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Color Partnering With Health Systems Exploring Impact of Genomic Testing on Outcomes, Cost

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NEW YORK (GenomeWeb) – Consumer-focused genomics company Color is entering into partnerships with health systems to grow its business and garner the evidence needed to integrate genetic information into mainstream care.

This week, Color announced it was partnering with NorthShore University HealthSystem to provide genetic testing to 10,000 patients in the primary care setting. Many other health systems are interested in inking similar partnerships to integrate genomics into patient care and track the impact, according to Color and others.

The Evanston, Illinois-based health system decided to launch the DNA10K initiative after it offered testing through Color to a small group of primary care patients to gauge their interest in learning about their genetic risks for cancer and cardiovascular disease, and their ability to process certain drugs. NorthShore, which is offering this testing at no cost to its patients, had anticipated that a few hundred might sign up.

But in under two months, 1,000 patients signed up, representing an adoption rate of more than 40 percent. Doctors also seemed interested in incorporating the results into the care of their patients, which prompted NorthShore to broaden the program to 10,000.

Kristen Murtos, chief administrative and strategy officer at NorthShore, said the goal of the DNA10K initiative is to test out the integration of genomics into primary care practice and assess the clinical utility of this information. "Are we able to demonstrate how this meaningfully improves quality of care for our patients? Does it allow us to cater more proactive care pathways for testing protocols? How does that impact clinical outcomes? And, ultimately, although this will take a while longer, how does this impact the total cost of care?" said Murtos, providing examples of some of the questions NorthShore leaders will be looking to answer within the program.

"The scope of the collaboration is around building a long-term service together and partner around a data-driven proactive healthcare model where genomics is a component," said Color CEO Othman Laraki. "It's really about using genomics as a building block … to help doctors make better decisions as well as engage patients to drive outcomes."

Starting this spring, patients coming in for a primary care visit will find out through the NorthShoreConnect patient portal about the opportunity to get genetically tested. Color uses a next-generation sequencing panel to identify variants associated with the risk of hereditary cancer, hereditary cardiovascular risk, and drug response. Patients will also learn recreational information, such as if they are genetically likely to have bad aftertaste from eating cilantro. This testing costs $250 for customers ordering it online, but through NorthShore patients will receive it for free.

Those who decide to get tested can provide a blood sample during their doctor's visit for analysis, receive educational materials, and discuss any questions they might have. Upon receiving test results, patients can get genetic counseling through Color or speak to pharmacists about pharmacogenetic results.

With patients' consent, results from Color's portal will be imported into the NorthShore EMR, and physicians will be able to use clinically actionable information to inform their care. NorthShore also has genetic counselors to help educate patients about how genetics is influencing their treatments. 

It's worth noting that among the 1,000 patients who received early access to genetic testing, around 60 percent of those offered testing decided not to do it. Murtos said NorthShore didn't collect information on their reasons for not getting tested, but the DNA10K initiative will explore this in more detail.

The collaboration with NorthShore represents a new channel for growth for Color. The company shook up the genetic testing industry in 2015 when it began offering low-cost, clinical grade hereditary cancer risk testing online. Recognizing that many individuals who might benefit from testing weren't getting it due to cost, lack of insurance coverage, or because they didn’t have a doctor who'd order it for them, Color implemented a model where people could initiate test orders online and third-party network doctors would approve them. But because the results of this testing can have serious health implications for the individual and their families, Color also made genetic counseling available for the cost of the service. 

Using this model, Color has quickly expanded its test offerings to report on more cancer-linked genes, hereditary cardiovascular risk genes, and as of last year, pharmacogenetics markers and some traits. The company has also been successfully growing its presence by joining up with self-insured employers interested in promoting wellness among their staff and partaking in research, such as the Women Informed to Screen Depending on Measures of Risk (WISDOM) study comparing different breast cancer screening modalities. Also, last year, Color received an NIH grant to analyze, interpret, and report results from the genomic data collected as part of 1 million-participant All of Us Research Program.

More recently, the company announced it would use low-coverage whole-genome sequencing (lcWGS) to improve polygenic risk scores in non-Caucasian populations historically underrepresented in research. Color is using Illumina's NovaSeq platform to do this analysis and plans to release its first polygenic risk score for cardiovascular disease early this year. 

The collaboration with NorthShore will also facilitate this research, according to Laraki. For consenting patients, Color will be able to analyze samples using lcWGS and use the data in its polygenic risk score improvement project. This lcWGS data could also allow Color to "future proof" other tests, Laraki noted, so patients don't have to be retested as often every time a new PGx variant is added to FDA-approved drug labels, for example.

The company's goal in doing this research and these collaborations is to eventually get to a point where it can give patients and doctors a more "holistic" view of their health risk, as opposed to them learning about the genetic, family, and environmental risks separately. "We'd like to get to where doctors and patients don't need to be doing all the math and extrapolation themselves, but rather it's something that's a core part of how the data infrastructure works," said Laraki.

Health systems are starting to see the value in being able to assess disease risk within their patient population more accurately, and genomics is a key part of that risk assessment. In particular, health systems seem to be recognizing the potential of a low-cost testing service like Color's to improve population health cost effectively. For example, Color has been a proponent of population genetic screening for conditions, such as hereditary breast and ovarian cancer risk, where studies have shown guidelines and insurer's policies are resulting in undertesting and missed opportunities for preventive care.  

Last November, Jefferson Health, which services Philadelphia and parts of New Jersey, partnered with Color to offer free testing to 30,000 of its employees, and since then uptake has been rapid. "It's very important from a population health perspective because we're self-insured," said David Nash, dean of Jefferson College of Population Health at Jefferson Health, during a panel discussion of precision medicine at the JP Morgan Healthcare Conference in San Francisco this week. He estimated that in the first two months of the program more than 6,200 employees signed up.

Color has several collaborations like this in the works with health systems that it will announce this year, according to Laraki. Health systems like Jefferson and NorthShore are starting to shift their view of healthcare delivery and view genetic testing as "a core part of delivering a modern health service," he said.

Historically, the doctor sitting inside a practice or a hospital was where healthcare had to take place, and it was constrained by their time and resources. "One of the biggest opportunities of moving to a more data-driven health model is that technology can enable certain pieces of care delivery to become incredibly accessible," Laraki said. "The ability to take some of those services that needed to be bound by those physical and time constraints can now be taken out of the hospital and delivered digitally. The ability to get large-scale data from patients and get detailed genomic data — there's an increasing realization that you don't need to be completely constrained by onsite resources."

Other barriers to the adoption of genomics in mainstream healthcare have been the lack of evidence showing that testing improves outcomes and is cost effective, but Color's collaborators are hoping to finally gather this data. "As we look at the opportunity to validate the usefulness of genomics at population scale, we're looking for a variety of ways to partner and share information with other leading organizations that are doing this," said NorthShore's Murtos. "We haven't figured out the specifics of what that might look like but are open to advancing the conversation as we look to advance the science forward."

At the JP Morgan conference, Nash noted that Jefferson Health will also be tracking how providing genetic testing to its employees impacts their outcomes and cost of care, and compare those findings with other health systems taking a similar approach such as NorthShore. "Soon you'll see others, like Jefferson, like NorthShore, get on to this bandwagon," he said.