Cure Forward Stresses Patient Data Access as Trial Matching Service Matures | GenomeWeb

Cure Forward Stresses Patient Data Access as Trial Matching Service Matures

NEW YORK (GenomeWeb) – After opening up a beta version of its clinical trial matching platform to the public, Cure Forward is making headway in its goal to improve cancer patients' ability to access precision medicine by helping them obtain their genomic data from labs.  

"We can do infinite things," Martin Naley, founder and chief strategy officer of Cure Forward, told GenomeWeb earlier this summer. "But it all begins with people getting their data and being able to apply it different ways."

Naley launched Cure Forward last year with $15 million in venture funding from Apple Tree Partners. During the 15 years he spent in leadership roles at companies like Invitrogen and Life Technologies, Naley often found himself fielding a lot of queries from friends and acquaintances about how to access precision medicine options. 

He told GenomeWeb recently that felt he could always help his friends out by introducing them to someone else — a researcher, a genetic test provider, or a doctor — who could guide them to the next step. "That step always helped them to keep going in their care," Naley recalled, but he also realized that "there is a bigger need out there than just the people who know me."

In an effort to bring precision care to more patients, the Cambridge, Massachusetts-based firm offers services that are increasingly in demand as genomic profiling becomes a critical tool in the fight against cancer. Cure Forward helps cancer patients better understand the molecular features of their disease, connects them to clinical trials, and enables them to find others that have similar tumor profiles. Central to all these services are patients who have access to their medical and test reports, which Cure Forward also helps with.

On the education front, Cure Forward has created on its website "gene stories" for more than 40 genes implicated in cancer. Patients can explore the information to understand, for example, that when a piece of the ROS1 gene fuses with a piece from another gene, the fusions scramble the normal signals within cells and can lead to cancer. 

One of the early lessons for Naley's team has been figuring out how to explain complex genomics concepts in oncology in a way that's accessible to patients. It's not just about "dumbing down" the concepts, Naley said, but about communicating from a place of empathy with people who have just found out they have cancer, may have never heard of DNA or precision medicine, and are "trying to figure out what the heck to do."

"I think we take it for granted as people who have lived in the world of precision medicine for a long time that the public is familiar with these principles of finding molecular targets in your body to fight your cancer," Naley said "But it turns out we're doing a lot of education work for the patients who are coming on to our [clinical trials exchange] platform."

Cure Forward's clinical trial exchange platform enables patients to post their anonymized profiles, including information about their cancer, treatments, molecular data, and location preferences, for 30 days. Clinical trial recruiters using the platform can see these patients during that time and invite them to participate in ongoing research.

Since last year, the company has been privately testing a beta version of the platform, but opened it up for the public to try out a few months ago. During that short time, the platform has gained several hundred registered users, patients are starting to post their information, and there have already been some matches, according to Naley.

The 30-day time frame during which patient profiles are available to recruiters is intended to account for the urgency in cancer care, as well as the challenges of study recruitment. Initially, Cure Forward had set a 10-day time frame, but Naley said that proved to be too quick a turnaround to facilitate matches.

A month allows more time for trial matching, he explained, but is short enough to allow recruiters to identify patients who are still interested in a specific study. It also encourages recruiters to regularly use the platform so they don't miss promising patient profiles that will not be available after a while. Beyond a month, it may be likely that a cancer patient has moved on in his or her care and is no longer interested in a particular trial.

An oft-cited statistic in cancer research is that between 3 percent and 6 percent of eligible patients actually partake in studies. The low participation numbers are particularly challenging for advancing precision medicine, which target molecular markers that are often rare in the population. A number of companies, such as Cure Forward, CollabRx (which last year merged with Medytox Solutions), and M2Gen are trying to address this difficulty by providing clinical trial matching services that factor in patients' molecular tumor profiles. 

"It flips the trial finding [process] upside down," Naley said of Cure Forward's platform. "Instead of looking around for a trial, the trials show up in your mailbox." Trial recruiters don't have to wait for patients to apply to their trails. They can see available patients on the platform and invite them to join based on the information posted.

Cure Forward realizes revenue when patients accept clinical trial invitations from recruiters. Patients can post their information on the platform for free and the firm also doesn't charge recruiters or trial sponsors when they put up information about a study. But once a recruiter invites a patient who matches study criteria, and the patient accepts, that consumes tokens. Cure Forward provides recruiter clients an initial set of tokens with which to start using the platform, but once those runs out, they have to buy more.

In June, the company inked its first trial recruitment collaboration with a large pharmaceutical company, Novartis, which has said it will use the clinical trial exchange platform to identify participants for its studies. US Oncology Research, which offers more than 200 clinical trials around the country and provides care to more than 800,000 patients through its network, also said it would use Cure Forward's trial matching platform. According to Naley, Cure Forward has inked similar partnerships with other biotechs and a large contract research organization, but some of these deals aren't yet public.

The company is developing a community portal where patients can find others with similar molecular features driving their cancer, so they can "problem solve their disease together and learn from one another's experiences," Naley said.

Cure Forward hopes to launch a marketplace where patients can shop for second opinions, he added. Cancer patients will be able to share their clinical and genomic information with doctors and ask if they have ideas beyond the course initially recommended. The company will also create tools with which patients can easily donate their data to research.

All the services provide by Cure Forward, whether it's education, trial matching, or facilitating connections with doctors and patients, start with the patient having access to his or her medical data. This philosophy even dictates which labs Cure Forward partners with.

The company has inked partnerships with eight labs, which offer tumor profiling on next-generation sequencing panels, as well as exome and whole-genome sequencing. These labs have also committed to providing patients who request it access to their full data set generated through testing, which can contain information on benign genetic variants or variants of unknown significance that may not be included in a test report.

Naley said these labs share Cure Forward's guiding belief that "if you put data in people's hands, they may be able to do constructive things with it."

Cure Forward doesn't recommend specific tests to patients or that they get tested at a particular lab. Even if patients get tested from a non-partner provider, the company has created a data request letter they can use to ask for all the information that lab has in a structured format.

In this way, Cure Forward is also educating patients about their data access rights under the Health Insurance Portability and Accountability Act. Changes to the HIPAA Privacy Rule two years ago gave individuals the right to receive copies of their "designated record set" from HIPAA covered entities. A DRS, as defined in the HIPAA Privacy Rule, comprises medical, billing, payment, claims, health plan enrollment, case management, and any other records used to make decisions about an individual.

The US Department of Health and Human Services explained in a "Frequently Asked Questions" document this January that a DRS maintained by a genetic testing lab includes not only reports but also the "underlying information generated as part of the test." Moreover, labs that are HIPAA-covered entities and conduct NGS have to provide individuals who request information related to genomic testing "with a copy of the completed test report, the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test." 

Earlier this year, four patients who had previously received testing from Myriad Genetics exercised their rights under the HIPAA Privacy Rule and requested their DRS, specifically information on all genetic variants identified during testing. This exercise, which the patients carried out with the help of the American Civil Liberties Union, demonstrated that within the lab community and among patients there may be limited awareness of how broad patients' data access rights really are under HIPAA. 

Initially, Myriad provided the patients with their test report, because, according to the company, this is usually what patients ask for. After conferring with the Office for Civil Rights and getting further clarification on what's included in a DRS, Myriad provided patients with the information they were requesting. A Myriad spokesperson noted though that no patient — before the four patients guided by the ACLU requested their DRS — had ever asked for anything beyond their test report.

In an effort to better comprehend data access rights under HIPAA, Cure Forward has consulted lawyers about the Privacy Rule and appreciates that "all data that's created [on a patient], whether it's reported out in a test report or not, is part of the designated record set," Naley said. "That's what a patient has a legal right to access."

Using Cure Forward's data request form patients are having success getting their data sets from labs, he added. "Even from places that are not our partner and have been reluctant to provide any data, using our data request letter we've been able to retrieve full data sets that go beyond what is in a patient's diagnostic test report," Naley said.

He claimed that the information from the DRS has even helped some patients get treatment options that they wouldn't have otherwise. The company, however, would not put GenomeWeb in touch with any of these patients. "HIPAA is about more than privacy. It's about data access," Naley said. "And we help people exercise that right to get that data from anywhere." 

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