The molecular test could help identify patients more likely to respond to abatacept, with early access expected in 2027.
Scipher Medicine announced the planned launch of an early physician access program for PrismTcell, a blood-based molecular treatment response signature test designed to predict patient response to abatacept for rheumatoid arthritis.
Abatacept is a T-cell activation inhibitor used to treat rheumatoid arthritis. In clinical validation studies, PrismTcell demonstrated an approximately twofold higher ACR50 response rate with abatacept among patients identified by the molecular signature compared to patients without the signature.
The diagnostic expands Scipher’s portfolio of precision medicine tests, joining PrismRA, a blood test that predicts non-response to tumor necrosis factor inhibitors in patients with rheumatoid arthritis and is approved for reimbursement by CMS.
“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. “Our commitment to rheumatology and the broader immunology field is now extending beyond diagnostics as we plan to enter precision therapeutics and intend to develop therapies designed to leverage molecular signatures to predict treatment response.”
Clinical Validation and PREDICT Study Findings
The diagnostic test was developed and validated using multi-modal data, incorporating transcriptomic profiles, single nucleotide polymorphism genotyping, and baseline clinical characteristics. Development and validation cohorts included a retrospective rheumatoid arthritis registry, Scipher-sponsored retrospective studies, and the prospective PREDICT study (NCT06390709), a two-year, multi-center trial conducted across more than 40 clinical sites in the US.
Validation findings will be presented at ACR Convergence 2026, the annual meeting of the American College of Rheumatology held in Orlando, Florida. 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.
Mark Tan, MD, a rheumatologist practicing in Long Island, New York, notes that targeted testing can 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 Tan 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.”
Investigators in the clinical validation trials also pointed to the utility of molecular signatures for positioning therapies earlier in care pathways.
“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.”
Laboratory Testing and Early Access Rollout
Scipher plans to launch the PrismTcell Early Access Program in early Q1 2027 to introduce the assay into clinical practice and begin commercialization. Under the program, rheumatologists at participating clinical practices will be able to order the blood test for adult patients with rheumatoid arthritis who are being evaluated for abatacept therapy.
Diagnostic testing will be performed in Scipher’s CLIA-certified, CAP-accredited laboratory located in North Carolina.
