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Celera Licenses Decode Gene Markers to Grow Cardiovascular Dx Franchise

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Decode announced last week that it had granted Celera non-exclusive worldwide rights to genetic markers for various cardiovascular and metabolic diseases.

The deal will give cash-strapped Decode immediate access to an undisclosed sum in upfront payments, while Celera will gain access to gene markers that will complement and expand its cardiovascular disease-focused genetic testing service.

Under the terms of the agreement, Decode will receive an upfront payment and royalties on sales of testing products incorporating its markers. Although additional financial details of the deal were not disclosed, Decode Chief Scientific Officer Jeffrey Gulcher said that the upfront payment will post this quarter, which may help with the company's dwindling cash position.

As of Dec. 31, 2008, the Reykjavik, Iceland-based diagnostic and drug developer held cash, cash equivalents, and current investments of $3.7 million — enough to continue operations until the end of June. Company officials said earlier this month that the firm was "engaged in negotiations" for several alternatives to bring in additional cash [see PGx Reporter 04-01-2009].

Gulcher told Pharmacogenomics Reporter last week that licensing deals similar to the one with Celera might be a promising strategic option for the company in the near term. "We have too much content to market ourselves," Gulcher noted. "There has been much interest from other companies in licensing our markers and we are evaluating potential opportunities with companies that have the right capabilities."

Among the markers licensed to Celera are SNPs on chromosome 9p21 linked to increased risk of heart attack and aortic aneurysm; SNPs on chromosome 4q25 conferring risk of atrial fibrillation and stroke; and SNPs in the TCF7L2 gene linked to increased risk of type-2 diabetes.

Decode currently markets six genetic tests for glaucoma, atrial fibrillation, myocardial infarction, type 2 diabetes, prostate cancer, and breast cancer. All the SNPs licensed to Celera are currently used by Decode in its own product offerings. For instance, its type 2 diabetes test, Decode T2, is based on a SNP in the TCF7L2 gene; Decode AF detects versions of two common SNPs on chromosome 4q25; and Decode MI detects SNPs in the 9p21 chromosome.

Celera is planning to incorporate the licensed SNPs in the cardiovascular genetic testing service it offers to physicians through its CLIA-certified Berkeley HeartLab. The cardiovascular and metabolic disease markers licensed from Decode complement the Celera-discovered KIF6 marker, which was associated with up to 55 percent increased risk for coronary heart disease in five prospective studies totaling 60,000 participants.

"KIF6 is the most advanced marker in our service offerings," David Speechly, Celera's VP of corporate affairs, told Pharmacogenomics Reporter last week. Celera's current focus is "strongly cardiovascular," he said, with markers for statin benefit, aspirin benefit, deep vein thrombosis, stroke, pulmonary embolism, and early myocardial infarction.

Celera is currently in discussions with the US Food and Drug Administration about registering a KIF-6 test kit [see PGx Reporter 11-08-2008].

The company's test kits are based on the m2000 RealTime PCR System and are distributed by Abbott.

The markers licensed from Decode are highly replicated and show good risk profiles, according to Speechly.

According to a study conducted by Decode researchers and published in 2007, individuals who carry two copies of the at-risk SNPs on chromosome 9p21 are at an approximately 60 percent greater than average risk of early-onset heart attack. "Physicians could use this information and expert opinion to optimize the appropriate lifestyle, dietary and drug treatments for their patients," Decode said in a statement.

Carrying two copies of the SNPs on 4q25 correlates to both an increased risk of stroke and up to twice the average risk of atrial fibrillation, according to a study published by researchers from Decode and others in 2007. "Testing for this risk factor provides a new means of identifying stroke patients who could most benefit from outpatient cardiac monitoring," Decode said in a statement.

SNPs in TCF7L2 were also significantly associated with risk of type 2 diabetes in a study published in 2006 by Decode researchers and others.

According to Celera's Speechly, the company will decide on a case-by-case basis which of the licensed markers to develop into FDA-cleared tests.

"We would take each one on a case-by-case basis, but it is the intention that if we see that these SNPs have the clinical utility that we think they will, we will offer them as a service and then we'd look to offer them as a registered test," he said.

Celera currently markets a cystic fibrosis genotyping assay, and has discovered genetic markers for thrombophilia, fragile X syndrome, lung cancer, breast cancer, and liver fibrosis. Last week, at the American Association of Cancer Research's annual meeting in Denver, Colo., the company announced it was expediting development of a breast cancer test based on promising clinical trial results [see PGx Reporter 04-22-2009].

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