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CareDx Works Toward Goal of Becoming Essential Transplant Diagnostics Company


NEW YORK – As CareDx continues building its business around the concept of multi-modal transplant diagnostics, the company is also aiming to show that it's becoming an essential provider of pan-organ transplant services that connect patients to doctors throughout the transplant and recovery process.

On the company's conference call with analysts following its third quarter earnings release, CareDx CEO Reg Seeto said more than 70 kidney transplant centers in the US have now adopted regular AlloSure testing, and more than 320 kidney centers and community practices are using AlloSure.

Importantly, however, he also noted that the attachment rate for the firm's HeartCare graft rejection test is 90 percent. HeartCare provides a comprehensive assessment of graft rejection by combining AlloMap Heart gene expression profiling with AlloSure Heart donor-derived, cell-free DNA.

Attachment rate is used to show the number of units of a secondary product or service sold as a consequence of the sale of a primary product or service. Because it is so high for HeartCare, Seeto said this particularly emphasizes the "value of driving clinical utility through multi-modal innovation," especially since this was achieved in less than 12 months.

He also pointed to the importance of robust clinical data in driving adoption of transplant diagnostics.

"Generating data through multicenter prospective studies continues to be an integral part of how we develop data that can be relied upon by physicians in a real-world setting," he said. For example, he noted that the foundational study for HeartCare that was published in the American Journal of Transplantation captured data from 740 patients across 27 centers. Other companies in the space, meanwhile, have focused on retrospective samples and one- to two-center studies, rather than investing in a larger magnitude of data generation, he added.

CareDx has seen that the larger datasets are more appreciated by doctors and patients, and at the end of September, more than 130 heart centers and practices were using the company's products, Seeto said.

He also noted that the company is executing on its 2021 theme of connecting the patient on their transplantation journey. "Combining our patient care managers with our digital offerings such as AlloCare and TX Hero has helped increase engagement and improve adherence," he said. "Specifically, we continue to see robust uptake of our AlloCare app, which is now available in both the Apple and the Android stores."

The company also continues to develop new multi-modal approaches modeled on HeartCare, and its organ care pipeline now includes KidneyCare, LungCare, and LiverCare.

For KidneyCare, the company is rapidly progressing development, and Seeto highlighted a study published in September in Kidney360 that clinically validated AlloMap Kidney, a gene expression profile developed using candidate genes from the AlloMap assay.

The 14-center study showed that AlloMap Kidney was validated to differentiate immune quiescence from rejection in two independent sample sets using a quantitative scale. Notably, it also showed that AlloMap is complementary to AlloSure, Seeto said.

"Together, these biomarkers offer a comprehensive assessment of kidney health compared to the current standard of care," he added.

For LiverCare, CareDx is now supporting the second largest cohort of patients after its kidney study. It's continuing to enroll patients in the MAPLE (Molecular Assessment and Profiling of Liver Transplant Recipients) study. This is the first study to assess five different modalities of transplant rejection, including donor-derived cell-free DNA with AlloSure, tissue and gene expression with HistoMap and AlloMap, respectively, infection with AlloID, and blood-based micro-chimerism with AlloHeme. The company is also using artificial intelligence to predict allograft outcomes based on clinical parameters.

People began enrolling in the study earlier this year, and the company will provide updates in 2022.

For LungCare, CareDx is planning a long-term multicenter prospective study of multi-modality in lung transplantation called ALAMO. LungCare itself is a combination of AlloSure Lung, AlloMap Lung, AlloID, iBox, HistoMap, and AlloHeme.

Seeto said the release of AlloSure Lung in October is already a right step in the direction of multi-modal diagnostics for lung transplantation, and marks "our next step into being a pan-organ transplant services company."

In response to an analyst's question, Seeto and CareDx CFO Ankur Dhingra pointed out that this approach will sustain the company's business for many years to come because it brings clinical utility and added value to patients and doctors.

"We've looked at the entire landscape, setting and shaping how we want to evolve that narrative in heart, and now in kidney and lung and liver," Seeto said. "So, we have a very specific approach of continuing that clinical utility story. It's so important to do that, because in that way, you can keep on shaping what the reference standards are and also what true meaningful innovation is."

Dhingra concurred, adding, "We also view this as a multiyear journey, not just 2022. The core business, given … the current market penetration — there's certainly a lot of runway in front of us for the next several years, not just 2022."

In a note to investors, Craig-Hallum analyst Alexander Nowak said he is looking beyond what was an "OK quarter" to "what should be an exciting 2022" for the company, highlighting AlloSure Lung and KidneyCare as upsides.

He noted that CareDx's core business of AlloSure Kidney plus HeartCare alone should be sufficient in driving double-digit growth next year. AlloSure Lung, commercial HeartCare pricing, and KidneyCare reimbursement would be incremental to the core, increasing Nowak's bullishness around 2022/2023 estimates for CareDx as being too low.

"With a battle-tested moat, strategic investments paying off, and an attractive pipeline, the thesis of higher growth for longer remains intact," Nowak wrote. "Thus, we say look past the momentary Q3 messiness and look towards an intriguing story 2022 and beyond. We reiterate our Buy on The Transplant Company."