Celera Diagnostics next month will complete four of approximately six disease-association studies whose results, if validated, will become part of a suite of new multi-analyte-based diagnostic products, a Celera spokesman said last week.
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 Laboratories last year. Celera Diagnostics 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, according to CSO Tom White.
But Celera Diagnostics must first wend through a series of internal validation procedures while maintaining a delicate balance until the US Food and Drug Administration formalizes a draft guidance that has been circulating IVD circles since the end of April [see SNPtech Reporter, May 24, 2003].
“Our intention is to discover and confirm markers, develop them into ASRs, and to enter into design and control (studies) to take it through the FDA registration process,” White told SNPtech Reporter. “Our real objective is to make FDA-regulated in vitro diagnostics products.” He said the ASRs the company is currently developing represent “one step on the way” to FDA-approved tests.
Generally, the association studies Celera Diagnostics conducts “come within the R&D budget that Celera Diagnostics provides to the alliance with Abbott,” White told SNPtech Reporter. (He is not related to Tony White, CEO of Applera, Celera Diagnostics’ parent company.) The “budget,” in this case, refers to expenditures as well as profit.
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 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 third-quarter revenue surged to $4.3 million from $2.7 million in the same period one year ago (the company’s fiscal year runs from July 1 to June 30.) The firm also said it expects to report between $18 million and $22 million in receipts for fiscal 2003.
High-throughput Version of Viroseq in the Works
SNPtech Reporter also learned that Celera Diagnostics currently is testing a third iteration of its recently approved HIV-1 diagnostic product ViroSeq — this latest one for ultrahigh-throughput molecular-diagnostics labs — which also is tied into the Abbott alliance.
This development took root in February when the FDA, having approved the use of the ViroSeq with the 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. While the Applera offspring designed the test in-house, Abbott Labs, in a deal penned last June, will use its considerable marketing and distribution muscle to sell it worldwide.
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. Abbott, the second-largest in vitro diagnostics shop in the world, has also been marketing and distributing the 377-fitted ViroSeq.
According to White, Celera Diagnostics is currently testing the application of ABI’s 3700 and 3730 capillary sequencers to the ViroSeq product. He wouldn’t comment on the status of this research, which is a requisite for FDA approval, but said that Celera ultimately hopes to launch an ultrahigh-throughput iteration of the diagnostic that can be used by powerhouse labs like LabCorp and Quest Diagnostics.
PCR-Based SARS Test in Development
Abbott will also leverage its deal with Celera Diagnostics to market and distribute a PCR-based SARS test developed by German biotech company Artus. Terms of this deal, penned in mid-May, call for Artus to manufacture the test and for Abbott to market and distribute it initially for use on the Roche LightCycler thermal cycler system in North America, the UK, Germany, and Austria. The test, believed to be the first commercial PCR-based diagnostic of its kind, will soon be available worldwide on the Applied Biosystems ABI Prism 7000 Sequence Detection System.
“Our collaboration with Abbott is expected to speed the successful commercialization of new molecular diagnostic products,” Celera Diagnostics President Kathy Ordoñez said last year. She also said that the collaboration “reduces the risk” of Celera Diagnostics not reaching profitability by the end of 2005 or 2006.