CellCarta and Biofidelity announce an expanded multi-year global strategic partnership, including exclusivity for Aspyre® Lung in clinical trial settings. Building on their existing collaboration announced early last year, the agreement allows sponsors to deploy Aspyre® Lung through a single, coordinated partner, simplifying lung cancer trial execution by reducing the need to manage multiple organizations for the same platform. Lung cancer clinical trials rely heavily on biomarker testing to guide patient enrollment and treatment decisions.

Broad next-generation sequencing (NGS) panels are frequently used for this purpose, but they can take three weeks or more to complete, and 25% of lung cancer samples fail NGS testing. Additionally, the costs can be high compared to other modalities.

As a result, sponsors are seeking more targeted and efficient alternatives. Aspyre Lung can offer this alternative. Purpose-built for lung cancer, it delivers actionable genomic alterations (AGA), enabling sponsors to identify patients for biomarker-driven trial arms or exclude them from non-targeted study cohorts. Aspyre Lung is designed to work with both tissue and blood samples while requiring minimal specimen input. The assay delivers a rapid turnaround time of 4 to 5 days, a success rate as high as 99%, and is more cost-effective compared to commonly used broad NGS methods. “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.” This strategic partnership enables more streamlined deployment of Aspyre Lung across global studies, strengthens coordination between assay expertise and clinical trial delivery, and reduces operational friction for sponsors integrating targeted testing into their programs.

“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.”