By Allison Proffitt 

June 9, 2017 | For researchers, well-characterized human samples are valuable commodities. And that’s exactly what Novaseek Research delivers to its customers Novaseek’s CEO Kate Torchilin told Clinical Informatics News last month at a meeting in Boston. “Having the biospecimen is very important here,” she said. “You can only deduce so much from data.”

Torchilin says Novaseek’s Clinical Data Network for Research (CDNR) platform is applicable to several types of research questions. For instance, she said, you want to be sure a hamster model reflects patients, but you’re not ready for clinical trials. “That's where our capability of getting access to well-categorized and consented patient cohorts works.” Alternatively, after big data study perhaps a researcher is looking for Crohn's patients with high blood pressure to do an observational study. And about half of Novaseek’s customers are diagnostics companies validating assays that need access to patients with documented patient histories.

In every case, Novaseek’s CDRN provides researchers with well-categorized cohorts of consented patients while allowing hospitals and physician groups to share their data and samples with researchers. The CDRN is generally disease agnostic, and includes patient data on metabolic disorders, cardiology, and oncology. We are not venturing into ultra-rare disease, Torchilin said.

The platform interfaces with EHRs in real time, and Novaseek is continuously monitoring hospitals with which it partners. Researchers enter requests into the platform, Torchilin explained, for example a researcher may be starting a diabetes study, and is seeking a group who has had a certain test within the past year to watch for the next 100 days and see plasma as it changes.

“The more direct interaction and transparency the researcher has [with the platform], the better it works,” she explained. The CDRN provides researchers with aggregated information to let them start asking initial questions. If they have a hypothesis, they can log into the platform and see some bigger numbers right away, she said. “Then they can ask to collect plasma on 50 males with X and Y and Z labs [and a specific] phenotype.”

People can waste a lot of time and money asking for things they'll never get, Torchilin said. She said that up to 30% of requests will never, ever be matched, maybe “because a researcher has specified a lab result that is totally out of range”. But the CDRN platform lets researchers see why a request is unlikely to be matched, and makes suggestions to help them choose better criteria. But they are only suggestions. “We don't make them change their criteria, it may be the most important criteria [to that research project],” Torchilin said.

Consented Observation

For this type of observational study, “the patient doesn't know they are in the trial,” Torchilin explained. There are no additional trips to doctor, no medications to take, no additional bloodwork. Most patients in a medical system will never match to an observational study, but if they do, there's no extra work for doctor or patient.

So how does consent work?

“We have an umbrella IRB protocol that's already approved,” Torchilin said. Patients’ participation in the studies is covered by a “front door” consent that most sign as soon as they enter the medical system. “Patients can match to multiple studies as long as there is no change from standard of care,” she said.

Consent is generally indefinite, though some states and hospital systems have their own rules. Maine, for instance, requires re-consent every two years, Torchilin said. There are always mechanisms available for patients withdraw.

This is the type of consent and observational study that large hospital systems—Torchilin mentions Mass General, Geisinger, and Kaiser—already use. Novaseek’s hospital customers are smaller, next tier institutions who don’t have the funding or infrastructure to set this up for themselves.

For instance, in mid-April Novaseek announced its partnership with CoxHealth, one of the nation’s top 100 integrated health systems, and one of the largest hospital systems in Missouri and surrounding states. CoxHealth will use Novaseek’s CDNR “platform to procure, with patient consent and authorization, biospecimens and associated real world clinical data in pursuit of accelerating medical innovation,” the hospital system said in a statement.

“Through our partnership with Novaseek Research, we are able to expand our patients’ range of options and enable them to participate in advancing scientific research,” said Chris Schulze, director of clinical research for CoxHealth in the same statement.

Sometimes these systems prefer to keep research requests internal; others open their samples to external biomedical researchers. Novaseek uses a semi-federated data model, Torchilin said; most data are kept locally within the hospital firewalls.

Specimen Logistics

Torchilin views the company, really, as a logistics and IT company. Novaseek has no wet-labs. It provides kits and shipment materials to systems sharing biospecimens externally, but doesn’t repackage and handle samples. “We are integrated with FedEx,” Torchilin said.

The three-year old company is based in Massachusetts and has ten staff so far. Torchilin reports one million patient lives, “all available to be consented.”

Torchilin, who has a doctorate in biochemistry, worked for several years at Beth Israel Deaconess Medical Center in business development before moving to Thermo Fisher to launch new diagnostics and new products. Founding Novaseek, she said, was a logical progression. “I started observing the bottlenecks, where things have moved and where they are still so rudimentary,” she said.