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SARS-CoV-2 Pandemic Driving Labs to Build Out Information Systems to Support DTC Testing

NEW YORK – The SARS-CoV-2 pandemic has led a number of labs to build out their information systems to enable direct contact with consumers, a trend that could accelerate even after the outbreak is over.

With large national labs like Quest Diagnostics and Laboratory Corporation of America dipping their toes into the direct-to-consumer testing business in recent years, some smaller labs are looking to follow suit. Many, however, have lacked lab information systems capable of working with home-collected samples.

Jennifer Bull, chief operating officer at Bellingham, Washington-based lab Northwest Pathology, said that last year her lab was looking to build out a DTC business with a planned focus on women's health. Northwest didn't have the e-commerce and other informatics tools it needs to support this sort of operation, though.

So, Bull began discussions with LIS developer LigoLab in late 2019 to put together a system that would help the lab move into the DTC space. In February of this year, Glendale, California-based LigoLab presented Bull with an initial version of its TestDirectly DTC portal.

The TestDirectly tool allows patients to create an online account through which they can find nearby collection sites, schedule appointments, fill out and place test orders, and receive test results. The system creates electronic requisitions with unique barcodes that can be used to label and then check a sample in at the lab and track it as it is processed and run. After the test is run, results are delivered to an online portal and patients are notified they are ready for viewing.

While Northwest and LigoLab were originally focused on the tool as a facilitator of routine DTC testing, it has proved key to Northwest's SARS-CoV-2 testing business.

Early in the pandemic, "we ended up landing a contract with the state of Florida to do about 200,000 [SARS-CoV-2] tests for them," Bull said, noting that the contract was for testing long-term care residents and employees. "And for the employees, we couldn't just give the results back to the employer, they had to go back to the employee directly."

"Like many labs, we didn't have a mechanism set up in our LIS to be able to handle that type of workflow, she said. LigoLab hurried to get the TestDirectly tool up and running to provide that capability for Northwest.

"We ultimately tested 190,000 people in Florida using TestDirectly integrated into our LIS," Bull said.

Joe Nollar, AVP of product development at San Diego, California-based revenue cycle management and lab informatics firm Xifin, said that he saw the COVID-19 pandemic added to demand for DTC testing and direct-to-patient reporting of test results that has been building in the industry for years.

"The market is obviously trending towards offering a lot more direct-to-consumer testing," he said. "The last few years, some of our clients have been doing direct-to-consumer testing for carrier screening or genetic health risks and pharmacogenetics, and I think that it is definitely expanding into more routine testing."

SARS-CoV-2 testing has accelerated this trend, Nollar said. "There's been a big uptick in direct-to-patient reporting for COVID-19."

He added that testing programs for schools and employers in particular require the capability to handle patient-initiated testing and reporting of results directly to patients.

One of the keys to managing this process was allowing patients to provide electronically all the information they would traditionally give through a cumbersome manual process, said LigoLab CEO Suren Avunjian.

"What would happen is a patient would go to, say a drive-through [test site] and there would be paperwork to fill out, so someone is sitting there filling it out, wasting the patient's time and creating a huge line at the collection facility," he said. "Then that paperwork travels to the lab and someone else has to transcribe this information with mistakes and so on. Once you get over like 500 to 1,000 orders a day, that becomes a nightmare. Especially if you have a lab that went from a couple of hundred specimens a day to 20,000, 25,000 specimens coming in every day."

"Now when [a sample] comes to the lab, it's already accessioned in our system and barcoded, and we simply scan it in and put it straight to testing," Bull said. In addition to the lab's Florida work, Northwest is using TestDirectly to help handle samples from drive-through DTC SARS-CoV-2 testing sites it is running in partnership with its sister company ADx Healthcare.

But while SARS-CoV-2 testing is the major driver of DTC testing currently, Avunjian said he expects this market will continue to grow even after the pandemic recedes. LigoLab began development of the TestDirectly module prior to SARS-CoV-2 because of requests from several of its clients who were looking for LIS tools that would let them enter the DTC market. He said he expected that the customer environment post-COVID-19 would be even more favorable for this kind of testing.

"People are going to get used to this model because that is how so much COVID testing is done, and then with just the overall fear of going into crowded places people are doing things as digitally as possible," he said. "So, it's absolutely going to be a growing market, I think."

Nollar agreed. The pandemic "will make it a more pervasive industry-wide trend for other types of routine testing, whether it is influenza or other kinds of rapid PCR tests to diagnose different diseases, including women's health and a broad array of different infectious diseases," he said.

Quest Diagnostics and LabCorp both launched consumer-initiated testing services—QuestDirect and Pixel by LabCorp, respectively—in late 2018, in response to what the companies said were changing patterns in how consumers use healthcare, including increased interest in wellness and health monitoring applications and growing demand for more patient convenience.

During Quest's recent Q3 2020 earnings call, Steve Rusckowski, the company's president, chairman, and CEO, said he expected the pandemic would contribute to the growth of its QuestDirect business.

"We have a nice platform that has been building up volume and we feel there are going to be more opportunities in front of us… and given the circumstances [it] will continue to have a lot of interest from consumers," he said.

Quest CFO Mark Guinan noted on the call that beyond the advantages in terms of providing customer convenience, the company's DTC tests also have higher price points than the equivalent traditional tests, though he noted that DTC remains a small part of the company's overall test volume.

The move of national labs into the DTC space has inspired smaller and more regional labs like Northwest to begin to explore that segment of the market. Another factor is the rise of third parties like Everlywell and Any Lab Test Now that partner with labs to provide DTC testing. In fact, Bull said a major reason her lab began exploring the DTC space was the arrival of an Any Lab Test Now location at a nearby grocery store.

"People started asking us, if I go there are you doing my testing?" she said. "And we were like, no, we're not, it's going somewhere else. And that kind of sparked the question for us, is there interest in this [among Northwest's customers]?"

Bull said that when the lab looked into it, informatics was the biggest gap it needed to address in order to provide DTC testing.

"We already send test supplies out. We already have a receiving department and are used to receiving samples. We work with FedEx and commercial airlines [to ship samples]. All of that was in place," she said. "It was the ability to have the patient enter in their own information, to be able to collect their insurance information, their payment information, to schedule their appointment, and to be able to handle all that data coming in that was the biggest obstacle."

LigoLab's Avunjian said that since launching the TestDirectly tool this spring, it has signed up around two dozen labs as customers for the platform.

Xifin doesn't offer a DTC component as part of its own LIS software but many of its clients have either developed their own portal for such testing or have partnered with other outside vendors for DTC portals, Nollar said, noting that it works with its clients to integrate these portals with its LIS.

Moving forward, the company "would continue to maintain and work with those vendors and providers that specialize in those portals and services that allow consumers to order lab tests directly," he said, adding that Xifin might in the future develop its own DTC portal.

Bull said she sees the current DTC market as largely consumer driven with demand highest for wellness-type tests that are not necessarily part of core routine testing. "People aren't wanting to order their own [complete blood count] or things like that," she said, adding that drug and sexual transmitted disease testing were also areas where interest in DTC options were high.

"Do I think [DTC testing] is going to bring in the bulk of our revenue? No, probably not," she said. "But as we looked to grow our lab and expand our test menu, it was one of those things that made sense to add to our business model."