PredicineCARE Urine Test Advances in FDA Review for Bladder Cancer

PredicineCARE, a urine next-generation sequencing assay, is under U.S. Food and Drug Administration (FDA) review after Predicine submitted the first module of its premarket approval application as a companion diagnostic for patients with bladder cancer, according to a news release from Predicine.

PredicineCARE is an advanced test that uses next-generation sequencing (NGS) to find important changes in cancer-related genes. These changes can include mutations, fusions, extra or missing pieces of genes, or extra copies of genes. The test can analyze DNA from tissue, as well as blood and urine samples, providing clinicians with various ways to learn about a patient’s cancer.

The PredicineCARE urine cell-free DNA (cfDNA) test is a targeted version of this technology. It uses a capture-based method to detect genetic changes such as single nucleotide variants, insertions and deletions (Indels), fusions and copy number variations in urine or blood samples. This design helps identify key cancer-related gene changes with high precision.

“This milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the foundation of an FDA-grade quality and manufacturing system,” Dr. Shidong Jia, founder and CEO of Predicine, said in the news release. “It reflects our team’s expertise and commitment to bringing innovative, non-invasive testing solutions to patients and physicians worldwide.”

The first part of the application includes detailed information about how Predicine makes and monitors the quality of its tests. This step is important because it lays the groundwork for developing future companion diagnostic tests that may help guide treatment using both blood- and tissue-based samples.

For the PredicineCARE test in bladder cancer, the remaining parts of the application will be sent in stages after the main clinical trial is finished, following the rules set by the FDA.

On August 23, 2022, the FDA gave the PredicineCARE test a breakthrough device designation. This designation, often called BDD, is meant to speed up the review of medical devices that could provide more effective diagnosis or treatment for serious conditions, such as cancer.

Background Information on the PredicineCARE Assay

The test looks at 152 different genes with very deep sequencing, giving doctors detailed information about a patient’s cancer. It can find more than 80 important cancer-related biomarkers as well as more than 9 biomarkers that may help predict how well chemotherapy could work.

After a sample is taken, it is sent to the lab for processing. The results are then analyzed using advanced computer technology, and patients receive an easy-to-read report that explains what the findings mean for their care.

PredicineCARE has been used in several clinical trials to help guide treatment decisions. One phase 3 study tested Itovebi (inavolisib) together with Ibrance (palbociclib) and Faslodex (fulvestrant) for patients with hormone receptor–positive, HER2-negative breast cancer that had spread and carried PIK3CA mutations. Another phase 2 trial, called FIGHT-207, studied Pemazyre (pemigatinib) in patients with previously treated solid tumors that had FGFR1, FGFR2 or FGFR3 changes.

In a breast cancer study, researchers determined whether patients had PIK3CA mutations using tissue or blood-based testing. Most patients, 92.6% (325 patients), had blood-based tests. Of these, 87.4% were tested with central laboratory methods such as PredicineCARE or FoundationOne Liquid CDx, and 5.2% were tested locally. A smaller group, 7.4%, had tissue-based testing done locally.

In the FIGHT-207 trial, patients gave tissue samples at the beginning of the study and again if their cancer progressed. These samples were analyzed with PredicineCARE to look for changes in DNA, such as mutations or gene rearrangements, that might affect treatment.

Among 73 patients who had both baseline and progression blood samples, 19% developed new FGFR mutations. In this group, 10 out of 14 patients (71%) developed more than one resistance mutation. Importantly, these new FGFR changes only occurred in the same gene that was originally altered, not in other FGFR genes.

References

1. “Predicine Submits First Module of PMA Application to FDA for PredicineCARE™ as a Companion Diagnostic Assay in Bladder Cancer.” Predicine. News Release. Sept. 2, 2025.
2. “PredicineCARE CLIA validated cfDNA NGS assay,” by Predicine. News release; Sept. 3, 2025.
3. “Inavolisib-Based Therapy in PIK3CA-Mutated Advanced Breast Cancer,” by Dr. Guilherme Nader-Marta, et al. New England Journal of Medicine.
4. “Pemigatinib in Previously Treated Solid Tumors With Activating FGFR1-FGFR3 Alterations: Phase 2 FIGHT-207 Basket Trial,” by Dr. Jordi Rodón. Nature Medicine.

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