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DiaGenic’s Alzheimer’s Dx Inches Toward Market

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With an Alzheimer’s disease detection test it plans to market as a research-use-only assay by the end of the year, DiaGenic joins a number of molecular diagnostics firms hoping to capitalize on the advantages of blood-based testing.

DiaGenic’s blood-based gene-expression profile test, which will be validated on Applied Biosystems’ TaqMan platform, is an attempt to circumvent a problem that prevents conventional diagnostics from detecting Alzheimer’s: a doctor cannot directly sample a patient’s brain tissue.

Along with competitors such as DxS, Sequenom, Chondrogene, and researchers at Purdue University in West Lafayette, Ind., the firm is laying the groundwork for a diagnostic approach that may be useful in disease areas where tissue is not available for sampling.

DiaGenic says it validated its gene-expression profile in a sample of 125 newly diagnosed Alzheimer’s patients and 205 archival Alzheimer’s blood samples with an accuracy of 87 percent.

“The clinical validation — if everything works as we hope — should be started early next year,” says Anders Lönneborg, DiaGenic CEO. The company will submit its test to the US Food and Drug Administration for clearance within two or three years, he says.

There is no treatment tied explicitly to the results of DiaGenic’s test, but early detection might help clinicians decide whether to treat patients with drugs that slow Alzheimer’s symptoms. Such drugs include Pfizer’s and Eisai’s Aricept, which is an acetylcholine esterase inhibitor, and Namenda, an NMDA-receptor antagonist marketed in the US by Forest Laboratories. But there is not yet any reason to think that the test can identify patients who will respond well to an Alzheimer’s drug, says Lönneborg.

DiaGenic is still working on establishing the specific genes that will be validated with TaqMan, and the company is evaluating a range of platforms for the final product, says Lönneborg. The company “has not yet discussed” offering the test as an analyte-specific reagent in reference laboratories, but “that might be a possibility,” he adds.

— Chris Womack

PATENT WATCH

US Patent 7,078,481. Potassium channel interactors and uses therefor. Inventors: Kenneth Rhodes, Maria Betty, Huai-Ping Ling, and Wenqian An. Assignee: Wyeth and Millennium Pharmaceuticals. Issued: July 18, 2006.

This invention provides isolated nucleic acid molecules, called PCIP nucleic acid molecules, which encode proteins that bind potassium channels and modulate potassium channel-mediated activities. It also covers antisense molecules, expression vectors containing PCIPs, host cells for the vectors, and transgenics in which a PCIP gene has been introduced or disrupted.

US Patent 7,074,597. Multiplex genotyping using solid phase capturable dideoxynucleotides and mass spectrometry. Inventor: Jingyue Ju. Assignee: Columbia University. Issued: July 11, 2006.

According to the summary, this patent discloses an approach using ddNTPs for multiplex genotyping by MALDI-TOF mass spec. Primers with different molecular weights and specific to polymorhphic sites in the template are extended to generate 3’-biotinylated DNA extension products. Since the primer extension products are isolated prior to MS, the resulting spectrum is primer-dimer free.

SHORT READS

Daiichi Pure Chemicals, Toshiba, and Toshiba Hokuto Electronics have unveiled a microarray-based in vitro diagnostic system for human papillomavirus detection and strain typing that the companies have been developing for the past two years.

EiRx Therapeutics and BioMérieux plan to validate the diagnostic and therapeutic potential of their candidate tumor markers for colorectal cancer.

Illumina plans to develop custom SNP content for a multi-sample Sentrix BeadChip for Johnson & Johnson Pharmaceutical Research & Development. Illumina expects to use its Infinium assay to genotype thousands of samples provided by J&J PRD.

Beckman Coulter has acquired an in vitro diagnostic product license to all of Roche’s real-time PCR patents and pending patent applications. In exchange, Beckman Coulter will pay Roche a one-time license fee of $27.5 million and will also pay royalties on sales of all licensed products.

Genizon BioSciences has begun providing SNP genotyping and statistical analysis services using Illumina’s BeadArray instruments, Infinium chips, and GoldenGate marker sets. The company also performs genetic analysis with its own platform, GeneSys.

GlaxoSmithKline will use microarray-based genotyping services from Expression Analysis in its PGx studies for clinical trials.

DATAPOINT

$7.1 million

Amount appropriated by the Arizona Legislature to fund autism research by TGen and the Southwest Autism Research & Resource Center. Ideally, the research will result in an early diagnostic test to identify at-risk children.

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