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CareDx Expanding Diagnostic Tech Into Cell Transplant Monitoring


NEW YORK – With 2020 behind them, CareDx executives made it clear this week that they see nothing but growth opportunities ahead for the company in 2021 as it expands its diagnostic test offerings beyond organ transplant monitoring and into cell transplant surveillance.

On a conference call with analysts following the release of the company's fourth quarter and full year earnings this week, CareDx President and CEO Reginald Seeto said the firm is investing heavily in patient care, whether that's hiring additional patient care managers, deploying new software to make it easier for clinicians to track their patients' progress, or developing new diagnostics to cover as many different transplant patients as possible.

Seeto highlighted the success CareDx had in 2020 with its mobile phlebotomy offering, RemoTraC, which it launched in March as COVID-19 infections began to accelerate, to enable remote home-based monitoring of transplant patients. Approximately 40 percent of CareDx's testing volume originated from its mobile phlebotomy business in Q4, Seeto said.

The company is also planning to offer patient care managers as a "white glove premium service" to handle pre-transplant, peri-transplant, and post-transplant patient issues, he added. It already offers patient care managers to look after patients before their transplant, and to call them after their surgery.

"They've had a significant impact on the business and the way that we operate," Seeto said. "When we have the ability to call patients at a transplant center, the adherence rate achieved by our patient care managers is double of that than when a center, for example, calls up the patients to schedule. So we know by offering this, the patient care managers have had a lot of success in driving and maintaining adherence."

The company is also driving hard into the software space to make doctors' lives a bit easier, and as a way to add more transplant centers to the list of providers using its tests. It recently launched AlloCare, an app designed to allow clinicians to track their patients' progress and health activities, manage their medications, and communicate with the company's patient care managers to schedule lab tests.

Last month, CareDx also acquired TransChart, a provider of electronic health records software, to expand its digital offerings. Included in that acquisition was TXConnect, a provider of human biologics donation and transplantation software. This will allow nephrologists and dialysis centers to electronically submit referrals to transplant programs, and will let them follow and assist patients through the transplant waitlist process and through transplantation, the company said.

"This really provides an opportunity for us to build a connection with the dialysis centers," Seeto said. "This is something that is truly exciting as we continue along that patient journey continuum."

Most important, however, are the company's offerings in the cell transplant surveillance space. Last April, CareDx launched AlloCell, a surveillance solution for patients who have received engineered-cell transplants for allogeneic cell therapy. When it reported second-quarter earnings last August, the firm said it had recorded its first ever revenue from AlloCell, and had fielded several offers from pharma and biotech companies for partnerships to test the product.

"With allogeneic cell therapy being a rapidly growing clinical development area in oncology, cardiovascular, neurological, autoimmune, and infectious diseases, we believe our surveillance solution is a perfect partner for companies developing allogeneic cellular therapies," Seeto said during the Q4 call.

CareDx partnered with Atara Biotherapeutics and presented data on AlloCell at the annual Transplantation and Cellular Therapy meeting earlier this month, he added, showing that AlloCell has potential to be used as a standardized pharmacokinetic assessment tool in clinical trials. CareDx also presented data at the TCT meeting on its AlloHeme and AlloSeq HCT tests for chimerism and recurrence surveillance of stem cell transplant patients, he added.

"We're very excited about the potential of AlloCell, though we're in very early stages to this significant greenfield opportunity," Seeto said. "AlloCell is really an exciting opportunity and it's part of the future longer-term growth as we see it replicating what we did with AlloSure by creating a new market with universal surveillance to allogeneic cell therapies."

Importantly, he added, there is currently no standard surveillance test for allogeneic cell therapy. "Some companies are trying their own internal home brews in terms of how they can do the monitoring," Seeto said. "What we're doing is a universal standard that can be applied to any therapeutic as we measure that therapeutic cell concentration. And I think that's why it's really exciting."

In a note to investors on Thursday, BTIG analyst Sung Ji Nam said CareDx has multiple years of strong double-digit revenue growth ahead of it, driven by an expanding value proposition for the transplant ecosystem and a strong product portfolio "encompassing pre-, peri-, and post-transplant management, commercial strategy targeting the entire transplant ecosystem (centers, patients, community nephrologists, etc.), and growing digital capabilities."