Celera Diagnostics currently has nine disease-association studies underway — three more than it had as of late May — and will publish three of these in the fall, the company said earlier this week.
“Our intention is to discover and confirm markers, develop them into ASRs, and to enter into design and control (studies) to take them through the FDA registration process,” Celera Diagnostics CSO Tom White told SNPtech Reporter in May, when the company announced the first six studies. “Our real objective is to make FDA-regulated in vitro diagnostics products.”
The disease areas, which include Alzheimer’s disease, cardiovascular disease, rheumatoid arthritis, and breast cancer, represent the cornerstone of an R&D alliance the Applera unit forged with Abbott Labs last year. Celera hopes the long-term deal, which ties together research efforts from the University of California at San Francisco, Hyseq, Bristol-Myers Squibb, and Genomics Collaborative, will cement its place in the $1 billion in vitro diagnostics marketplace, White said.
Celera Diagnostics President Kathy Ordoñez, speaking to investors during the firm’s fourth-quarter conference call last month, said the company has obtained more than 30,000 patient samples, and has completed more than 40 million genotypes. “Most importantly,” she said, “we are beginning to make and replicate discoveries.”
For example, in four of the nine association studies, Celera Diagnostics has identified new associations between an undisclosed disease and SNPs in multiple genes. The company and its Celera Genomics sibling are currently evaluating the “diagnostic and therapeutic value” of these markers and potential targets, and are “discussing the findings with collaborators and preparing patent submissions and product plans,” Ordoñez said [see transcript of Ordoñez’ speech, page 6].
In broad terms, the association studies fall within the R&D budget that Celera Diagnostics provides to the alliance with Abbott, White said. For example, according to Celera Genomics spokesman Rob Bennett, one component of the Celera Diagnostics-Abbott Labs agreement calls for the former to sell the latter’s diagnostics products at cost. Abbott would then sell the products to a wide range of labs at a marked=up price, and both companies would split the profits.
The strategy appears to be working for Celera Diagnostics: Fiscal fourth-quarter revenue swelled to $5.6 million from $2.8 million in the year-ago period, and total revenues for fiscal year 2003, which ended June 30, more than doubled to $20.8 million from $9.2 million reported for fiscal 2002, Celera said.
The company said receipts from product sales alone grew to $8.7 million in the fourth quarter from $3.6 million in the same quarter one year ago. The firm attributed the growth to strong sales of its cystic fibrosis analyte specific reagents and, “to a lesser extent,” to the ViroSeq HIV-1 genotyping system. ViroSeq uses DNA sequencing technology to identify strains of the HIV-1 virus, targeting regions of the viral genome associated with drug-resistant mutations. Some 150,000 HIV genotyping tests are conducted each year, Celera said.
In June, the US Food and Drug Administration approved Celera Diagnostics to market the ViroSeq platform with the ABI PRISM 3700 gene sequencer, which Celera said it intends to market to large reference labs like LabCorp and Quest Diagnostics. Celera Diagnostics spokeswoman Kathy White (no relation to Tom White, or Tony White, Applera’s CEO) said the company currently has customers for the product in this iteration, but declined to say who they are. Abbott, the second-largest in vitro diagnostics shop in the world, markets the three ViroSeq iterations.
The June approval took root in February when the FDA, having approved the use of the ViroSeq with ABI’s PRISM 3100 gene analyzer, gave Celera Diagnostics the green light to begin marketing the ViroSeq product to regional medium- and high-throughput labs like the Mayo Clinic and ARUP Biosciences. The 510(k) approval came two months after the FDA allowed the ViroSeq product to be used with ABI’s PRISM 377 sequencer. (A 510[k] is a relatively easy application process for a product that is equivalent to an existing product, and that is not a critical device.) This initial marketing clearance, which represented the first fruit of the Celera/Abbott partnership, made it possible for Celera to sell the diagnostic to low-throughput labs like university hospitals.