Celera Diagnostics will deliver its first internally developed genetic test to a large reference lab in July, according to a company official.
The announcement by company president Kathy Ordoñez, made at the BIO CEO conference in New York City this week, means that the Applera unit may be able to market the assay as an FDA-approved in vitro diagnostic as early as January 2005.
Ordoñez stressed that regulatory quirks at the agency may delay the launch by around three months, and said Celera Diagnostics is currently discussing regulatory options for the new assay with the FDA. She would not say whether the product would be filed as a PMA or a 510(k).
The new assay, which represents the first fruit of Celera Diagnostics’ internal disease-association study program, will initially be marketed as an analyte-specific reagent to a large reference lab, such as LabCorp or Quest Diagnostics, Celera Diagnostics has previously said.
The Applera unit currently sells a trio of ASRs, but these were not derived from the nine association trials currently underway at the company. Consequently, the assay promised for July is an important milestone for Celera Diagnostics and its deal with distribution partner Abbott Labs. In addition, because Celera Diagnostics has previously said it intends to transfer the assay to a reference lab sometime during the summer, Ordoñez’ disclosure is welcome color to customers, investors, and rivals.
Ordoñez, a former president of Roche Diagnostics, would not specify the disease that the new ASR will cover, or name the reference lab to which it will be transferred. However, SNPtech Pharmacogenomics Reporter said recently that a prominent analyst predicts the product will likely be for Alzheimer’s disease, and the reference lab will probably be LabCorp [see 2/5/04 SNPtech Pharmacogenomics Reporter].
Currently underway at Celera Diagnostics are nine disease-association studies covering arthritis, breast cancer metastasis, Alzheimer’s disease, interferon response in hepatitis C, an undisclosed metabolic disease, and certain cardiovascular diseases, including myocardial infarction. Results of four of these studies — those on MI, Alzheimer’s disease, interferon response, and breast cancer — have already been published.
Speaking at the BIO CEO conference, Ordoñez said Celera Diagnostics expects to publish data from certain other of these studies between March and July. Additionally, Celera Genomics, which controls Celera Diagnostics in a 50-50 joint venture with Applied Biosystems, is currently evaluating the therapeutic utility of two of the nine biomarkers under study at Celera Diagnostics, Ordoñez said.
Researchers working on the disease-association studies have access to almost 43,500 genes found in the recently completed Applera Genomics Initiative, as well as access to more than 45,000 clinical samples, Ordoñez said [see 3/23/03 SNPtech Pharmacogenomics Reporter]. She added that the company expects to break even in fiscal 2006, and that the products of the disease-association studies, together with continued interest in its existing ASR products, will drive top-line growth.
However, Ordoñez stressed that it is notoriously risky to rely on disease-association studies as a way to develop marketable assays, not to mention profitable IVD products. Generally, less than 2 percent of all associations reported industry-wide were “ever able” to make it to market, she said.
Anticipation of the new ASR has been a source of interest in molecular diagnostics and pharmacogenomics circles in recent months, as the company’s partnership with Abbott Labs continues to grow [see 8/21/03 SNPtech Pharmacogenomics Reporter].
Ted Tenthoff, an analyst at Piper Jaffray who covers Applera, released some of the pressure recently when he said the July ASR 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 earlier this month that featured a presentation by ABI investor relations director Linda Greub. Though Greub declined to comment about the application of the ASR that she’d 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, and said, following the publication of an earlier SNPtech Pharmacogenomics Reporter, that Greub’s nod ought not be construed as a confirmation of Tenthoff’s speculation . White also declined to say whether LabCorp will market the product.
The three ASRs Celera Diagnostics currently sells include 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 ASR route will likely play a significant role in the company’s goal of developing additional in vitro diagnostics products, such as its ViroSeq genotyping system for HIV-1. Celera Diagnostics can file any of its ASRs for IVD status, White had said.
Until now, there has been broad speculation into the likely indication of Celera’s next ASR. Besides Alzheimer’s disease, other 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 study 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,” Ordoñez said during Celera Diagnostics’ fiscal second-quarter conference call Jan. 28. “Such a constellation could be used ... 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, “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, a speaker from Celera Diagnostics suggested it may be possible to use mRNA patterns to identify patients unlikely to respond to interferon.
And it was at the November meeting of the American Society of Human Genetics in Los Angeles that the firm showed that two haplotypes in the insulin-degrading enzyme gene may protect against an increased risk of Alzheimer’s disease conferred by the ApoE4 SNP.
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.