FDA Approval Is Sought for PredicineCARE Assay as Companion Diagnostic in Bladder Cancer

The first part of a premarket approval application (PMA) seeking the approval of the PredicineCARE urine cfDNA NGS assay as a companion diagnostic for patients with bladder cancer has been complete and submitted to the FDA, according to an announcement from Predicine.1

PredicineCARE is a targeted next-generation sequencing assay designed to detect genomic alterations, including single nucleotide variants (SNVs), insertions and deletions, fusions, and copy number variations in urine cell-free DNA (cfDNA) in the blood and urine.

In 2022, the FDA granted breakthrough device designation to PredicineCARE.2 The assay was developed with the goal of helping identify patients with cancer who may be eligible for targeted therapy in select indications.

“This [PMA] milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system,” Shidong Jia, MD, PhD, founder and chief executive officer of Predicine, stated in a news release.1 “It reflects our team’s expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide.”

Additional modules for the PMA will be submitted in further phases after the completion of a registrational clinical trial.

PredicineCARE Background

The pan-cancer assay has 152 genes integrated into the test with a sequencing depth of 20,000.3 The assay can detect more than 80 clinically relevant oncology biomarkers and more than 9 chemotherapy response biomarkers.

After the sample is collected, it is transported for processing. Following a bioinformatics analysis, test results are provided in an interpretive report.

PredicineCARE has been utilized in multiple clinical trial settings, including the phase 3 INAVO120 trial (NCT04191499) evaluating inavolisib (Itovebi) plus palbociclib (Ibrance) and fulvestrant (Faslodex) in patients with hormone receptor–positive, HER2-negative locally advanced or metastatic breast cancer harboring PIK3CA mutations, as well as the phase 2 FIGHT-207 basket trial (NCT03822117) examining pemigatinib (Pemazyre) in patients with previously treated solid tumors harboring activating FGFR1 to FGFR3 alterations.

In INAVO120, PIK3CA mutation status was determined via local testing of tumor tissue or circulating tumor DNA (ctDNA) using an appropriately validated PCR or NGS test.4 Central testing utilized PredicineCARE in China, as well as the FoundationOne Liquid CDx as the primary method of central testing. During the study, 92.6% of patients (n = 325) received a ctDNA-based test to determine PIK3CA mutation status, including 87.4% of patients who underwent central testing and 5.2% who had local testing. Tissue-based, local testing was used for 7.4% of patients.

During FIGHT-207, patients had tissue collected at baseline and at disease progression, and available samples were run through the PredicineCARE assay in order to detect SNVs, copy-number variants, or rearrangements considered to be known or likely pathogenic, based on the Foundation Medicine database and incorporating COSMIC status.5

In FIGHT-207, 73 patients had post-progression ctDNA samples available to pair with baseline samples, and 19% of these patients acquired 1 or more secondary FGFR mutation in the kinase domain. Among these 14 patients, 10 (71%) developed polyclonal FGFR resistance mutations. Notably, no FGFR alterations were detected at progression outside of the originally altered gene.

References

1. Predicine submits first module of PMA application to FDA for PredicineCARE™ as a companion diagnostic assay in bladder cancer. News release. Predicine. September 2, 2025. Accessed September 3, 2025. https://www.globenewswire.com/news-release/2025/09/02/3142717/0/en/Predicine-Submits-First-Module-of-PMA-Application-to-FDA-for-PredicineCARE-as-a-Companion-Diagnostic-Assay-in-Bladder-Cancer.html
2. Predicine’s liquid biopsy next-generation sequencing (NGS) assay is granted breakthrough device designatuion by U.S. Food and Drug Administration. News release. Predicine. September 20, 2022. Accessed September 3, 2025. https://www.predicine.com/2022/09/20/predicines-liquid-biopsy-next-generation-sequencing-ngs-assay-is-granted-breakthrough-device-designation-by-u-s-food-and-drug-administration/
3. PredicineCARE CLIA validated cfDNA NGS assay. Predicine. Accessed September 3, 2025. https://www.predicine.com/wp-content/uploads/2025/04/PredicineCARE-Flyer-APM-0001-05-2April2025.pdf
4. Turner NC, Im SA, Saura C, et al. Inavolisib-based therapy in PIK3CA-mutated advanced breast cancer. N Engl J Med. 2024;391(17):1584-1596. doi:10.1056/NEJMoa2404625
5. Rodón J, Damian S, Furqan M, et al. Pemigatinib in previously treated solid tumors with activating FGFR1-FGFR3 alterations: phase 2 FIGHT-207 basket trial. Nat Med. 2024;30(6):1645-1654. doi:10.1038/s41591-024-02934-7