Following its acquisition of Gentris Diagnostics last month, newly-formed ParagonDx is aiming to broaden its reach into the molecular diagnostics market by taking a real-time PCR-based CYP2D6 test through the US Food and Drug Administration and take on industry behemoth Roche.
“What’s currently being offered is the Roche AmpliChip for IVDs, but we do know that a number of labs are still using homebrew methods for [the CYP2D6] test, and we also know that the FDA is considering relabeling the breast cancer drug tamoxifen” to include CYP2D6 testing, ParagonDx CEO Michael Murphy told Pharmacogenomics Reporter this week.
An FDA advisory panel recommended in October 2006 that the agency should update tamoxifen’s label to including information about genetic testing [see PGx Reporter 11-15-2006]. Roche is the only company that offers an FDA-cleared CYP2D6 test.
ParagonDx’s CYP2D6 kit is still in the early “drawing board” stage, said Murphy, formerly CEO of Gentris.
For ParagonDx, developing and launching an FDA-approved test that can accommodate a new tamoxifen label will pit the upstart company squarely against the long-time industry leader. But Murphy said that his test will be different enough from the AmpliChip to gain market share.
“The Roche product is really in the microarray arena, [whereas] all of our products will work under a real-time PCR platform,” Murphy said. He added that the technology does not rely on “any one manufacturer’s equipment but [takes] more of a universal approach.”
Since ParagonDx expects the utility of real-time PCR to rise in the next few years, the company’s overall R&D focus will be to develop PCR-based diagnostics that can overcome microarrays in the market.
“We think there are going to be a number of platform technologies that will meet FDA clearance in the next two or three years,” said Murphy. “The Roche/Affymetrix platform is the only microarray product for IVD [tests]. But we think in the future, in the next two or three years, platform technologies that are FDA-cleared will … utilize real-time PCR.”
Since it is important for patients using tamoxifen to know if they are poor metabolizers, and would therefore be at higher risk for adverse reactions, ParagonDx is “looking toward specifically developing a kit that will outline and identify” these individuals for doctors, Murphy noted. “We’re not worrying so much about the other phenotypes.”
ParagonDx, located in Morrisville, NC, announced Aug. 29 that it has acquired the assets of Gentris Diagnostics, and that it is planning to launch a “series of products” for molecular testing and to file existing homebrew tests for FDA clearance.
Financial details of the deal were not released. However, the company said that Joe Sorge, founder and former CEO of Stratagene, has assumed a controlling stake in ParagonDx and Gentris will retain a minority stake in the new company. Agilent acquired Stratagene in June.
"Molecular diagnostics is an emerging market," Sorge said in a statement. "Small, nimble companies such as ParagonDx will be able to adapt to rapidly changing conditions and bring tests to market that will actually help patients."
Murphy described ParagonDx as a “joint venture between our new investor, Joe Sorge, and Gentris Corporation.” He further clarified that ParagonDx has no affiliation with Agilent, since Sorge sold his interest in Stratagene to Agilent in April.
“As an independent company, ParagonDx has no relationship whatsoever to Agilent,” Murphy said.
Among the assets ParagonDx purchased from Gentris Diagnostics are the first six FDA-cleared CYP2D6 human genomic reference controls and 46 other reference control products currently being sold to reference labs and diagnostic developers.
“The Roche/Affymetrix platform is the only microarray product for IVD [tests]. But we think in the future, in the next two or three years, platform technologies that are FDA-cleared will … utilize real-time PCR.”
ParagonDx will particularly focus on developing and offering FDA-cleared reference controls since the company believes that is an area of unmet need. “There don’t seem to be too many people that are working towards providing high-quality GMP-manufactured reference controls,” Murphy said. “And for most of the tests that are being conducted in the US, we can make the argument that the control is as important as the reagent used to detect a particular variant.
“You can’t really be sure your assay is working, or your platform technology is working, or that your technician is proficient in conducting the test if you don’t have something to measure it by,” he added. “Really, for the quality of your test, the weakest link in analyzing whether your test is working correctly is the positive control.”
Maintaining PGx Focus
ParagonDx also acquired a new in vitro diagnostic designed to determine a safe starting dose for the anticoagulant warfarin. Earlier this month, the FDA required manufacturers of warfarin to update the drug’s label to include genetic testing information [see PGx Repoter 09-05-2007]. ParagonDx’s warfarin IVD will likely be the first product launch in the company’s new iteration.
But with this product, the company will be entering a popular and crowded market. For instance, Kimball Genetics last year launched its warfarin sensitivity DNA test for research/investigational purposes along with the “Pharmacogenetics for Coumadin” study. And Nanogen, Genelex, and Clinical Data each market home-brew tests of their own in this area.
In addition, ParagonDx plans to launch a set of proficiency testing standards. According to Murphy, the company will eventually look beyond personalized medicine toward developing products in the area of inherited diseases, such as familial hemochromatosis, Fragile X syndrome, and genes linked to factor V, factor II, and MTHFR.
Murphy also said the company aims to introduce one FDA-cleared IVD kit and three to four new analyte-specific reagents each year.
“With funding [from Gentris and Stratagene’s Sorge], we now have fuel in the tank and are ready to put the pedal to the metal,” Murphy said. “We have many plans for future molecular diagnostic products. We are in growth mode and will staff up to make these products a reality.”