Medical Device Link.

Originally Published IVD Technology April 2004

INDUSTRY NEWS

The Invader platform allows for flexibility when performing studies involving molecular diagnostics.

Third Wave Technologies (Madison, WI) has introduced a pharmacogenetic assay that detects mutations on the 2D6 gene, and may be poised to compete for the same market segment as Roche’s (Basel, Switzerland) CYP450 Amplichip. 

Third Wave’s Invader CYP450 2D6 panel was designed for use in laboratories during clinical trials of pharmaceuticals to provide information about a patient’s anticipated drug response. According to the company, changes in the 2D6 gene “can cause a 7- to 10-fold decrease in the body’s ability to clear [therapeutic] and other drugs.” 

The panel offers access to several genetic changes that may affect drug metabolism, including single nucleotide polymorphisms (SNPs), single and multiple base-pair deletions, and whole-gene deletion and duplication.

According to Third Wave, one of the biggest advantages of the technology is its flexibility. The SNP and gene-dosage assays are variable and can be tailored to specific testing needs. The Invader platform is a wet-chemistry technology that can be controlled by laboratorians and operated on common laboratory equipment. As such, the test is scalable and customizable, allowing investigators to meet the particular needs of each study. In addition, the system uses both target and signal amplification to enhance testing sensitivity. 

Third Wave representatives believe that their company’s panel offers a clear advantage over the Amplichip. According to the company, “a laboratory is critically limited in the manner (throughput, equipment, mutation selection) in which it can use the Amplichip.” However, Roche representatives seem to believe that their company’s product will come out ahead in the end. 

Like the Invader panel, the Amplichip is currently available for research use in clinical utility studies and pharmaceutical industry-sponsored clinical trials. As such, the tests now have similar target markets (e.g., pharmaceutical companies, reference laboratories, clinical research organizations, etc.) and similar areas of application (e.g., drug metabolism and safety studies, toxicology studies, and pharmacogenetics). However Third Wave’s panel is marketed as a device for research use only (RUO), whereas Roche is in the process of submitting its Amplichip for consideration by FDA as a clinically valid IVD. And this is where Roche believes its test will gain greater value.

The Amplichip will certainly gain a portion of the market that the Invader panel will not be able to enter. If the chip is approved for marketing as an IVD and enters the clinical market, it will be of use to clinicians in “making more-informed decisions when selecting and prescribing dosages for [certain] drugs,” says a Roche spokesperson.

According to Roche representatives, “[IVDs] must meet a number of standards that products used for research use do not have to meet. In this regard, Roche adds significant value [by developing its Amplichip] to meet strict regulatory and diagnostic industry standards including clinical utility, software that translates genotype to phenotype, quality control, performance and sensitivity, international regulatory compliance, and investment in building the market for new clinical applications for microarray technology.”

Not only does Roche believe that its test will be enhanced by its further development for use in clinical applications, but the company also believes in the superiority of the microarray format. According to a company spokesperson, the company “find[s] that microarray technology better supports the robustness and accuracy needed for clinical applications. For example, the AmpliChip CYP450 microarray has redundant probe design, with 240 probes per polymorphism, to avoid interference from yet-unidentified polymorphisms and increase test accuracy.”

Copyright ©2004 IVD Technology