SAN DIEGO — Whatman, a UK-owned array company known for its microarray slide technology, will launch a protein-based diagnostic chip for autoimmune diseases this quarter, according to a company official.
Michael Harvey, Whatman's principal scientist, said that his company will begin selling the array, called CombiChip, to reference laboratories in Europe this quarter, marking Whatman's first foray into the diagnostic space. Harvey made his comments at Cambridge Healthtech Institute's annual PepTalk conference, held here last week.
"Validation studies are being completed comparing antibody results from clinical samples using this array," Harvey told PepTalk attendees. He said that Whatman is seeking to obtain CE Mark approval for the CombiChip this quarter and that the "clinical version of the array analysis software" for the array, co-developed with VigeneTech, will be available next month.
The content on the array, which is printed on Whatman's nitrocellulose-coated FAST array slides, was developed through an agreement with Privates Institut f r Immunologie und Molekulargenetik, or IIMG, a German reference laboratory. The duo announced their work on the project last August (see BAN 8/10/2005).
"[Users] can take a single sample and get 14 answers versus having to run 14 different tests in the laboratory."
Harvey said that the array developed with IIMG consists of 14 autoantigens as well as double stranded DNA and an IgG concentration calibrator. CombiChip can measure the presence of autoantibodies associated with around 10 different collagenosis and vasculitis-related autoimmune diseases from a single serum sample, he said.
Diseases targeted by CombiChip include systemic and neonatal lupus, Sjögren's syndrome, systemic sclerosis, and rheumatoid arthritis, Harvey said. He presented data showing that data from a CombiChip assay was comparable across the board to individual ELISA assays for each of the 14 analytes. Harvey argued that by making these 14 analytes available in one assay, Whatman could save clinicians time and money.
"[Users] can take a single sample and get 14 answers versus having to run 14 different tests in the laboratory," Harvey said.
Europe Today, America Tomorrow
Harvey said Whatman plans to file the CombiChip with the US Food and Drug Administration for 510(k) clearance at a later date. In order to clear US regulatory hurdles, Harvey said Whatman "may seek to partner [with another company] or may launch the chip earlier for research-use-only" in the North American marketplace.
While the FDA's comparatively more stringent requirements likely helped convince Whatman to play in Europe first, Brett Stillman, the company's manager of microarray products, told BioArray News this week that the decision was made for other reasons.
"510(k), I believe, is more difficult [than obtaining a CE Mark], but we have a strong presence in Europe. Schleicher & Schuell is a German company and Whatman is British," Stillman said. Whatman acquired S&S last year for $65 million (see BAN 8/10/2004).
Stillman added that the company's primary collaborator, IIMG, is the largest reference testing lab in Germany. "It really is a better market for us to start out," he said. He added that the company expects it could receive its CE Mark in February or March, and that Whatman needs that approval before it launches the product.
Stillman said that the CombiChip was significant not only because of its content but because of its diagnostic applications — a first for Whatman. The company also launched its Serum Biomarker Chip a year and a half ago for biomarker discovery in oncology. The Serum Biomarker Chip enables researchers to profile 120 cancer biomarker proteins simultaneously, according to Stillman.
"We have a lot of other products, mainly for research use only," Stillman said, "[but] this is our first foray into diagnostics. Certainly I think it's everybody's goal to get arrays into the diagnostic area because they save lots of time and money."
If it does file the test in the US and win clearance, Whatman will face rivals. Among them is BioArray Solutions, which last June was cleared by the FDA for an assay on its microarray platform that profiles six antibodies associated with autoimmune diseases and connective tissue disorders. Like Whatman's CombiChip, BioArray Solution's Extractable Nuclear Antigen assay includes biomarkers for systemic lupus erythematoseus, mixed connective tissue disease, Sjögren's syndrome, scleroderma, and myotisis (see BAN 6/22/2005).
A New Trend?
Whatman's recent move to enter the diagnostics space, and the market for content arrays in general, was driven by market demand, according to Stillman. And it appears that Whatman isn't the only protein array company looking to expand its content array portfolio.
Alla Zilberman, EMD Biosciences' senior technical liason, told BioArray News at PepTalk last week that EMD is planning to add an angiogenesis array to its ProteoPlex array portfolio by the end of the month. EMD has been selling human and mouse cytokine arrays since it acquired the 16-well multi-cytokine protein array from St. Louis-based ProtoPlex in 2003 (see BAN 8/10/2003).
Zilberman said that EMD was looking to replace ELISA tests for angiogenesis markers with a multiplexed assay on an array platform.
"What we are trying to achieve with this technology is the same degree of reliability that ELISA has," she said. Zilberman added that the array was intended for researchers studying cancer and cardiovascular diseases.
"Angiogenesis is a growing field. When you study angiogenesis you want to study a few major targets related to angiogenesis. It makes sense to process samples from a few analytes and this is what this array allows us to do," she said.
Another protein array firm eyeing portfolio expansion is Clontech. Sejal Desai, product manager at Clontech, told BioArray News at PepTalk last week that the company has plans to add arrays for cytokines and phosphotyrosine profiling in the future.
The company, a subsidiary of Takara Bio, has been selling its Ab Array 500, which Clontech claims enables users to fluorescently detect proteins for signal transduction, cell-cycle regulation, gene transcription, and apoptosis, for nearly three years (see BAN 4/11/2003).
Desai declined to give exact dates for when the new chips may launch.
— Justin Petrone ([email protected])