Comprehensive genomic integrity assessment for allogenic cell therapies using genomic proximity mapping

The National Center for Advancing Translational Sciences at the National Institutes of Health, under the Department of Health and Human Services, awarded $957,707 to Cytoterra Inc. on July 1, 2026, through the NCATS Program (CFDA 93.350).

Cytoterra will develop and validate a high-throughput genomic integrity assessment platform for allogeneic cell therapies. The project combines genomic proximity mapping technology with whole exome sequencing in a platform called Cytoterra Plus to detect structural variants and single nucleotide variants in cell banks. Current FDA-recommended approaches—cytogenetics and 50X whole genome sequencing—create operational bottlenecks through lengthy turnaround times, specialized labor requirements, or inadequate detection sensitivity. Cytoterra Plus addresses these constraints by providing scalable, cost-effective detection of both large-scale structural variants and high-coverage SNV information.

Work occurs in two principal phases: validation of the Cytoterra Plus assay for use in a regulated environment, and development of a secure, compliant cloud-based platform enabling customers to assess cell bank genomic integrity. Place of performance is Seattle, Washington. The award runs through June 30, 2028.

Abstract

Allogeneic cell therapies hold promise delivering scalable treatments but face extra scrutiny for ensuring a genomically safe product. Currently, FDA recommends cytogenetics for assessing the presence of structural variants (SVS) of oncogenic potential in cell banks. This creates an operational bottleneck for cell bank production as cytogenetic requires a specialized workforce and can take weeks for turnaround. FDA has also recommended 50X whole genome sequencing (WGS) for cell banks as an alternative approach. WGS at this scale is both costly, suffers from inadequate detection of SVS and is moderately sensitive for detection of mosaic single nucleotide variants (SNVS). In this proposal, we describe a scalable, high-throughput approach to capture both large scale structural variants while also provides high coverage SNV information. This approach relies on the combination of genomic proximity mapping (GPM), a technology developed by phase genomics for the detection of SVS and whole exome sequencing in a platform we have named cytoterra plus. To develop a platform for genomic integrity requires the following: aim 1: validate the cytoterra plus assay for use in a regulated environment. Aim 2: develop a secure, compliant cloud-based platform to enable customers to determine the genomic integrity of cell banks.