We define and measure digital endpoints alongside pharma and academic partners, generate one of the largest real-world monitoring datasets in oncology, and publish outcomes that hold up to clinical and regulatory scrutiny. This is the evidence base you can build on.
Working with pharma and academic partners across multiple advanced therapy programs, we build digital endpoints in three moves. We define the standard, validate signal detection, and characterize how it behaves in the real world.
Before a digital signal can be an endpoint, the field needs a shared, submittable definition. We set that standard with our partners.
The first formal ontology for digital biomarkers of cytokine release syndrome, co-developed with pharma and academic partners, a foundation for regulatory-grade digital endpoint submission.
Medberry C, Angel C, Wilkes M, et al. J Med Internet Res. 2025;27:e71956.
We show that a digital signal captures the clinical event it stands for, accurately and reliably enough to qualify as a fit-for-purpose endpoint. Depending on the endpoint, that can mean detecting an event earlier, measuring it more precisely, or anchoring it to the underlying biology.
Continuous wearable monitoring detected the signs of CRS a median of 7 hours earlier than standard inpatient care, opening a measurable window for earlier intervention and a novel trial endpoint.
Wearable-derived temperature signals achieved sensitivity of 0.72–0.75 and specificity of 0.76–0.80 for CRS detection, demonstrating the analytic viability of digital endpoints.
Cytokine profiling identified IFN-γ as a consistent early biomarker, with temporal concordance to wearable temperature signals, enabling multi-modal endpoints.
Rajeeve S, Wilkes M, Zahradka N, Tomalin L, Pan D, et al. Detection of cytokine release syndrome using wearable devices and cytokine profiling following CAR-T therapy for myeloma. JCI Insight. 2026.
Signals behave differently across sites and cohorts. We map that variation so it can inform protocol and dosing decisions.
We measured alarm pattern timing, frequency, and clinical consequence across multicenter cohorts, real-world data that informs dosing window design and monitoring protocol optimization.
Across our partnered trial portfolio we have collected these endpoint types. The catalog reflects the breadth of what we measure, not the design of any single program.
Captured across Phase I through IV and commercial programs, in label-expansion and pharmacovigilance contexts, spanning CD19 and GPRC5D CAR-T, bispecifics, and T-cell engagers, in single- and multi-country cohorts ranging from roughly 40 to 225 patients.
Across outpatient CAR-T and bispecific programs, continuous monitoring has been associated with high survival, contained toxicity, and fewer hospitalizations.
30-day survival across 209 outpatient CAR-T patients monitored with our platform, across four FACT-accredited sites in a large US health system.
Majhail NS, Cox T, Zahradka N, Wilkes M et al. JCO Oncol Pract. 2025. doi:10.1200/OP-25-00062.
Grade ≥3 CRS despite 70–79% any-grade CRS incidence, suggesting continuous monitoring enables early detection and timely intervention before toxicity escalates.
Majhail NS, Cox T, Zahradka N, Wilkes M et al. JCO Oncol Pract. 2025. doi:10.1200/OP-25-00062.
Reduction in all-cause hospitalization during bispecific antibody step-up dosing, with all CRS events identified by remote patient monitoring and all Grade 1 in severity.
Rajeeve S, Wilkes M, Zahradka N, et al., Korde N. Effectiveness of remote patient monitoring in enabling outpatient step-up dosing for bispecifics at a large academic cancer center in the USA. Blood. 2025;146(Suppl 1):2751.
Our internal research team collaborates with our partners to further the science and best practices of advanced therapy delivery beyond the hospital.
