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Roche Looks to Lead in Emerging Theranostics Space


Roche Diagnostics is taking advantage of the US Food and Drug Administration’s nascent drug-diagnostic co-development “concept paper” by moving a companion diagnostic-therapeutic cancer product through its pipeline, the Swiss company said in April.

The diagnostics giant will “absolutely” develop its P53 AmpliChip resequencing assay, which runs on Affymetrix’s GeneChip reader, together with a cancer drug known tentatively as Nutlin, says Jim Gallarda, director of marketing development of clinical genomics at Roche. Gallarda’s group is largely responsible for AmpliChip’s entry into the market.

The co-development, if successful, will result in a cancer drug accompanied by a test capable of identifying patients with solid tumors for which the drug likely will not work. Roche would not disclose the specific indication for which it would apply the chip or its therapeutic mate. With Nutlin and P53, Roche is taking an early lead in the co-development process, following up on its success with AmpliChip P450, which became the first microarray product to achieve FDA clearance for use as an in vitro device.

Roche is already using the test to stratify patients during clinical trials of Nutlin, and it is planning on partnerships with others in pharma. However, Roche plans to investigate whether the chip can be useful for cancer patient prognosis or in identifying patients who may respond to other particular classes of drugs, Gallarda says.

Roche has not yet filed the AmpliChip P53 for clearance with the FDA, and the company has not decided whether it would take the 510(k) or premarket clearance route, Gallarda says. It is faster to achieve 510(k) clearance, while a PMA “allows you to make more specific claims about the intended use of the test,” he adds. The AmpliChip P53 will not be released prior to FDA clearance, he says.

— Chris Womack




US Patent 6,884,583. Determination of a genotype of an amplification product at multiple allelic sites. Inventors: Kenneth Livak, Frederico Goodsaid. Assignee: Applera. Issued: April 26, 2005.

According to the abstract, this patent covers a method “for genotyping a target sequence at at least two allelic sites by a 5’ nuclease amplification reaction. … The method includes performing a nucleic acid amplification on a target sequence having at least two different allelic sites using a nucleic acid polymerase having 5’’3’ nuclease activity and a primer capable of hybridizing to the target sequence in the presence of two or more sets of [certain] allelic oligonucleotide probes.”


US Patent 6,878,530. Methods for detecting polymorphisms in nucleic acids. Inventor: Qinghong Yang. Assignee: Panomics. Issued: April 12, 2005.

This invention deals with “determining the genotype of a nucleic acid at the site of a polymorphism,” according to the abstract. “The methods achieve sensitivities great enough to detect the presence of any difference between the nucleic acids, even single nucleotide polymorphisms.”




Program announcement number for new NIH initiative to validate biomarkers for human diseases implicated in liver, kidney, urological tract, digestive, and hematologic systems; endocrine and metabolic disorders; and diabetes and obesity. Nonprofit and for-profit organizations are eligible for funding. NIH plans to fund up to 10 grants for the program, and applications are due September 1.


Gentris closed a funding round worth $5 million with Mitsui USA that will help it develop and distribute pharma-cogenomic diagnostic testing kits.


Researchers at the University of Southern California and Baylor College of Medicine will use ParAllele’s SNP genotyping panel for association studies on lupus and respiratory pathogens.


General Electric’s Global Research and GE Healthcare divisions will work together with Eli Lilly on a research collaboration to find and design diagnostics and therapeutics for Alzheimer’s disease.


The Alaska Department of Fish and Game has expanded a salmon genotyping project aimed at tracking migration patterns and intermixing of populations of wild Pacific salmon. Selected SNPs will be added to a standardized marker database to be used by Pacific coastal nations including the US, Russia, Korea, and Japan. Researchers will use technology from Applied Biosystems for the project.


CombiMatrix has launched a molecular diagnostics subsidiary that will focus on microarray-based diagnostics. CombiMatrix Molecular Diagnostics will serve as a testing center for clinicians and will begin development in the area of cancer diagnostics.


Quest Diagnostics agreed to make a $15 million equity investment in SomaLogic, in return for which Quest will develop new diagnostic tests based on SomaLogic’s aptamer array platform.


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