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New CombiMatrix Biz to Enter Game as CLIA Shop

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Diving headlong into pharmacogenomics, CombiMatrix has formed a diagnostic subsidiary to begin developing and performing microarray-based tests as a homebrew lab.

“Our real goal is to become the leading molecular diagnostics company in the US,” says Matt Watson, incoming CEO of the new CombiMatrix Molecular Diagnostics unit. “We intend to leverage the CombiMatrix technology to create these [homebrew] tests; that really is our core focus for the company.”

CombiMatrix and CMD think that now is the time to exploit an opening they see in the diagnostics market. Their plan is to temporarily bypass the US Food and Drug Administration’s in vitro device clearance process by making and using microarrays in a new CLIA-approved lab, then performing on-site testing.

It seems that CMD’s expression arrays will compete only against Arcturus Bioscience as it tackles its first disease state — tumors of unknown origin. CMD might have an advantage if it pursues US Labs as a client, according to Watson and Amit Kumar, president and CEO of CombiMatrix. Arcturus has licensed its array data to US Labs in the past, and Watson and incoming CMD chief operating officer Dave Baunoch both left US Labs to head CombiMatrix’s new firm. Watson was vice president of operations and Baunoch was vice president of research and development.

CMD has no interest in taking on the field’s battleaxes — LabCorp, Quest, and other large reference labs — but rather sees them as customers. “Our goal is to obtain our CLIA certification as a laboratory and then to offer these microarray testing services to the larger national laboratories, such as LabCorp, Quest, those types of laboratories,” Watson says. The subsidiary will form partnerships with its parent company, CombiMatrix, but it will produce all its own microarrays and reagents.

— Chris Womack

 

PATENT WATCH

 

US Patent 6,900,016. Polymorphisms in known genes associated with inflammatory autoimmune disease, methods of detection and uses thereof. Inventors: Craig Venter, Jinghui Zhang, Xiangjun Liu, William Rowe, Anibal Cravchik, Francis Kalush, Ashwinikumar Naik, Gangadharan Subramanian, Trevor Woodage. Assignee: Applera. Issued: May 31, 2005.

This invention relates to new SNPs in genes known to contribute to autoimmune and inflammatory disorders, according to the abstract. The patent also covers reagents to detect and express the variant nucleic acid and/or protein sequence to identify the SNPs.

 

US Patent 6,895,337. Method of identifying genomic rearrangements. Inventors: Thomas Scholl, Dmitry Pruss, Brant Hendrickson. Assignee: Myriad Genetics. Issued: May 17, 2005.

This patent covers “methods, computer program products and systems … for detecting large genomic rearrangements based on unphased genotype data obtained using common genotyping techniques that do not differentiate different alleles.”

 

The National Eye Institute at NIH has awarded a $2 million, four-year grant to researchers at North Carolina State University to study the comparative genomics of glaucoma. Scientists plan to search for genes that change during the early stages of glaucoma and then to find polymorphisms in those genes that could predispose carriers to the disease.

 

GE Healthcare announced that it would provide various diagnostic tools to Medicity, a large hospital and research center in New Delhi, India. In addition to the technology installation, GE has agreed to provide utilities such as lighting, water treatment, and power generation and distribution.

 

South Korea will spend $100 million for a genome research project aimed at finding cures for cancer and nine other major diseases, according to the Korean Ministry of Health and Welfare. This will include funding for a project underway at the Korean National Genome Research Institute and the Korea Center for Disease Control and Prevention to establish a SNP database focusing on the Korean population.

 

Stratagene has licensed an 11-gene signature from the Sidney Kimmel Cancer Center for the possible development of a diagnostic that could predict tumor progression and metastasis, theoretically at earlier stages than cancer can be diagnosed today.

 

Datapoint

$39.2 million

Approximate value, in cash, to be paid by Qiagen to acquire Germany’s Artus, a maker of PCR-based diagnostics used for infectious disease detection, pharmacogenomics, and veterinary diagnostics

 

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