BOSTON — Whatman this week said that its CombiChip multiplex protein biochip has received CE registration as an in vitro diagnostic and will be available to reference labs as a CE-marked IVD kit.
The product, indicated for autoimmune diseases, won the agency’s approval around three months later than its most recent prediction, and around eight months later than it had originally expected it to become approved.
In August 2005, Whatman said it would launch the CombiChip as an IVD by the end of that year, but in January officials pushed back that date to the first quarter of 2006. In May Whatman filed the CombiChip with European regulators and said at the time that it expected to win the CE Mark as early as June (see BAN 1/17/2006, BAN 6/20/2006).
According to Brett Stillman, the company's manager of microarray products, one of the main factors causing the delay in the launch of the CombiChip was an internal decision to transfer the manufacturing and validation of the chip to the Privates Institut fur Immunologie und Molekulargenetik, a Karlsrühe, Germany-based reference laboratory. The chip was originally developed at Whatman’s R&D facility in Sanford, Maine.
“We had to get IIMG set up to manufacture arrays to our quality,” Stillman told BioArray News at IBC Life Sciences’ Discovery 2 Diagnostics conference, held here this week.
“It’s going to be a diagnostic in Europe and the decision was made to make it in Europe and sell it in Europe,” he explained.
Stillman said that IIM had manufactured and validated other assays that had been CE Marked in the past, so Whatman chose to work with a “site that had all of the CE experience of making and validating assays.”
According to Whatman, the CombiChip requires a single, low-volume serum sample to generate results for 14 different antigens associated with a number of autoimmune diseases. It also reduces analysis time to two or three hours, Whatman said.
The array itself 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, including systemic and neonatal lupus, Sjögren's syndrome, systemic sclerosis, and rheumatoid arthritis. The IgG calibrator enables the clinician to determine the specific amount of an antigen in a patient’s serum.
According to Michael Harvey, Whatman’s principal scientist, the company decided to target autoimmune diseases because of the clinical need for such a multiplex assay.
“The kinds of systems that lend themselves to multiplexing in diagnostics have a tendency to be serological assays,” Harvey told BioArray News here this week.
“We knew that the system worked well for this kind of testing. It’s a current diagnostic need. These people’s do these assays now. It’s a little different from a DNA array situation where you are trying to convince people that indication that you see is indeed important to management of the disease. What we are doing is adding the convenience factor to a set of tests that people already do,” he said.
German Outreach, US Strategy
Lisa D'Anzi, director of business development in Whatman's biosciences unit, told BioArray News herethis week that Whatman’s initial commercial efforts for the CombiChip will be in Germany, making use of its partners at IIMG as well as its existing Whatman personnel. Whatman acquired German slide manufacturer Schleicher and Schuell Bioscience in 2004 (see BAN 8/10/2004).
“Initially we’ll be launching in Germany. We will be working through a sales infrastructure in Germany made up of Whatman personnel and Schleicher and Schuell and we will target all of the top diagnostic laboratories,” she said.
“It’s a little different from a DNA array situation, where you are trying to convince people that indication that you see is indeed important to management of the disease. What we are doing is adding the convenience factor to a set of tests that people already do.”
Andrea Frisse, Whatman’s product manager for protein arrays Europe, said that Whatman will offer European wet-lab demos as well as free workshops. The company will also help users find instrumentation for running the assays. Whatman has no agreements with scanner manufacturers, although it recommends using Molecular Devices’ GenePix scanner.
“Whatman is not an instrument manufacturer. We have set some specific instrument providers as suitable to measure a CombiChip, but every single scanner system is suitable to measure the slides,” she told BioArray News this week.
In terms of reaching the US market, D’Anzi said that Whatman is working with immunologists to determine whether the current content of the CombiChip is suitable for the North American market. Once the content is determined, Whatman will initiate a US launch.
“Basically, when you look at the content we currently have, it was developed through IIMG. You can make the assumption that throughout North America that’s the only content that would be pertinent to CROs or diagnostic testing facilities. That would be a mistake,” she said.
“We will be working with individuals in the field of immunology to make sure that if we need to update the content on the panel, or have special versions of the CombiChip. We will do so before having it launch in North America,” she said.
D’Anzi declined to discuss pricing for the CombiChip.