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Selventa Expands From Informatics Services to MDx Development With Test to Guide RA Therapy


NEW YORK (GenomeWeb) – Selventa, a company which has largely operated as an informatics/omics service provider to date, is now branching out with a molecular test for rheumatoid arthritis called ClarifyRA, which it intends to develop into a broad profiling tool to help physicians predict patients' responses to a variety of RA drugs.

Last month, the company published a study in BMC Medical Genomics demonstrating that that the assay can distinguish responders from non-responders to anti-TNF treatment. The company now plans to build additional evidence over the next several years, expanding to the prediction of response to other therapies in the RA space, as well as detection of markers that can inform other aspects of clinical care like disease activity, Selventa President and CEO David de Graaf told GenomeWeb this week.

Selventa plans to launch ClarifyRA as a clinical test in 2017, and de Graaf said the company hopes that some of this additional utility will be built in by then. He added, however, that even the anti-TNF assay itself "is so economically attractive and good for patients that it would be substantive enough to launch the test on its own."

The company first discussed its MDx plans with GenomeWeb in 2013, with the hope that it would launch ClarifyRA in 2015.

According to de Graaf, Selventa's interest in developing its own molecular tests, and its decision to target the autoimmune disease area and RA in particular, was borne out of its experience with pharma partners.

In its core business, Selventa has used a multi-omics platform to help pharmaceutical and other partners stratify patients and identify drug targets and mechanisms of action. It has worked with over 25 pharmaceutical and consumer product companies so far, de Graaf said. And as part of this work, the company has tested nearly 1,000 patients with RA in the context of studies intended to determine whether genomic markers are associated with variations in patients' responses to specific therapies.

Selventa has not disclosed the companies or drugs associated with this work, de Graaf said. But the experience in the space illuminated for the firm that there is a clear scientific basis for the existence of genomic subsets with differing response to various RA drugs.

Meanwhile, autoimmune disease struck the company as a prime market in which to advance tests for personalizing medication and medical management.

"We were thinking about how we could use our capability to reduce big data to actionable findings for patients and physicians, and bring that to the patients and physicians themselves rather than just our pharma partners," de Graaf said. "We looked at major areas of need … and decided that the major needs were in autoimmune diseases."

In autoimmune disease, tools and strategies to personalize treatment have greater potential to impact patient outcomes and reduce healthcare costs  than in many other disease areas, de Graaf argued. For example, even in cancer, which has been the poster child for precision medicine and the genomic tests that support it, "the sad story is that patients that are well managed don't outlive those that are not well-managed by all that much," he said. "If you talk to payors of pharmacy benefit managers, that's one thing that comes through immediately."

But in autoimmune disease, its clear that patients that are well managed cost the healthcare system far less than those that are not, which makes the development of tests that can improve that management attractive to payors, to physicians, and to patients.

In RA, there are a handful of drugs available that have similar efficacy and safety profiles but only work for a subset of patients. Without tools to predict which patients should get which treatments, doctors are left cycling their patients through these therapies almost blindly.

And because it can take a very long time to determine if a treatment has not worked — that a patient is not in remission — patients can go long periods of time being treated with therapies that do nothing for them, delaying their opportunity to try an alternate treatment that may actually work.

Meanwhile, according to de Graaf, healthcare systems end up spending between $10,000 and $20,000 more a year more on patients who are not in remission than on those that are.

"So payors are interested, and patients are interested because of their huge frustration with the current system … and physicians are incredibly supportive because currently they have no rationale to prescribe any of 10 different biologics."

Selventa's task with ClarifyRA is to collect the appropriate data to create a test that can serve as a rule-out, picking the patients that are not likely to respond to a particular drug, allowing them to avoid unnecessary treatment and move on to other options, of which there are many, and many more to come.

"We have 70 therapies with RA as a primary indication between phase I and the market at this point and they all need to differentiate themselves," de Graaf explained.

So far, Selventa's published results are limited to anti-TNF treatment. In its study last month the company combined four different gene expression datatsets from anti-TNF drug studies and showed that it could classify patients as responders or non-responders, with an area under the receiver operating curve of about 70 percent.

Moving forward, de Graaf said, the plan is to continue to expand the approach to be able to predict response to other therapies, as well as to inform other aspects of patient care like disease activity monitoring.

"The paper was really a way to substantiate the first part of what we see as the development of this test in a public way — to put it out there … But ClarifyRA wont be fixed in time … we are planning to include other modalities of treatment, like anti-IL6 receptor antibodies, drugs like Orencia and Rituxan … and we know we can have success there because we broadly partnered in similar areas with pharma."

Since the published study, de Graaf said Selventa has expanded the test to incorporate around 1,000 different genes, and transitioned from using gene expression arrays to RNA-seq.

After RA, the company is looking at several other autoimmune disease areas for future test development, including inflammatory bowel diseases, lupus, and multiple sclerosis.

Selventa is not the only company pursuing molecular testing in the RA space. Currently, Myriad Genetics subsidiary Crescendo Bioscience's Vectra DA is used to assess RA disease activity, but Crescendo has been trying to build data showing the test can also predict response to specific drugs.

Diagnostic firm Theradiag has also said it is developing microRNA-based assay that it hopes can predict response to RA therapy.