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Celera Dx Expected to Sell Alzheimer s Disease ASR to LabCorp This Summer

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Celera Diagnostics this summer will likely begin selling an analyte-specific reagent for Alzheimer’s disease to a large reference laboratory, according to an industry analyst.

Anticipation of the product, which will be the fourth ASR product commercialized by Celera Diagnostics, has been stirring chatter in molecular diagnostics and pharmacogenomics circles in recent months as the company’s partnership with Abbott Labs continues to grow.

Ted Tenthoff, an analyst for Piper Jaffray who covers Applera, Celera Diagnostics’ parent company, said the level of data accumulated by the company and its undisclosed academic collaborators has led him to believe that the next ASR to be marketed to large reference labs will be for Alzheimer’s disease. He added that he believes it will be sold to LabCorp. Celera Diagnostics and LabCorp already have a partnership in Alzheimer’s disease.

Tenthoff made his remarks during a breakout session at the Piper Jaffray life sciences conference in New York City last week that featured a presentation by Applied Biosystems investor relations director Linda Greub. Though Greub declined to comment about the application of the ASR that she had indicated will roll out this summer, she nodded when Tenthoff said it will be for Alzheimer’s disease.

Celera Diagnostics spokeswoman Karen White declined to comment on the application of the upcoming ASR, but confirmed it is due in the summer. She also declined to say whether LabCorp will market the product.

Celera Diagnostic currently sells a trio of ASRs: one for cystic fibrosis, which detects mutations in the CFTR gene; one that identifies mutations in the hepatitis C virus; and one that quantifies the presence of HCV in individual patients.

The company has been saying since last August that it has been conducting nine association studies — in arthritis, breast cancer metastasis, Alzheimer’s, interferon responsiveness, an undisclosed metabolic disease, and a quartet of cardiovascular diseases — that it hopes will eventually lead to molecular diagnostic products.

The ASR route will also likely play a substantial role in Celera Diagnostics’ ongoing objective of developing additional in vitro diagnostics products, such as its ViroSeq genotyping system for HIV-1. For example, the company may choose to file any of the three existing ASRs for IVD status, said White.

Until now, there has been broad speculation into the likely indication of Celera’s next ASR. Beside Alzheimer’s disease, some leading contenders include breast cancer and HCV drug response. Specifically, in early November, Celera Diagnostics showed at the International Association for Breast Cancer Research certain gene-expression markers the company said are associated with an increased risk of distant metastasis in women with breast cancer.

The company’s results “suggest a constellation of markers monitoring expression of 10 or fewer genes is likely to be highly predictive of risk for metastasis in breast cancer,” Celera Diagnostics president Kathy Ordoñez said during the company’s conference call on Jan. 28. “Such a constellation could be used in conjunction with other current criteria such as tumor size and grade, age, estrogen receptor status, and lymph node involvement to make treatment decisions.

“If analysis of additional tumor collections confirms these findings,” Ordoñez went on, “we would begin development of a prototype product.” She added that a collaboration with Rosetta Inpharmatics and its parent company Merck, which Celera Diagnostics announced in October “provides us with access to certain gene expression data and intellectual property that should accelerate our efforts to develop a prognostic test for metastasis in breast cancer [see 10/23/03 SNPtech Pharmacogenomics Reporter].

In addition, at a hepatitis conference in Japan two months ago, Celera Diagnostics suggested it may be possible to use mRNA patterns to identify patients unlikely to respond to the drug.

And it was at the American Society of Human Genetics meeting in Los Angeles in November that the company showed that a pair of haplotypes in the insulin-degrading enzyme gene might protect against the increased risk of Alzheimer’s disease conferred by the ApoE4 mutation.

In her conference call remarks, Ordoñez said Celera Diagnostics plans in the spring to release findings from two studies looking at interferon response in HCV, and the risk of myocardial infarction.

Tony White, CEO of Applera, added in the call: “We expect additional scientific presentations in the coming months.”

He said the company “is moving toward incorporation of the markers into prototype diagnostic products, while Celera Genomics is evaluating the therapeutic utility of selected markers.” Celera Diagnostics is a 50-50 joint venture between Applied Biosystems and Celera Genomics.

Celera Diagnostics’ ASR foray picked up speed when the firm penned a long-term collaboration with Abbott Labs in June 2002. For this partnership, the companies have not only shared technologies and leads, but have also been tied at the hip financially. For instance, Celera Diagnostics’ nine association studies — and the three existing ASRs that resulted from them — were developed from the R&D budget that Celera provides to the alliance, according to Celera Diagnostics CSO Tom White. To that end, for example, Celera Diagnostics is obliged to sell to Abbott Labs diagnostics products at cost, while Abbott would sell the products to a wide range of labs — it has many relationships — at a marked-up price. Both firms would split profits.

The strategy appears to be working for Celera Diagnostics: Two weeks ago the company said that fiscal second-quarter revenues increased to $11 million from $7.8 million for the same period a year ago. Additionally, net loss for the quarter narrowed to $9.3 million from $9.9 million year over year.

Fiscal second-quarter end-user product sales of products manufactured by Celera Diagnostics — which are marketed primarily by Abbott Labs — doubled to $10 million from $5 million one year ago, the company said. Celera Diagnostics attributed the increase to strong growth in sales of its cystic fibrosis ASRs and, to a lesser extent, of products for infectious disease testing.

— KL

 

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