Overcoming a five-month delay, Whatman has filed its Combichip product with European regulators and expects the protein-based diagnostic array, indicated for autoimmune diseases, to win the CE Mark as early as next month, officials told BioArray News this week.
The officials, which have not disclosed specific plans for launching the chip in the US, also said the company intends to launch an automated, high-throughput format of its flagship array slides in the second half of this year.
Whatman has the Combichip "almost ready to go," Brett Stillman, the company's manager of microarray products, told BioArray News this week. "The paperwork for the CE filing in Europe has been completed and it's been registered with the authorities in Europe. So on the regulatory side it has proceeded nicely."
Whatman in August 2005 said it would launch the Combichip by the end of that year. In January, officials pushed back the release to the first quarter of 2006. Now, the company said that the second content array it has ever produced will make its market debut as an in vitro diagnostic between four and eight weeks (see BAN 8/10/2005, BAN 1/10/2006).
For the most part, Whatman is known as a microarray slide provider. The company has recently been turning its focus towards content, and launched its first content-specific array two years ago. The array, called the Serum Biomarker Chip, was a legacy from its 2004 acquisition of German slide firm Schleicher & Schuell (see BAN 11/10/2004).
"Right now, we are really working in getting the Combichip CE Marked. Once we have that done and we create the right partnerships and relationships in Europe, we will look to work with pharmas and clinical research organizations within the US."
Stillman acknowledged that the Combichip release was "delayed overall" and attributed the tardiness to additional beta-site testing and to a new software package that will be launched with Combichip.
"We are finishing a software package that comes along with the product," Stillman said. "That is one of the main reasons [for the delay]."
The software, called SpotQuant, has been developed with Boston-based ViGene Tech. According to Stillman, SpotQuant will eventually be "suitable for analyzing virtually all protein array configurations" and will replace its current offering for protein array products.
The Combichip, which is also Whatman's first foray into the array-based diagnostics space, can measure from a single serum sample the presence of 14 autoantibodies associated with around 10 different collagenosis and vasculitis-related autoimmune diseases, according to the company.
During a presentation at PepTalk in San Diego in January, Michael Harvey, Whatman's principal scientist, said the CombiChip targets systemic and neonatal lupus, Sjögren's syndrome, systemic sclerosis, and rheumatoid arthritis.
He also presented data at the conference 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 (see BAN 1/17/2006).
Still No Timeline for US Launch
At PepTalk, Harvey said UK-based Whatman will launch Combichip first in Europe and then in the US once it wins US Food and Drug Administration clearance. However, Harvey did not provide a timeline for a US launch, and Whatman this week said again that it has no definitive schedule for making the Combichip available to clinicians in the US. It also would not say when it plans to file the chip with US regulators.
"Right now, we are really working on getting the Combichip CE Marked," Lisa D'Anzi, director of business development in Whatman's biosciences unit, told BioArray News this week. "Once we have that done and we create the right partnerships and relationships in Europe, we will look to work with pharmas and clinical research organizations within the US."
"[We are] doing a marketing assessment on how the US market will adopt this and if the elements are sufficient enough for the US users to adopt the Combichip,"she said. D'Anzi noted that other array-based diagnostics, such as Roche's AmpliChip, had followed a similar path of getting a CE Mark before receiving US FDA 510(k) clearance. Like the Combichip, the AmpliChip was also late to market.
96-Well Plate Format
A separate development in Whatman's array business is the planned launch of its 96-well plate format for its flagship FAST slides. As the company revealed in its annual report in April, it plans to launch the 96-well plates in the second half of this year.
D'Anzi said the company developed the new format to target biotech and pharmaceutical companies, which "will need to have an automation-friendly, high-throughput format," she said. The highest throughput Whatman currently offers is its 16-well plate format, which for its academic customers "is more than sufficient," D'Anzi added.
Stillman, the microarray products manager, said that the new format will work with "any array platform that can handle a 96-well footprint."
"There are a couple scanners that can accommodate a plate of that size," he said, including the Tecan LS. For processing stamps, Stillman said that any liquid handler that can "pick up and maneuver around 96-well plates" will be able to handle the 96-well format because the company is building to standards for microplates as set by the Society for Biomolecular Screening.
Once Whatman enters that arena though, it will not be alone. The company will face stiff competition in the 96-well format from rival slide companies like GenTel BioSciences, Schott-Nexterion, Beckman Coulter, and Corning Life Sciences.
— Justin Petrone ([email protected])