Scipher Medicine has revealed its intention to roll out an early physician access initiative for PrismTcell, a molecular treatment response signature test utilizing a blood sample to forecast how rheumatoid arthritis patients will react to abatacept.
In Plain English: The Clinical Takeaway
- What it is: PrismTcell is a blood test that uses a molecular signature to predict whether a patient with rheumatoid arthritis will respond well to abatacept, a targeted T-cell activation inhibitor.
- How it works: The assay evaluates transcriptomic profiles, single nucleotide polymorphism genotyping, and baseline clinical characteristics to match patients with the most effective therapy early in their treatment journey.
- Clinical impact: Validation studies demonstrated an approximately twofold higher ACR50 response rate among patients identified by the molecular signature compared to those without it.
Expanding Precision Diagnostics in Immunology
The new test broadens Scipher’s selection of precision medicine offerings, pairing with PrismRA—a blood-based diagnostic that anticipates non-response to tumor necrosis factor inhibitors among rheumatoid arthritis patients and holds CMS reimbursement approval. “We are excited to contribute to the future of precision diagnostics in immunology with the launch of PrismTcell, as we continue our mission to match the right treatments with the right patients,” says Reg Seeto, CEO of Scipher Medicine, in a release. The company’s expansion into immunology diagnostics now extends toward precision therapeutics, with future plans to develop therapies designed to leverage molecular signatures to predict treatment response.
Clinical Validation and Upcoming Data Presentation at ACR Convergence 2026
Creation and validation of the diagnostic test relied on multi-modal data encompassing baseline clinical characteristics, single nucleotide polymorphism genotyping, and transcriptomic profiles. The development and validation groups encompassed a retrospective rheumatoid arthritis registry, retrospective studies sponsored by Scipher, and the prospective PREDICT study (NCT06390709), which spanned over 40 clinical locations across the US as a two-year, multi-center study. The American College of Rheumatology’s annual meeting, ACR Convergence 2026 in Orlando, Florida, is slated to feature the presentation of these validation results. The presentation, titled “A Molecular Treatment Response Signature Improves Efficacy of T-Cell Therapy in Rheumatoid Arthritis,” will be delivered by Ryan T Phan, PhD, during poster session C on Nov 10.
| Study / Program Element | Details & Methodology |
|---|---|
| Diagnostic Target | PrismTcell blood test for abatacept response in rheumatoid arthritis |
| Validation Trial | PREDICT study (NCT06390709), a two-year multi-center trial across more than 40 clinical sites |
| Efficacy Metric | Approximately twofold higher ACR50 response rate in signature-identified patients |
| Data Presentation | ACR Convergence 2026, poster session C (Nov 10), presented by Ryan T Phan, PhD |
Clinical Perspectives on Treatment Positioning and Therapy Selection
Targeted testing aims to help inform therapy selection when initial treatments fail. “When a patient doesn’t respond to their first biologic, deciding which treatment to try next can be challenging,” says Mark Tan, MD, a rheumatologist practicing in Long Island, New York, in a release. “PrismTcell has the potential to help us identify patients who are more likely to respond to abatacept before starting treatment, so we can make more informed decisions and get patients on the right therapy sooner.”
The clinical validation trials also featured feedback from investigators highlighting how molecular signatures help position treatments earlier within the care continuum. “In my practice, abatacept is not typically a first choice after failure of an initial biologic, which is often a TNFi. However, in MTX-inadequate responders, the evidence supporting abatacept as a first-line biologic option is compelling,” says George Karpouzas, MD, professor of medicine at David Geffen School of Medicine at UCLA and chief of the division of rheumatology at Harbor-UCLA Medical Center, in a release. “If we could better identify, before treatment, which patients are most likely to respond to abatacept- especially if not poised to respond to TNFi- it would give physicians greater confidence to consider the therapy earlier in the treatment journey.”
Commercial Rollout and Laboratory Testing Infrastructure
Scipher targets the beginning of Q1 2027 to initiate the PrismTcell Early Access Program, marking the assay’s introduction to clinical care and the start of its commercial rollout. Participating clinical practices can utilize the program to order the blood test for adult rheumatoid arthritis patients currently being considered for abatacept treatment. Diagnostic testing will be performed in Scipher’s CLIA-certified, CAP-accredited laboratory located in North Carolina.
