When Ryan Van Laar created his molecular diagnostics and personalized medicine research company, ChipDX, two years ago, he aimed to provide clinicians with a cheaper and easier way to identify the best treatment solutions for cancer patients. "I had the idea [for ChipDX] thinking about the existing model of clinical diagnostics, where a clinician orders a test and then sends the specimen to a remote laboratory where a genetic profile is generated and then one small set of genes is used to generate a result," Van Laar says. "I started thinking … 'Why can't hospitals generate this kind of info themselves using a standard gene chip, and then have their data analyzed in a standardized and consistent way?'"
Running its tests on the Affymetrix GeneChip microarray platform, ChipDX allows clinicians to upload their data, and — using one of its three online tumor modules — provides doctors with a detailed genomic analysis that may enable them to make accurate treatment decisions.
The new breast cancer prognostic module, BreastGeneDX, is available online, but like ChipDX's other modules, is only available for research purposes and cannot be used in the treatment of patients, though that is the company's eventual aim.
"It's been the goal from day one to have it be something that's used by doctors," Van Laar says. "But there are a lot of things to consider in terms of the regulatory climate for these kinds of tests." The company has done two pre-IDE evaluations with the US Food and Drug Administration to be allowed to offer the tests as investigational tools to clinicians.
In the newest study, published in the Journal of Molecular Diagnostics in May, ChipDX analyzed whole-genome profiles of 447 breast cancer patients and identified 200 genes associated with outcome, independent of standard prognostic measurements, the company said in a release. The genes were used to train BreastGeneDX's predictive algorithm to classify patients as being at high or low risk of recurrence. The efficacy of the three modules — CancerGene DX, ColonGeneDX, and BreastGeneDX — has been confirmed in peer-reviewed studies, Van Laar says. Data from CancerGeneDX — which assists in the diagnosis of metastatic or poorly differentiated tumors — and ColonGeneDX — which helps predict recurrence and overall survival in patients with stage two or three colon cancer — has already been presented in previous papers.
The company is also working on a prognostic and predictive test for non-small cell lung cancer that could serve to determine the probability of a patient's relapsing, survival time, and the chances of a therapy being effective, Van Laar says. The company has independent validation data for the lung cancer module, and a study of its effectiveness will be forthcoming. "The people who have used [ChipDX] have been giving very positive feedback. People are amazed that you can get so much information from one chip," he adds.