This week, Cambridge Mass.-based Selventa provided new details about its plans to put its informatics knowhow to use in developing a diagnostic tool for autoimmune diseases such as rheumatoid arthritis and inflammatory bowel disease.
The company also disclosed that it intends to develop similar diagnostic tools for oncology although it will target the autoimmune disease market first, with a test for rheumatoid arthritis slated for commercialization in 2015.
Selventa first announced its intent to move into the Dx market in 2011 as an expansion of its initial business model, which had focused on computational systems biology collaborations with pharmaceutical clients and other collaborators (BI 12/9/2011).
The company said this week that its upcoming Systems Diagnostics or SysDx, tests will tackle an unmet need by helping physicians determine which patients won’t respond to standard therapies, particularly in autoimmune diseases.
Selventa's platform uses multiple information sources including genomic, epigenomic, transcriptomic, proteomic, metabolomic, and clinical records, which are then analyzed in the context of available treatments. The company won’t handle the sample collection or run the molecular assays for the SysDx tests, but instead will provide the analysis of that data and generate a report for physicians.
Selventa believes its multi-omics approach will provide a more detailed picture of patients’ disease states than current omics-based tests, which are “largely limited to the analyses of genetic aberrations," David de Graaf, the company’s president and CEO, explained in a statement.
“The molecular drivers of disease are manifested across thousands of interrelated biochemical pathways,” he added. Therefore, “it is vital that a diagnostic be able to test for a more comprehensive set of disease-relevant biomarkers.”
De Graaf told BioInform this week that the company has collected information for "each individual potential molecular driver of disease," which it is using to develop a molecular footprint that is "the combination of every single potential biomarker.”
“We then use a set of tools to narrow down the number of analytes that in the context of that disease tissue can help us identify whether that molecular mechanism of disease is upregulated,” he said.
Selventa has an internally curated knowledgebase, developed as part of its OpenBel framework (BI 4/1/2011), that contains information from both public and private sources. It has also worked with undisclosed pharma partners to identify “measures” of treatment response that are then combined with different kinds of patient data depending on the disease condition being tested, de Graaf said.
For example, to determine whether a patient with rheumatoid arthritis would respond to anti-TNFs, which are the standard course of treatment, Selventa might gather and explore proteomic and gene transcription data as well as age and smoking status, he said. On the other hand, a cancer patient may require next-generation sequencing data, expression data, and proteomics data in order to make a therapy selection, he said.
Once the analysis is done, physicians will receive a report that provides them with treatment response information and also tells them whether their patients will respond to particular drugs or drug classes, de Graaf said.
Selventa believes it can provide results quite quickly with a “turnaround time [that’s] anywhere from two to five days,” according to de Graaf.
“Its really only limited by how quickly we can profile the blood of a patient,” he said.
For its first two tests, Selventa has decided to focus first on autoimmune diseases because there are fewer competitors in the space compared to a field like oncology, according to de Graaf.
Also, “from a health economic perspective [autoimmune disease] is as important or more important than oncology in many ways because these are patients with chronic diseases who need to be treated over a lifetime and whose disease gets worse,” he added.
More generally, “the ability to wholistically integrate … a variety of different data types and entities,” compared to companies such as Foundation Medicine that rely on next-generation sequencing alone, makes Selventa’s approach to diagnostic testing “relatively unique,” he said.
Selventa’s first SysDx test will be called Clarify-RA and it will predict whether patients suffering from rheumatoid arthritis will respond to anti-TNF therapy.
De Graaf said that the company expects to release the RA test in 2015.
The company is also developing a test for inflammatory bowel disease, dubbed Clarify-IBD, that will identify which patients will and which won’t respond to different treatments.
The commercialization timeline for that test is still undecided, de Graaf said, because the company is actively seeking partners in other disease areas, particularly oncology.
According to de Graaf, Selventa has been working with unnamed partners in the oncology market to identify treatment biomarkers since it first announced its intent to move into the Dx arena in 2011.
So far, “we’ve done quite a bit of work on angiogenesis and drivers of angiogenesis and the ability to identify interventions in angiogenic tumors that will work,” he said.
And the company is still seeking more partners.
Currently, “we are looking for partnerships in breast and lung cancer as well as colon cancer but we’d be interested to take on other areas as well if our partners are there,” de Graaf said.
It isn’t clear at this stage when Selventa will have a therapeutic test for cancer or which kinds of cancers the company will focus on. In this area, “we’ll be led by partnerships,” de Graaf said.
Selventa plans to handle all commercialization activities for both Clarify-RA and Clarify-IDB, de Graaf said. He did not provide specific details, however, about the firm’s commercialization strategy.
“[We intend] to work together with partners to provide a service where a blood sample will be analyzed for the appropriate analytes and [then] we will do the analysis of those analytes and provide back with a report with the underlying clinical evidence to physicians,” he said.
De Graaf said that the company has identified a number of partners who will handle sample collection and analysis but he declined to disclose who they are.
According to de Graaf, Selventa’s foray into the diagnostic market has impacted the way it interacts with its clientele.
“We have really evolved our business in the sense that almost all of our current collaborations are based on the concept of a systems diagnostic,” he said. “What we learn and develop together with our pharma partners informs and helps us as we bring other products to consumers and the other way around.”
For example, pharma companies “are better at collecting clinical data than almost anybody else, especially when it comes to outcomes and understanding whether a drug works or not,” he said. “Most of our patient data access comes through our partnerships with pharma and we provide them back a companion diagnostics opportunity or a patient stratification opportunity or something else that helps them develop a personalized healthcare approach and at the same time we … are able to apply that to help other patients,” he explained.
“Many of the same tools and approaches are used so one business builds on the other [and] we don’t see them really as distinct,” he said.