CellCarta Secures Global Exclusivity for Biofidelity's Aspyre Lung to Advance Targeted Lung Cancer Testing

CellCarta and Biofidelity have announced an expanded, multi-year global strategic partnership that includes exclusivity for Aspyre® Lung in clinical trial settings. The agreement enables sponsors to access the assay through a single, coordinated partner, streamlining trial execution. The assay delivers actionable genomic alterations within 4–5 days with approximately 99% success, addressing key limitations of conventional next-generation sequencing, or NGS.

Biomarker-driven trial designs are now central to lung cancer research, guiding both patient selection and treatment stratification. However, broad NGS panels present notable challenges, including turnaround times exceeding three weeks, failure rates of approximately 25%, and high costs. These constraints can delay trial enrollment and complicate study logistics.

"Becoming the exclusive clinical trial partner for Aspyre Lung is a significant evolution in our partnership with Biofidelity," said Robin Grimwood, SVP of Genomics at CellCarta. “With this agreement, we are establishing a more coordinated framework for deploying Aspyre Lung in global clinical trials and positioning ourselves well for future collaborations on emerging assays, such as Enspyre®, Biofidelity's minimal residual disease (MRD) technology.”

Aspyre® Lung is positioned as a targeted alternative, designed specifically for lung cancer. The assay identifies actionable genomic alterations across key biomarkers, including EGFR, ALK, KRAS, and BRAF, using both tissue and blood samples with minimal input requirements. With a rapid turnaround time of four to five days and high success rates, it offers a more efficient and reliable option for biomarker testing in clinical trials.

"This expanded partnership reflects our shared commitment to simplifying how targeted genomic technologies are integrated into clinical trials," said Barnaby Balmforth, Chief Executive Officer at Biofidelity. “CellCarta brings a proven track record of quality, reliability, and operational excellence in global clinical trial testing. Together, we aim to reduce barriers to adoption and enable sponsors to more easily incorporate targeted lung cancer testing into their trials.”

Beyond immediate operational benefits, the collaboration reflects a broader shift toward faster, more targeted, and cost-efficient genomic testing strategies in oncology drug development. If widely adopted, such approaches may enhance trial efficiency and support more precise patient selection in an increasingly biomarker-driven treatment landscape.