Despite recent declarations from both LabCorp and Quest Diagnostics that each was validating Roche's CYP450 AmpliChip as a prelude to offering testing services with the microarray, Valencia, Calif.-based Specialty Laboratories this week became the first clinical reference laboratory to make the test part of its product menu.
Michael Dugan, vice president and laboratory director at Specialty Laboratories, said that his firm had a head start on its competitors, and by the time LabCorp and Quest announced that they were validating the chip in August, "we were pretty much in the late stages of the development of this."
Competitors said they were validating the AmpliChip "just to keep up with the Joneses because they had heard through Roche or other parties that we were working with them," Dugan said. "So in order to avoid being completely scooped, they decided to come out with a press announcement that said they were going to begin validation."
The deal to offer Roche's CYP450 microarray testing had been "ready to go for quite a bit of time," Dugan said, but the company waited to announce the launch of the service until it was certain the assay would perform as expected.
"We are delighted to be one of the first laboratories in the country to perform this revolutionary genetic test," said David Weavil, chief executive officer of Specialty Laboratories, in a statement, adding that the company will offer the assay "almost immediately to our clients across the country."
The test should be available by order by the end of October, and Roche and Specialty will launch a marketing campaign "to educate clients about the test's value," Specialty said in a statement.
Dugan declined to discuss the size of the market that the test would address or its price.
Roche's AmpliChip CYP450, approved in the United States and Europe in December 2004 and September 2004, respectively, interrogates SNPs within the 2D6 and 2C19 genes of the P450 family, which are responsible for metabolizing a variety of drugs, particularly psychiatric and cardiovascular drugs. At least 41 drugs are CYP2D6 substrates, according to a website developed by David Flockhart, chief of the division of clinical pharmacology at the Indiana University School of Medicine. At least 34 drugs inhibit the enzyme and two are inducers, according to the site.
Although the AmpliChip CYP450 was the first microarray-based product to gain FDA clearance as a diagnostic device, the chip still has to gain a customer base, and aside from the reliability implied by FDA approval, it does not offer customers new tests that they couldn't get through PCR testing, Marcia Eisenberg, LabCorp's vice president overseeing research and development in molecular diagnostics, told Pharmacogenomics Reporter in early August.
LabCorp has been offering PCR-based CYP450 2D6 testing as a diagnostic under Clinical Laboratory Improvement Amendments rules since spring, and plans to begin offering 2C19 testing as well. One difficulty the chip will face is that physicians remain uninformed about how to use CYP450 testing in general, partly because they lack educational material and other information about the microarray and the genes it tests, said Eisenberg.
"We do a lot of evaluations, and we do a fair number of validations," Eisenberg said. "When you're committing the time and effort and resources to a validation, you're doing that with the hope that at the conclusion it will be something you can offer to physicians for their patients."
Chris Womack ([email protected])