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Principal Investigator: Nancy Lan Guo
Organization: SOSTOS LLC
Fiscal Year: 2024
Award: $400,000
Funding agency: National Cancer Institute
Project Summary
Sostos, LLC has developed a qRT-PCR-based microfluidic 7-gene assay (CATOS-LU) that predicts recurrence
or progression to metastasis of non-small cell lung cancer (NSCLC) in a patient who has undergone resection
for stage 1 cancer without high-risk features at the time of surgical intervention. In retrospective/archived
longitudinal clinical studies, our assay, which was developed utilizing novel artificial intelligence (AI) methods
and validated via our qRT-PCR, next-generation sequencing (NGS), and proteomics, accurately predicted 1) the
risk of tumor recurrence in early-stage NSCLC patients (n>1,600) including patients from a randomized phase
III clinical trial JBR.10 (ClinicalTrials.gov); and 2) the clinical benefits of adjuvant chemotherapy in these patients.
These results support that our technology can 1) identify early-stage NSCLC at high risk for tumor recurrence,
and 2) predict the clinical benefits of chemotherapy in stage 1 NSCLC without high-risk features for earlier
implementation of adjuvant chemotherapy in the course of disease management beyond the current standard of
care. We have accomplished several key milestones to help demonstrate early proof-of-concept during the initial
development of our product. We have submitted a set of comprehensive patent applications to strengthen our
IP for our technology, addressing the clinical utility of CATOS-LU in patient snap-frozen and formalin-fixed
paraffin-embedded (FFPE) tumors, which we have also discussed with the FDA. To help commercialize our
technology, we intend to optimize CATOS-LU in FFPE clinical samples to better fit within the
surgery/pathology/oncology workflow. In this Phase I SBIR project, we will establish a qRT-PCR assay, based
upon our AI-defined 7-gene panel, focusing on stage 1 NSCLC without high-risk features (n=200), for the
prediction of the recurrence risk. To enhance the clinical application and market value of our CATOS-LU within
the standard of diagnostic care, we will develop our CATOS-LU of FFPE tumors in a CAP-accredited laboratory.
The project will test the feasibility of integrating our proposed qRT-PCR assay of FFPE tumors into the existing
hospital workflows for cost-effective in-house testing. The proposed data analysis will follow the FDA instructions
that we have received and the results generated from this project will be submitted to the agency for approval.
We have engaged strategic partners, including a commitment to match this project pending the award of Phase
I. We request Phase I support to test the feasibility of our project and optimize our test to aid physicians in
identifying these high-risk patients in the earliest stages of NSCLC. Ultimately, we intend to obtain CMS
coverage/reimbursement as an LDT followed by FDA approval of our diagnostic test as an aid to diagnosis or
risk score assessment for patients at high risk of recurrence of NSCLC in stage 1 without high-risk features
following primary tumor resection.
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