NEW YORK – In order to meet the demand for diagnostic testing during the coronavirus pandemic, telehealth startup ixLayer has developed a new workflow to help improve access to SARS-CoV-2 tests, as well as increase testing capacity.
Originally the company had offered a service for clinical lab partners to offer diagnostic teseting. But following a recent consumer alert from the US Food and Drug Administration, ixLayer has modified its workflow to only support a patient's physician as part of the in-person specimen collection.
The alert was about at-home testing for the coronavirus SARS-CoV-2, in general, and did not name any specific company.
According to ixLayer CEO Pouria Sanae, the firm wants to provide a digital platform for patients seeking a rapid diagnostic testing service, which he said will be powered by physicians, health systems, and clinical labs. "If there is any clinical lab out there, we can get their validated test up and running for patients or doctors."
Cofounded by Sanae in 2018, ixLayer initially launched a platform earlier this year to help streamline the process for getting access to genetic tests offered by providers while minimizing the IT challenges. The firm also offers a direct-to-consumer (DTC) platform that allow patients to order nutrition and wellness testing.
For the past month, however, ixLayer has been responding to the sharp uptick in demand for COVID-19 diagnostic testing — with the biggest interest from clinical labs and health systems — by adapting its testing platform to scale for COVID-19 testing.
"For the last 10 days, we've been back-to-back with calls from clinical labs [trying to] get their test up and running," Sanae said. "In the next two months, [our customers] will be health systems who want to offer the tests to its patients."
Sanae noted that ixLayer can launch a clinical partner on the firm's digital platform within 48 hours.
Sanae highlighted that ixlayer's platform is compliant with the US Health Insurance Portability and Accountability Act and the European General Data Protection Regulation, and it works with clinicians in all 50 states, and integrates a patient's electronic health and medical records.
Before the FDA alert – which warned consumers about "unauthorized, fraudulent test kits" for SARS-CoV-2 testing – a patient wishing to know if they have the coronavirus could have theoretically ordered a COVID-19 test from one of ixLayer's clinical partners through ixLayer's online platform. A primary care physician (PCP) who believed their patient might have contracted the virus would have also been able to use the ixLayer telehealth platform to order a COVID-19 test.
As soon as a test was requested, ixlayer's online platform would guide the patient through an interactive patient portal, which then determined if they required urgent medical attention and should call 911; should take the test based on described symptoms; or were not eligible for the test because they did not exhibit symptoms. The platform would share health information with the patient's primary care physician or a physician network for review and approval. If the clinician believed the test was not a good fit for the patient, ixLayer would then reimburse the patient for the test and provide information about their test rejection.
However, if the patient was determined at high-risk, ixLayer's platform would set up a sample collection process at a fulfillment center, which either shipped a collection kit overnight to the patient's home, guided the patient to the nearest testing center, or scheduled an appointment for a collection agent to visit the patient's home and retrieve the sample.
For a sample kit mailed out to the patient, Sanae explained that ixLayer would have offered online instructions to help the patient collect a sample for analysis.
As a result of the FDA alert, however, ixLayer is now moving to an approach that supports the physicians in specimen collection. Instead of allowing patients to initiate the process, ixLayer's platform will require clinicians to request a test for patients they suspect are exhibiting COVID-19 symptoms. However, ixLayer is still determining the exact sample collection process at this time.
While that process will alter slightly, due to the FDA guidance, ixLayer's platform still plans to send the sample to a clinical lab partner that has a validated COVID-19 diagnostic platform. Sanae argued that one of the system's strengths includes its access to several different labs, which he believes allows patients to receive their results as quickly as possible.
After a clinical lab analyzes the patient sample, it sends the data back to ixLayer, which generates a report for the PCP through a secure online portal.
Depending on the test results, the patient's PCP will then contact the patient and decide further clinical steps. Sanae believes the platform could help doctors quickly identify patients who need to stay at home, as well as track positive cases and the spread of the virus.
The platform also provides information containing real-time demographic data and maps of locations of new outbreaks in order to better understand the spread of COVID19.
"Through both charts and mapping, the ixLayer platform can create modeling tools needed by organizations like the US Centers for Disease Control and research groups to track the spread of COVID-19 between communities and identify demographic groups [impacted] the most," Sanae explained. The platform "can report on numerous test suppliers simultaneously, allowing a centralized dataset and modeling structure."
In light of the FDA's alert issued last week about at-home testing, a number of firms that had planned on making their own at-home tests available to the public have reportedly postponed their launches. As ixLayer attempts to amend its diagnostic workflow to only support physician collection as part of the process, Sanae acknowledged that the FDA alert has impacted the firm's workflow, but that the firm is managing to adapt to the agency's rapidly evolving policies for COVID-19 testing.
"Originally, our thought was to have a physician log into the portal and order a test that could be shipped to the patient's home, but [we] are now thinking how to deal with specimen collection," Sanae explained. "This will mean screening patients upfront and only suggesting that tests are ordered on patients with symptoms or those who have been directly exposed to someone who is positive."
Sanae said that with the change, doctor's offices will know how to directly handle the patients with symptoms. He noted that the company can facilitate the kit arriving at the physician's office, pending "demand and capacity with the lab partners the firm we have signed up."
Sanae also emphasized that ixLayer will not offer any COVID-19 test offered by a clinical lab that does not follow the laboratory diagnostic test pathway.
"There are physician networks validating these tests and the labs they're performed in," Sanae said "Since we work closely with these physicians, we would not launch tests by anybody that has not been approved by these networks."
Sanae added that he believes the FDA's stand on at-home testing will be short-lived and the rules will be loosened if the coronavirus pandemic worsens acutely. If that were to happen, "we will be ready to support patients initiating the process," Sanae noted.
Sanae declined to disclose the price of ixLayer's COVID-19 testing service due to several variables – such as whether the test is reimbursed through a government payor versus a private payor, or if the specific assay offers diagnostic information about other flu types. However, he noted that on average, ixLayer receives about $2 per test processed through the service.
Sanae also declined to disclose the names of the 12 clinical labs that are developing validated COVID-19 tests and that ixLayer is working with. He noted that ixLayer has been speaking with a La Palma, California-based joint venture called the Innovation Institute to create an ordering process for COVID-19 tests.
Michael Spine, CEO of Invenio Genetics, one of Innovation Institute's portfolio companies, said that Invenio has been working with ixLayer to offer the COVID-19 testing portal to its regional health system members, including Sioux Falls, South Dakota-based Avera Health.
ixLayer in the process of working with its initial health system partner and expects to launch the online platform at some point next week.
"The platform will be used to screen patients and then help facilitate the testing process, whether initiated at a drive-through or a clinic," Sanae said. "The idea would be to first screen patients online and test only those who were appropriate."
John Moore, CEO and founder of ChilMark Research, a IT analyst firm to help health organizations adopt, deploy, and use IT to improve patient experience, highlighted that certain IT companies — such as Ada Health, Babylon, and Conversa — also offer surveillance tools similar to ixLayer's for COVID-19 testing, some of which are rule-based and others that integrate an artificial intelligence component.
However, Moore acknowledged that such tools offered by groups like ixLayer may not be perfectly accurate, as "you don't know if they're indeed a carrier or asymptomatic." If the patient isn't visibly ill, physicians must hope they will instead self-isolate.
He also noted that there has been an uptick in cybercrime during the pandemic from dubious companies claiming to offer diagnostic or telehealth services.
"People with no morals will abuse the telehealth system, and patients who are not all the wiser are then taken advantage of by these bad actors," Moore warned. "There's certain data privacy fears, as it's questionable what these firm's [diagnostic] sources are, and if they've truly validated test protocols and more."
Because the demand for COVID-19 diagnostic testing in the US has soared in the past few weeks, Sanae acknowledged that ixLayer has paused its other services, such as consumer health and wellness testing. While ixLayer is fulfilling prior orders for these services, the firm is not taking any new clients other than for COVID-19 testing for now. That way, Sanae believes the firm can support as many COVID-19 patients as possible.
Moore noted that the surge in telehealth resources could leave a lasting impact on the need for such a service in the healthcare space, depending on the scope of the coronavirus pandemic.
"If [COVID-19] clears up by Easter … then it most likely [would] not," Moore noted. "If this goes on for a couple more months or more, which is highly likely, then it will stick."