Fresh from winning the CE Mark as an in vitro diagnostic, Whatman’s multiplex protein chip for autoimmune diseases is ready to launch in Germany, and the company is figuring out the steps it needs to take to begin selling it in the US, Whatman announced last week.
The chip, whose CE Mark came eight months later than had been originally expected, was co-developed with Privates Institut für Immunologie und Molekulargenetik, a German laboratory specializing in autoimmune and other clinical diagnostic assays.
The product can test for 14 different analytes from a single sample while most diagnostics for autoimmune diseases can test for only one analyte at a time, Whatman said.
The company had originally said that CombiChip would be released at the end of 2005, then pushed back the launch date to the first quarter of 2006. In May, Whatman said it had filed CombiChip with European regulators and that the CE Mark could come as early as June.
At last week’s IBC Life Sciences’ Discovery 2 Diagnostics conference in Boston, Brett Stillman, manager of microarray products for Whatman, told ProteoMonitor’s sister publication BioArray News that the delay was due to the company’s decision to move the validation and manufacturing of the chip to IIMG. The chip had been 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 said last week. Stillman said that IIMG 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.”
In an interview with ProteoMonitorthis week, Michael Harvey, director of development for microarrays and molecular biology at Whatman, said the delay was due to “typical things that happen during product launches. Things don’t always happen perfectly on time. … We were making sure that we were doing all the testing we needed to satisfy the regulatory hurdles that are associated with this type of product.”
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 clinicians to determine the specific amount of an antigen in a patient’s serum.
According to Harvey, Whatman 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 said. “We knew that the system worked well for this kind of testing. It’s a current diagnostic need. These people 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.
Harvey added that data from a CombiChip assay is comparable to the data from individual Elisa assays for each of the 14 analytes.
“To get CE marking, we had to run clinical correlations, clinical trials to a certain extent, in which we took a large number of sera, about 300 or so, that had been tested in other formats and compared that to the data we got using the CombiChip,” he said. “In comparison to the tests in which ELISA is the standard, the correlation has been excellent. It’s not 100 percent, but it’s certainly over 90 percent correlation.”
“We’ve only begun … deciding how to get the [product] to the United States and then making sure it complies with whatever FDA wants to see.”
The company’s initial launch will be in Germany where Whatman will be concentrating on the “top-tier laboratories,” said Lisa D’Anzi, director of business development for biosciences at Whatman. The company then will look to launch CombiChip throughout the rest of Europe.
Whatman is currently in the process of meeting with “key” opinion leaders and testing facilities in North America to evaluate whether the current content of the CombiChip is suitable for the North American market or whether Whatman may need to release CombiChip in multiple versions here, D’Anzi said.
“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.
The recent draft guidance from the US Food and Drug Administration for home brew tests [See PM 09/14/06] also will affect Whatman’s strategy for releasing CombiChip here, Harvey said.
“We’ve only begun … deciding how to get the [product] to the United States and then making sure it complies with whatever FDA wants to see,” Harvey said. No target date has been set for a US launch of CombiChip.