Result

Since first deployment in 2015, Biorep-manufactured components have been used in active NIH-funded clinical trials, peer-reviewed publications, and major cancer conference presentations at leading institutions. Below is a detailed account of Biorep’s role as a manufacturer that has allowed Circulogix to perform the clinial trials and projects

University of Miami / Washington University in St. Louis — AI-Based Automated CTC Detection (U01 Grant)

The most direct citation of the CyteCatch™ trade name in peer-reviewed literature appears in:
Shen C, Rawal S, Brown R, Zhou H, Agarwal A, Watson MA, Cote RJ, Yang C. “Automatic detection of circulating tumor cells and cancer associated fibroblasts using deep learning.” Scientific Reports. 2023 Apr 7;13(1):5708. DOI: 10.1038/s41598-023-32955-0
The study developed a custom in-focus imaging system and deep learning algorithms specifically designed for the uneven surface geometry of microfilter in the CyteCatch™ microfilter slides — achieving 99.3% in-focus image acquisition versus 89.9% for top-of-the-line commercial scanners. The deep learning cell identification method achieved 94% precision and 96% recall for CTC detection, significantly outperforming conventional computer vision methods.
This paper was selected as one of the Top 100 Cancer Scientific Reports papers of 2023 by the journal’s editorial team and received over 3,000 views within its first year of publication. It was funded in part by the U01 (Liquid Biopsy Research Consortium) NIH mechanism — one of the highest-prestige cooperative agreement grant types, used for large-scale collaborative studies.

University of Miami / Washington University in St. Louis — AI-Based Automated CTC Detection (U01 Grant)

While a publication is pending as the investigators are sifting through the large data set that was generated through this 5-year breast cancer prospective clinical trial in stages 1,,2, and 3 of breast cancer, over >320 patients were recruited and >600 samples have been processed from different time points in the study, all using the Bioerp-manufactured Circulogix faCTChecker™, CyteCatch™.

University of Miami — Prostate Cancer Radiation Clinical Trials (Phase II, Registered on ClinicalTrials.gov)

Dr. Alan Pollack’s radiation oncology team at the University of Miami Sylvester Comprehensive Cancer Center explicitly named the Circulogix faCTChecker™ and CyteCatch™ slides in a 2020 AACR abstract covering two registered Phase II randomized clinical trials:

• BLaStM Trial — NCT02307058 (MRI-Guided Prostate Radiation Boost)
• CoMBINe Trial — NCT02997709 (Prostate Radiotherapy Optimization)

The study enrolled more than 215 patients and processed over 500 blood samples using the Circulogix faCTChecker™ and CyteCatch™ slides. CTC enumeration was used alongside single-cell genomic profiling with 10X Genomics Chromium to explore prognostic markers for radiation sensitivity and metastatic risk. Abstract presented at AACR Annual Meeting 2020.
Pollack’s work represents one of the largest prospective deployment of the faCTChecker™ in a randomized controlled clinical trial setting — a pivotal data point demonstrating that Biorep-manufactured systems are reliable enough for randomized oncology trials.

University of Miami / University of Minnesota / Georgetown University / Breast Cancer Research Foundation

Drs. Dorraya El-Ashry (CSO at Breast Cancer Research Foundation and Professor at University of Minesotta and Marc E. Lippman (professor of Oncology and co-directs the breast cancer program at the Lombardi Comprehensive Cancer Center at Georgetown University) used the Biorep manufactured Circulogix microfilter platform — and explicitly credited Circulogix’s cofounders Siddarth Rawal and Richard Cote in the acknowledgments — across multiple breast cancer liquid biopsy studies:

• El-Ashry D, Lippman ME, Miller PC. “Liquid biopsy: expanding the frontier of circulating biomarker discovery and validation in breast cancer.” Cancer Drug Resistance. 2019;2:1215-23. (Funded: Breast Cancer Research Foundation BCRF16098, Prevent Cancer Foundation M1601095)
• Sharma U, Medina-Saenz K, Miller PC, Troness B, Spartz A, et al. “Heterotypic clustering of circulating tumor cells and circulating cancer-associated fibroblasts facilitates breast cancer metastasis.” Breast Cancer Research and Treatment. 2021;189(1):63-80. (Funded: BCRF-19-099, Prevent Cancer Foundation, Sylvester Comprehensive Cancer Center, Masonic Cancer Center institutional funds)
• Abstract PD9-10: “Circulating CAF/cancer stem cell co-clusters bolster breast cancer metastasis.” San Antonio Breast Cancer Symposium (SABCS), Dec 2018.
• Multiple additional AACR Annual Meeting abstracts and SABCS presentations on cCAF identification and heterotypic CTC cluster formation — all using the Circulogix microfilter platform.

The El-Ashry/Lippman group’s work led to the scientific discovery that cancer-associated fibroblasts (CAFs) co-circulate with CTCs in clusters (heterotypic clusters), and that these clusters have substantially higher metastatic potential than single CTCs — a novel finding only possible because the Biorep-manufactured Circulogix size-based microfilter captures both CTC-positive and CTC-negative circulating cells, unlike antibody-based platforms that would miss CAFs entirely.

Third-Party Peer-Review Validation

The faCTChecker™ is independently described in a 2021 peer-reviewed review in Cancers (MDPI) as achieving seven-log leukocyte depletion — among the highest enrichment factors in the field — and as a distinguishing technical advance over track-etched polycarbonate alternatives. Circulogix is specifically identified by name (Hallandale Beach, FL) in this independent academic review, establishing that the platform is recognized by the broader CTC research community beyond the core collaborative network.

GRANT ACTIVITY — Key Circulogix network investigators

The following NIH and foundation grants have funded CTC research directly using the Circulogix faCTChecker™ and/or CyteCatch™ platform:

COMPLETE PUBLICATIONS & ABSTRACTS — CYTECATCH™ / FACTCHECKER™

Important note on timelines: Circulogix first deployed working faCTChecker™ systems by end of 2015. All publications from 2015 onward that reference the faCTChecker™, CyteCatch™, or the Circulogix microfilter platform were using Biorep Technologies-manufactured components. Multiple large-scale prospective longitudinal clinical studies are ongoing across prostate, breast, lung, and bladder cancer — with final long-term follow-up results (5+ years of patient data) expected in coming years, which will generate additional peer-reviewed publications directly citing Biorep-manufactured systems.