NEW YORK (GenomeWeb) – GenomeDx announced last week that patients who receive its prostate cancer risk analysis can now also order genetic testing for hereditary cancer risk mutations provided by Color Genomics.
The announcement is the second of its kind featuring Color. This February, liquid biopsy firm Cynvenio described a similar arrangement in which clinicians can now test breast cancer patients for alterations in the 30 genes on Color's hereditary cancer panel alongside Cynvenio's ClearID breast cancer test.
In both cases, patients gain the ability to order Color's hereditary test through the company that is already investigating their cancer. Color still analyzes and returns results through its established systems, but rather than having to seek out hereditary testing from what is now a very large number of providers, customers of both Cynvenio and GenomeDx who want germline analysis for their patient can just order it directly through those companies.
None of the three firms have discussed how this arrangement works financially, but GenomeDx President and CSO Elai Davicioni said that the agreement between Color and his firm is reflective of a mutual desire to increase access to hereditary cancer testing.
According to Color's VP of Global Sales, Marketing, and Operations Darrin Crisitello, both GenomeDx and Cynvenio provide "really important" testing to individuals currently diagnosed with cancer.
And though each company has a different focus and different models for offering their tests, the similarity is that both serve patients for whom Color could be used to determine an underlying hereditary contribution to their disease.
"It's important to individuals, but also to family members. And I think the value for offering [our test] in conjunction is specific to our mission of getting hereditary cancer testing to as many people as possible," Crisitello said.
"This is just another way to do that … it’s a vehicle for that patient."
Companies have increasingly approached Color, he added, requesting that the firm perform germline testing on their behalf.
"That’s not true to what we want to do and I don't think providing [our results] to a company that doesn’t have all the safeguards in place that we do is the right thing to do," Crisitello said.
"We are really diligent about this, about making sure [individuals] understand what both positive and negative results mean," he added. "And in different patient populations not everyone may understand that so if it's not conveyed really clearly it can be problematic."
Being able to maintain that control — but still bundle its test with companies who interface directly with patient populations that are candidates for germline testing — gives Color the best of both worlds.
"We believe very strongly that the way we convey results is the right way to do it whether we are on our own or if Cynvenio or GenomeDx is providing the testing," Crisitello explained.
Partnering with Cynvenio, which offers blood-based tests for advanced breast cancer patients, Color is reaching a group of patients and physicians for whom hereditary genetic testing is much more familiar, not to mention embraced by professional guidelines.
In contrast, GenomeDx — whose principal tests are for prostate cancer patients — opens up a customer base for Color in which germline testing is not yet widely embraced.
According to Davicioni though, this is poised to change significantly with an expected update next year to the NCCN guidelines that hopefully more clearly endorse hereditary mutation testing in men with family history, early onset of disease, or other known risk factors.
GenomeDx, he added, has been increasingly fielding questions, either directly from patients or from physicians, about germline testing, especially among younger men who receive results from its Decipher test that indicate a higher risk for aggressive prostate cancer.
"Men who are in their late 40s or early 50s, and come back with a high result, the question they ask is do I have to worry about my kids?" Davicioni said.
"Time will tell, but at least from physicians in our channel, especially as guidelines change and there is more awareness, patients are asking about this," he added. "Prostate is behind breast. We are at the beginning of this journey. So it makes sense in some ways even more to do it in partnership."
Also, unique to Color's agreement with GenomeDx is the fact that it provides for data from Color's germline analyses to be integrated into GenomeDx's Decipher GRID database.
GRID (which stands for Genomics Resource Information Database), collects and collates the full microarray data for every patient analyzed using the company's Decipher tests.
Researchers can then apply to access that deidentified genomic data alongside information on patients' clinical characteristics and outcomes, allowing retrospective analyses of existing or novel signatures.
All physicians who order a Decipher test can access the Decipher GRID data for their own patients on a research-use basis. Those who want to use more of the resource must sign user agreements, though access is free for all non-commercial investigations.
Data from Color will further expand the resource, with some immediately exciting possibilities, Davicioni said. For example, information on BRCA and other genes associated with DNA damage and repair pathways could help develop strategies to predict response to PARP inhibitors and other emerging drugs.
Color's Crisitello said that though the firm can't discuss details of possible collaborations, adding similar partnerships with other cancer diagnostic companies could be a possibility.
"If there is a scenario where we can increase access to more patients and provide them hereditary genetic testing we would want to do that, complementary to our goal of providing access to as many people as possible," he said.
"We think there are many companies out there that offer tests [for which] we think germline testing could be a great adjunct … so if we see opportunities to do that we'd move forward with those," he explained.