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Applied Biosystems, FDA, Roche, Gen-Probe, GeneScan Europe, GenData, Amgen, Norak Biosciences

ABI Upgrades Panther Database, Opens it for Public Use

Applied Biosystems this week rolled out version 5.0 of its Panther database and made it free for public access after previously charging a fee for the online product.

The upgraded Panther database includes new tools for associating proteins, and gene expression data, with biological pathways. The product’s pathway module is the result of an ongoing collaboration with the Systems Biology Institute in Tokyo, led by Hiroaki Kitano, a founding member of the Systems Biology Markup Language consortium.

The Panther system will be integrated into the InterPro database of the European Bioinformatics Institute in February, ABI said.

FDA Publishes PGx Guidance in Federal Register; Final Document Now Due Early in 2005

The US Food and Drug Administration published its draft Guidance for Industry on Pharmacogenomics Data Submissions in the Dec. 27 Federal Register, and now expects to release the final guidance “early next year,” according to an FDA spokesperson.

The widely anticipated document, whose approval has been delayed numerous times since it was released as a draft in November 2003, is designed to encourage drug makers to use pharmacogenomics technologies in their drug-discovery efforts and submit some of their findings as a way to help the FDA broaden its knowledge of the technologies.

The document will be “out by January 2005,” said Larry Lesko, director of the FDA’s Office of Clinical Pharmacology and Biopharmaceuticals.

The guidance will appear on a special FDA website upon release, along with a companion Manual of Policies and Procedures and “frequently asked questions” documents, said Lesko. He did not disclose the website address.

FDA Clears Roche’s AmpliChip, Affy’s Reader, for IVD Use

The US Food and Drug Administration in December cleared Roche’s AmpliChip CYP450 DNA chip and Affymetrix’s GeneChip 3000Dx chip reader as an in vitro diagnostic.

The approval, announced in an FDA statement on Dec. 23, marks the first time that a microarray instrument and chip has won FDA clearance for IVD use. The agency also said the clearance may open the door for additional molecular diagnostics based on microarrays to be sold nationwide.

Gen-Probe Licenses AdnaGen’s Tumor Cell Detection Technology

Gen-Probe has licensed a tumor cell detection technology from AdnaGen of Germany, the San Diego-based company said this week.

Under the terms of the agreement, Gen-Probe obtains exclusive access to AdnaGen’s technology for molecular diagnostic tests for prostate and bladder cancer. Gen-Probe will pay AdnaGen license fees of $1 million, as well as $750,000 in the first quarter of 2006 or when AdnaGen’s patent issues, whichever happens later. Gen-Probe may also pay AdnaGen three milestones totaling an additional $2.25 million. In addition, AdnaGen will receive royalties on sales of products developed using its technology.

Gen-Probe also obtains options to exclusively license the technology for kidney, ovarian, and cervical cancer. Also, the company has a three-year right of first refusal for using the technology for breasts, colon, and lung cancer tests.

GeneScan Takes 25.1 Percent Stake in MWG

GeneScan Europe has acquired 25.1 percent of MWG Biotech pursuant to a stock-purchase agreement with two major shareholders announced last month, the company said last week.

Specific details of the sale, which included 8,656,500 shares of MWG, were not disclosed.

GeneScan also has purchased about €2 million in MWG convertible bonds from the shareholders.

MWG Biotech said separately that it has sold convertible bonds totaling €6.5 million. Proceeds of the sale will be used to support MWG’s ongoing restructuring, the company noted.

GenData and Amgen Sign Drug-, Diagnostic-Development Partnership

GenData and Amgen will partner to develop drugs and diagnostics for an undisclosed disease, GenData said this week.

Under the collaboration, Amgen will select genetic targets identified by GenData's population genetics discovery platform, based on the Utah Genetic Reference Product and the Utah Population Database. The drug maker will also pay GenData for "research activities, product-development milestones," and for products developed, according to GenData.

Norak Changes Name to Xsira, Plans Sale of Fluorescent Assay Technology

Norak Biosciences said this week that it has changed its name to Xsira Pharmaceuticals to reflect its transition from a platform technology company to a product development company. As part of the change, Norak also plans to sell all aspects of its business related to Transfluor, its fluorescent assay technology for screening G-protein coupled receptors.


The Scan

Self-Reported Hearing Loss in Older Adults Begins Very Early in Life, Study Says

A JAMA Otolaryngology — Head & Neck Surgery study says polygenic risk scores associated with hearing loss in older adults is also associated with hearing decline in younger groups.

Genome-Wide Analysis Sheds Light on Genetics of ADHD

A genome-wide association study meta-analysis of attention-deficit hyperactivity disorder appearing in Nature Genetics links 76 genes to risk of having the disorder.

MicroRNA Cotargeting Linked to Lupus

A mouse-based study appearing in BMC Biology implicates two microRNAs with overlapping target sites in lupus.

Enzyme Involved in Lipid Metabolism Linked to Mutational Signatures

In Nature Genetics, a Wellcome Sanger Institute-led team found that APOBEC1 may contribute to the development of the SBS2 and SBS13 mutational signatures in the small intestine.