CellCarta And Biofidelity Expand Global Alliance With Exclusive Aspyre® Lung Deployment, New Strategic Deal Streamlines Lung Cancer Trials And Targeted Genomic Testing

CellCarta and Biofidelity have expanded their global strategic partnership through a new multi-year agreement that grants exclusivity for Aspyre® Lung in clinical trial settings. The collaboration strengthens their joint offering for biomarker testing in oncology studies worldwide.

The partnership builds on their earlier alliance and enables trial sponsors to access Aspyre® Lung through a single integrated provider. This unified model reduces operational complexity by eliminating the need to coordinate with multiple vendors to use a single diagnostic platform across lung cancer trials.

“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.”

Biomarker testing plays a central role in lung cancer research, guiding both patient selection and treatment strategies. While broad next-generation sequencing (NGS) panels are commonly used, they often take 3 weeks or more to deliver results, experience failure rates of about 25% in lung cancer samples, and incur comparatively high costs. These limitations have driven sponsors to seek faster, more efficient targeted testing solutions.

“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.”

Aspyre® Lung addresses this gap with a lung cancer–specific assay that identifies actionable genomic alterations to support biomarker-driven trial arms and patient stratification. The test works with both tissue and blood samples, requires minimal specimen input, and delivers results within four to five days. With reported success rates of up to 99% and improved cost efficiency versus broad NGS approaches, the platform enables smoother global study execution and tighter integration of precision diagnostics into clinical development programs.