week.

In the document, Cepheid reports that it expects the net proceeds from the offering will be approximately $80.5 million, and that the company plans to use the cash to "fund future acquisitions of molecular markers and/or complementary products, technologies or companies in the fields of oncology, infectious diseases and other fields appropriate for molecular diagnostics."

Still, Cepheid said that it has "no current agreements or commitments with respect to any such acquisition" pending and that fore now it will invest the funds in "short-term, investment grade, interest-bearing securities."

The company disclosed in a Feb. 24 SEC filing that it plans to offer to the public 10 million shares of common stock, plus an option to purchase up to an additional 1.5 million sharees to cover over-allotments.


Wyeth Research Expands PGx Contract with Expression Analysis

Wyeth and Expression Analysis have expanded their July 2004 pharmacogenomics testing services agreement, Expression Analysis said last week.

The microarray services firm will use the Affymetrix GeneChip platform and will be compliant with 21 CFR Part 58, the company said in a statement.

Financial details were not provided.


DNAPrint to Work with Mass University to Develop Ritalin-Like Compounds

DNAPrint Genomics will help the Massachusetts College of Pharmacy and Health Sciences develop Ritalin-like compounds, the company said last week.

The research will be conducted under the supervision of Mark Froimowitz, a researcher at the Boston-based university, who recently licensed Ritalin analogs to DNAPrint. The compounds were developed as possible medications for drug abuse, attention deficit hyperactivity disorder, and depression.

DNAPrint will work with Froimowitz to develop theranostic tests based on the compounds, said Hector Gomez, DNAPrint's chairman and chief medical officer.


Tepnel Completes Acquisition of GenXTrak DNA Extraction Buisiness

Tepnel announced last week it has completed the acquisition of the GenXTrak DNA extraction business from Whatman for an undisclosed sum.

The Cambridge, UK- based business will now operate within Tepnel's service division.

n a statement, CEO Ben Matzilevich said the new unit would help provide genetic and protein analysis capabilities that will be expanded to facilities in Edinburgh, Scotland, and US facilities.


Liotta and Petricoin, Italian Health Agency to Identify Proteomic Biomarkers, Drug Targets for Cancer

George Mason University and the Instituto Superiore di Sanitá in Rome plan to develop a proteomics research program to discover new drug targets and biomarkers for early cancer detection, the organizations said last week.

The research will be led by center co-directors Lance Liotta and Emanuel Petricoin through the George Mason University's Center for Applied Proteomics and Molecular Medicine, the statement said.

The ISS, which is the main scientific arm of the Italian National Health Service, will provide Mason with human tissue and blood samples, funding for Italian and Mason scientists to work at the CAPMM laboratories, and access to research from a consortium of Italian cancer centers, the statement added.

Specific collaborative initiatives include nanotechnology development; identification of new bloodborne biomarkers for early detection of ovarian, colorectal, lung, and breast cancers; discovery of new drug targets for advanced stages of colorectal, lung, and breast cancers; and discovery of new drug targets for childhood leukemia, childhood cancers, and brain cancers, the partners said.

The agreement represents a continuation of a US National Cancer Institute project Liotta, Petricoin, and the ISS worked on to develop proteomics technologies for analysis of cancer and other diseases.


Gene Express Joins FDA's Microarray Quality Control Program

Gene Express will participate in the US Food and Drug Administration's Micro Array Quality Control Consortium, the company said last week.

Under the agreement, Gene Express will analyze samples with its StaRT-PCR technology.

Other members of the consortium include the National Institutes of Health, the National Cancer Institute, the Environmental Protection Agency, the National Institute of Standards and Technology, Affymetrix, GE Healthcare, Applied Biosystems, Agilent, Eppendorf, Genospectra, Illumina, Biogen, and Novartis.


Exagen Opens Sales Office in Austin, Texas

Exagen Diagnostics has opened a new business office in Austin Texas, the company announced last week.

The office houses the sales and customer care operations for the IVD developer and will allow the company to "take advantage of the city's biotech labor pool as we move toward commercializing our first products," Exagen CEO James McClintic said in a statement.


Korean NIH Partners with Affy for Genome-Wide Association Studies

Korea's National Institute of Health will use Affymetrix's Human 500K Mapping Set to perform genome-wide association studies in several disease areas, including diabetes, hypertension, and metabolic syndrome, Affy said this week.

According to Affymetrix, the Korean NIH will work with academic and industry partners to generate more than 10 billion individual genotypes from 20,000 human DNA samples to help identify the genetic causes of these diseases using Affy's technology.

Financial details of the agreement were not discussed.

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