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Precision Health Company ixLayer Introduces Platform to Streamline Genetic Test Delivery

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NEW YORK – Precision health company ixLayer this month rolled out a new platform that it claims can simplify the relationship between test providers, physicians, and patients. The company's offering is intended to reduce the IT burdens associated with launching a new test, and can be tailored for consumer genomics firms, healthcare companies, and population health initiatives.

"Historically, every organization's thought process has been to rely on their own IT teams and developers ... and it usually took between one and two years to create all of these functionalities," said CEO Pouria Sanae. "We realized the commonality among all of these organizations and created a platform that each organization can leverage and [use to] pick a functionality that matches their need within two months, at a fraction of their own cost," he said.

Sanae co-founded ixLayer in 2018 in San Francisco. He previously served as director of product management at Helix, his entry point into the genetic testing market. Prior to Helix, he held senior roles at Yahoo and Flickr. He noted that these experiences played a crucial role in the development of ixLayer. "We put a lot of emphasis on having a patient-centric view," he said.

As the name of the firm suggests, the concept of ixLayer is to create a layer of technology that makes it easier for providers to deploy new tests, for clinicians to order them and integrate results into existing infrastructure, and for patients to access their data and understand it using infographics, illustrations, and other content.

"At the moment, the results delivered in genetics amount to a scary-looking PDF that even doctors have difficulties understanding, never mind the patients," Sanae said. "We all need to strive to change that."

Currently, ixLayer employs 16 people though by the end of the first quarter, that should grow to 23, Sanae said. The company is backed by venture capital firms Pear VC, FundRx, and Village Global; and investment and consulting firm Maky Zanganeh & Associates.

These investors and others took part in a seed round last year. According to Sanae, ixLayer is planning a Series A round for later in 2020.

ixLayer formally announced its platform last week but has actually been supporting some clients since 2018 in consumer genomics, genetic testing, and population health. Some early partners include ADx Healthcare, a Bellingham, Washington-based provider of a genetic Alzheimer's screening test; Baebies, a Durham, North Carolina-based firm that offers newborn screening services; and Well Aligned, a provider of health and wellness consumer tests.

ADx was actually one of ixLayer's first customers and engaged the startup to assist with a next-generation sequencing-based service it had introduced on the Helix platform. ADx CEO Steve Booth said via email that Helix and ADx launched the Alzheimer's disease test in August 2018. As part of the process, ADx determined that it could not on its own provide the application programming interface (API) necessary to roll out the test using the Helix online ecosystem.

The company then began working with ixLayer to assist with building the infrastructure to support the test launch, specifically in the areas of user experience, user interface, and market development. "It's clear that we would not have been able to handle the launch without them," said Booth.

He noted that in order to preserve the user experience for customers, ixLayer and ADx had to make it possible to "seamlessly reach across four platforms" to gather the needed information for the user: Helix, for the lab results; PWN Health, for genetic counseling and medical test authorization; ixLayer, for test ordering and results delivery; as well as the ADx website.

Booth said that the company is working with ixLayer to launch a second genetic test later this year.

According to Sanae, the initial work with partners like ADx and Baebies allowed ixLayer to develop software to give patients access to testing. But once it had that architecture in place, the company decided that bringing physicians into the picture was the next logical step.

"There is a real disconnect between the labs that are developing amazing new categories of testing and the physicians who have to dissect all of this new information in front of them," Sanae said. "These tests often take forever to reach patients and studies on clinical utility are measured in years, not months," he said.

The company now aims to deploy its platform within health systems and physicians' offices to assist with the ordering and delivery of genetic testing information. The firm has also developed tools that will enable the integration of genetic testing data into electronic health records, so that the results are accessible if and when tests are ordered by patients directly.

While Helix partners like ADx have partnered with ixLayer, one advantage of using the company's platform is the ability to sidestep partnering with major providers like Helix, Color Genomics, or 23andMe, which have typically been engaged for large population health studies, such as the Healthy Nevada Project, for instance, or the Mayo Clinic-led Tapestry study.

"The issue is that if you use those companies you are basically tied into their systems and they also share ownership of the data generated and also share the relationship with the patients or consumers," said Ruby Gadelrab, CEO of MDisrupt, a Santa Clara, California-based consulting company that has advised ixLayer.

Gadelrab said that ixLayer's platform enables users to build their own delivery systems instead and customize their user interface. This gives them more leeway in deciding on technology platforms and report designs, and gives them more autonomy when it comes to their datasets.

According to Sanae, ixLayer consists of four "building blocks" tailored to patients, physicians, genetic test providers, and healthcare organizations. These include tools for reaching patients, obtaining consent for testing, reporting results and generating action plans, integrating data into EHRs, providing genetic counseling and clinical reports, offering integration with existing laboratory information management systems, hosting bioinformatics pipelines and large genomic datasets, and collecting health data before, during, and after testing.

The firm charges a monthly licensing fee for its services which covers, among other things, cloud scaling and product updates, security, and cyber liability insurance of up to $2 million per incident, Sanae said. All of its tools are compliant with the US Health Insurance Portability and Accountability Act and the European General Data Protection Regulation.

Innovation partnership

Last week ixLayer also acknowledged that it has been supporting the Innovation Institute and Invenio Genetics to roll out genetic testing using its platform. The Innovation Institute is a La Palma, California-based joint venture company owned by several hospital systems in the US. Invenio, a portfolio company of the Innovation Institute, was established last year to commercialize a pharmacogenomic test across the US.

Invenio CEO Michael Spine said that much of the initial work on the pharmacogenomic test was done at Avera Health, a regional health system based in Sioux Falls, South Dakota, that operates also in Minnesota, Iowa, Nebraska, and North Dakota. Avera already offers a pharmacogenomic test called GeneFolio that tests for 17 genes that can impact the metabolism of medications for pain, depression, statins for cholesterol, and certain types of blood thinners. The new test is based on GeneFolio and runs on an Illumina microarray platform.

According to Spine, Invenio is planning to launch the test via Avera in April before making it more widely available in the US and, potentially, internationally. Avera currently tests about 2,500 people using Gene Folio each year. Invenio aims to double that by next year, and to run about 200,000 tests within five years.

As more healthcare systems adopt Invenio's test, ixLayer will be there to build the architecture needed to make the test available in different contexts. "Our partners may want this test to be associated with their health systems," said Spine. "ixLayer will help us on the back end," he said. "Even though we have different faces, all of that data will be aggregated in the same place."

Sanae said that ixLayer has been working with Avera and Invenio to tailor the ixLayer platform to their needs ahead of the launch. "It's a challenge," he noted. "Each lab that we integrate has its own homebrew LIMS, and each physician has their own APIs," he added. "But, on average, a new client can launch with us within eight weeks. Why invent the wheel over and over again?"

Looking ahead, next month ixLayer will also begin formally offering support to partners focused on remote clinical research and population health studies.

By working with ixLayer, users will be able to better enroll patients for genetic testing as well as connect data on study subjects, the company claims. Customers in this segment include population health programs and biopharmaceutical companies, Sanae said. This will allow them to more roll out testing without making significant investments in IT infrastructure.

ixLayer is also looking to add reimbursement capability to its platform later this year "to determine eligibility before purchasing a health test, and [to integrate] with existing reimbursement services, so that our customers can utilize it," said Sanae.

The company is also looking outside the US for partnerships. Sanae said that ixLayer is already in discussions with a "large population health program" in the UK about rolling ixLayer into its system. He said that it has also had similar discussions with Japanese partners.

"The UK will be the next big country we focus on," he said.

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