PredicineCARE, a urine-based take a look at, is beneath FDA assessment as a companion diagnostic for bladder most cancers, constructing on earlier information and biomarker insights.
PredicineCARE, a urine next-generation sequencing assay, is beneath U.S. Meals and Drug Administration (FDA) assessment after Predicine submitted the primary module of its premarket approval software as a companion diagnostic for sufferers with bladder most cancers, in accordance with a information launch from Predicine.
PredicineCARE is a complicated take a look at that makes use of next-generation sequencing (NGS) to seek out vital adjustments in cancer-related genes. These adjustments can embody mutations, fusions, further or lacking items of genes, or further copies of genes. The take a look at can analyze DNA from tissue, in addition to blood and urine samples, offering clinicians with varied methods to find out about a affected person’s most cancers.
The PredicineCARE urine cell-free DNA (cfDNA) take a look at is a focused model of this know-how. It makes use of a capture-based methodology to detect genetic adjustments resembling single nucleotide variants, insertions and deletions (Indels), fusions and duplicate quantity variations in urine or blood samples. This design helps establish key cancer-related gene adjustments with excessive precision.
“This milestone demonstrates Predicine’s capabilities to develop companion diagnostics on the muse of an FDA-grade high quality and manufacturing system,” Dr. Shidong Jia, founder and CEO of Predicine, mentioned within the information launch. “It displays our crew’s experience and dedication to bringing modern, non-invasive testing options to sufferers and physicians worldwide.”
The primary a part of the applying contains detailed details about how Predicine makes and screens the standard of its checks. This step is vital as a result of it lays the groundwork for growing future companion diagnostic checks that will assist information therapy utilizing each blood- and tissue-based samples.
For the PredicineCARE take a look at in bladder most cancers, the remaining elements of the applying shall be despatched in phases after the primary scientific trial is completed, following the foundations set by the FDA.
On August 23, 2022, the FDA gave the PredicineCARE take a look at a breakthrough system designation. This designation, typically referred to as BDD, is supposed to hurry up the assessment of medical units that might present more practical prognosis or therapy for critical situations, resembling most cancers.
Background Info on the PredicineCARE Assay
The take a look at appears at 152 totally different genes with very deep sequencing, giving medical doctors detailed details about a affected person’s most cancers. It may possibly discover greater than 80 vital cancer-related biomarkers in addition to greater than 9 biomarkers that will assist predict how effectively chemotherapy may work.
After a pattern is taken, it’s despatched to the lab for processing. The outcomes are then analyzed utilizing superior laptop know-how, and sufferers obtain an easy-to-read report that explains what the findings imply for his or her care.
PredicineCARE has been utilized in a number of scientific trials to assist information therapy selections. One part 3 research examined Itovebi (inavolisib) along with Ibrance (palbociclib) and Faslodex (fulvestrant) for sufferers with hormone receptor–constructive, HER2-negative breast most cancers that had unfold and carried PIK3CA mutations. One other part 2 trial, referred to as FIGHT-207, studied Pemazyre (pemigatinib) in sufferers with beforehand handled stable tumors that had FGFR1, FGFR2 or FGFR3 adjustments.
In a breast most cancers research, researchers decided whether or not sufferers had PIK3CA mutations utilizing tissue or blood-based testing. Most sufferers, 92.6% (325 sufferers), had blood-based checks. Of those, 87.4% had been examined with central laboratory strategies resembling PredicineCARE or FoundationOne Liquid CDx, and 5.2% had been examined domestically. A smaller group, 7.4%, had tissue-based testing executed domestically.
Within the FIGHT-207 trial, sufferers gave tissue samples originally of the research and once more if their most cancers progressed. These samples had been analyzed with PredicineCARE to search for adjustments in DNA, resembling mutations or gene rearrangements, which may have an effect on therapy.
Amongst 73 sufferers who had each baseline and development blood samples, 19% developed new FGFR mutations. On this group, 10 out of 14 sufferers (71%) developed multiple resistance mutation. Importantly, these new FGFR adjustments solely occurred in the identical gene that was initially altered, not in different FGFR genes.
References
- “Predicine Submits First Module of PMA Software to FDA for PredicineCARE™ as a Companion Diagnostic Assay in Bladder Most cancers.” Predicine. Information Launch. Sept. 2, 2025.
- “PredicineCARE CLIA validated cfDNA NGS assay,” by Predicine. Information launch; Sept. 3, 2025.
- “Inavolisib-Based mostly Remedy in PIK3CA-Mutated Superior Breast Most cancers,” by Dr. Guilherme Nader-Marta, et al. New England Journal of Medication.
- “Pemigatinib in Beforehand Handled Stable Tumors With Activating FGFR1-FGFR3 Alterations: Part 2 FIGHT-207 Basket Trial,” by Dr. Jordi Rodón. Nature Medication.
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