NEW YORK – After selling her most recent venture for millions of dollars, software and life sciences entrepreneur Moran Snir is ready for her next adventure — trying to make it easier for physicians to create care plans informed by patients' genetic results.
Snir in 2019 sold Clear Genetics, a company she cofounded in 2016, to medical genetics company Invitae for an estimated $50 million. Clear Genetics had developed chatbot software to walk patients through the genetic testing process and results, and had been adopted by health systems like Geisinger Health.
Now, she's turning her attention toward bringing genetic information into patient care as CEO of Nest Genomics, a New York City-based company she cofounded in January to develop genetics-focused clinical decision support software that links into providers' existing electronic health record (EHR) systems.
Nest in April raised an $8.5 million seed funding round, and earlier this year participated in Y Combinator — a startup accelerator known for providing a launchpad for successful startups like Airbnb, DoorDash, and Dropbox.
While access to genetic testing has become better — and cheaper — in recent years, "there's now a huge gap in implementation of genetics into clinical practice," Snir said.
Nest's software will ingest a patient's genetic, demographic, and other data from the EHR to create care management plans for patients. The product bases care plans on clinical guidelines from the American College of Medical Genetics and Genomics (ACMG) and other specialty societies, and so far has care plans for hereditary cancers, cardiovascular genetics, and conditions included in ACMG's secondary findings list. Health systems and clinics that are customers of Nest will be able to tailor care plans within their own organization if their processes differ from other guidelines.
Snir said the platform could be used by genetic counselors and other genetic specialists, or by primary-care physicians and specialists managing genetic results for their patients.
The system also encompasses a companion patient-facing tool — a web app that houses educational information about genetic results and reminders to encourage adherence to care plans, such as screenings for various conditions. Patients can use the app to view and share their genetic results with other physicians.
There's a need for tools that help providers and patients navigate genetic results, said David Ledbetter, chief clinical and research officer at the Unified Patient Network, a subsidiary of bioinformatics company Seven Bridges Genomics, and an adviser to Nest. He previously served as chief scientific officer at Danville, Pennsylvania-based Geisinger, which had used Clear Genetics' chatbot, called Gia.
That need will only increase as whole-genome sequencing (WGS) becomes more widely used, since patients will be getting reams of data beyond a typical gene panel, including data that could be useful for other tests later in life, Ledbetter said. He cited a recent preprint study that found a lower rate of inconclusive test results and higher diagnostic yield with genomic sequencing tests when compared to multi-gene panel tests.
But for such a system to be successful, it will have to work within providers' existing workflows — most notably, with the EHR. Physicians "really don't like to go outside of that single EHR environment," Ledbetter said. It's not convenient for a physician to have to open other programs and toggle between them and the EHR, he said.
The Nest team is building integrations with various EHR systems, starting with Epic Systems, Oracle Cerner, and Athenahealth, according to Snir.
Snir said she envisions a future where, as the price of WGS continues to decline, patients can be sequenced once and have that information reinterpreted later on, as new standards of care for genetic variants emerge. DNA sequencing incumbents and startups alike have been competing on sequencing the human genome at the lowest cost.
Managing genetic results can be complicated, in part because guidelines, patient information, and classifications can change over time, Snir said. By updating the software based on new information, Nest can help providers create care management plans based on the most up-to-date available evidence.
Nest proposes to "integrate the results that are actionable today, and then, as new information becomes available, provide those updates to patient and providers," Snir said. The company only provides care plans when prompted by a clinician.
Nest doesn't plan to seek clearance from the US Food and Drug Administration for its clinical decision-support tools, which are rule-based. The company will continue to evaluate regulatory needs based on the final guidance that the FDA released in September, which outlined the agency's approach to regulating clinical decision-support software. Nest will follow the FDA guidance and develop solutions accordingly, Snir said.
The company did a soft launch in August and signed agreements with a handful of health systems and two laboratories to deploy the product, according to Snir. Nest is planning for a full commercial launch in November.
As organizations roll out the platform, Nest will assess whether it affects patients' adherence to care plans and influences their outcomes long term.
Nest is trying to address a "final mile problem" in genetic sequencing, bridging available evidence on what to do with genetic results with tools to suggest such steps to physicians and patients, said Philip Payne, the founding director of the institute for informatics and chief data scientist at Washington University School of Medicine in St. Louis.
The university is in discussions with Nest Genomics about possible codevelopment work, such as creating tools for cancer, neurodegenerative disorders, and rare genetic diseases in children. He said the "best-case scenario" would be to create systems that can one day be deployed with WUSTL physicians, as well as shared with other organizations.
"We have this deep expertise in terms of sequencing and interpreting sequencing data both for research and clinical purposes," Payne said, citing the school's McDonnell Genome Institute. "But like a lot of organizations, we are challenged by closing that gap between sequencing and clinical decision-making."
Ideally, he hopes that tools like those offered by Nest will help frontline clinicians create care plans and manage patients' genetic results, particularly as the industry grapples with a shortage in the clinical genetics workforce.
"This is not something that can just be done by specialists," Payne said. Of course, genetic counseling will be needed for complex results, he added.
Huma Rana, clinical director of the division of cancer genetics and prevention at Dana-Farber Cancer Institute in Boston, said she's preparing to test Nest Genomics with high-risk patients, meaning patients with genetic predispositions for hereditary cancers and who need specialized surveillance, as part of a research project.
That initially will involve interviews with patients to get feedback on the system, before rolling it out as part of a clinical trial.
Dana-Farber has been working with Nest to codevelop and tailor tools that clinicians can use to make it easier to track which patients are due for various screenings and other preventive care. Rana said she's also interested in seeing how patients engage with the patient-facing component and whether it changes their adherence to screenings.
The patient app is "largely an education tool, but also a way to keep track of their 'to-do' list — what they're due for and when they're due for it," Rana said. "Those are really, for us, exciting things."