# Predicine

> Predicine is a molecular insights company advancing precision oncology through non-invasive, multi-omic liquid biopsy. Founded in 2015 by former Genentech scientist Shidong Jia, the company builds NGS-based assays that read cell-free DNA and RNA from blood and urine to detect cancer mutations, track minimal residual disease, and match patients to targeted therapies. Its flagship PredicineCARE urine cfDNA assay holds FDA Breakthrough Device Designation and is in premarket approval as a companion diagnostic in bladder cancer, developed in collaboration with Johnson & Johnson's Janssen.

- **Founded:** 2015
- **Headquarters:** Hayward, California, United States
- **Founders:** Shidong Jia (Founder, Chairman & Global CEO), Pan Du (Co-Founder & CTO)
- **Team size:** ~89 employees (35% hold PhDs)
- **Products:** PredicineCARE, PredicineBEACON, PredicineATLAS, PredicineALERT, PredicineCARE NGS Kit
- **Notable:** PredicineCARE granted FDA Breakthrough Device Designation (Aug 23, 2022)., Submitted first module of PMA application to FDA for PredicineCARE as a bladder cancer companion diagnostic (2025)., Signed companion-diagnostic collaboration with J&J's Janssen (2024).

## Products & services

- **PredicineCARE** — Comprehensive NGS liquid biopsy assay profiling cell-free DNA (and available as urine cfDNA) across 152+ cancer-associated genes - detecting SNVs, indels, fusions and copy-number variations. FDA Breakthrough Device; in PMA as a companion diagnostic for bladder cancer.
- **PredicineBEACON** — Tumor-naive and tumor-informed minimal residual disease (MRD) assay using blood, urine, or tissue to detect cancer recurrence and monitor treatment response.
- **PredicineATLAS** — Whole-genome / comprehensive genomic profiling liquid biopsy assay for a broad view of the tumor genomic landscape.
- **PredicineALERT** — Methylation-based MRD assay for monitoring therapeutic response.
- **PredicineCARE NGS Kit** — Distributable NGS kit enabling labs worldwide to run PredicineCARE for clinical trials, CDx development, and patient testing.

## Achievements

- PredicineCARE granted FDA Breakthrough Device Designation (Aug 23, 2022).
- Submitted first module of PMA application to FDA for PredicineCARE as a bladder cancer companion diagnostic (2025).
- Signed companion-diagnostic collaboration with J&J's Janssen (2024).
- Presented 9 liquid biopsy studies at ASCO 2024.
- Built proprietary multi-omic (DNA + RNA) liquid biopsy platform reading blood and urine.

## Latest updates

- **2025-09** — Submitted first module of PMA application to the FDA for PredicineCARE urine cfDNA assay as a companion diagnostic in bladder cancer.
- **2024-04** — Introduced the PredicineCARE NGS Kit for global clinical trials, CDx development, and patient testing.
- **2024-01** — Announced collaboration with Janssen (J&J) to develop PredicineCARE as a companion diagnostic in localized bladder cancer.

## Links

- Website: https://predicine.com
- LinkedIn: https://www.linkedin.com/company/predicine
- Twitter/X: https://twitter.com/predicine
- Facebook: https://facebook.com/predicine/

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Profile page: https://yespress.io/predicine
Published by YesPress — https://yespress.io
Last updated: 2026-07-11