The company that reads cancer out of a vial of blood - or urine - before a needle ever touches a tumor.
Hayward, California. A wordmark on a lab door, and behind it a room where roughly a third of the staff hold a PhD. The product is not a machine you can photograph - it is a way of listening to fragments of DNA and RNA drifting in body fluid, and deciding what they mean.
Predicine, Inc. sells something more boring and more powerful than it sounds: a way of reading the genome of a tumor without cutting into it. It is a molecular diagnostics company, which means its customers are drug makers, clinical trials, and the labs that run its assays - and its real product is a decision.
Here is the ordinary version of a cancer diagnosis. There is a tumor, and to learn what is wrong with it you send a surgeon after a piece of it, and then you wait. Predicine's bet is that most of what you needed to know was already circulating in the patient's blood - and, in its more distinctive work, in their urine - as free-floating fragments of cell-free DNA and RNA shed by the tumor itself. Sequence those fragments deeply enough and you can name the mutations, the fusions, the amplifications. No needle into the tumor required. In the trade this is called a liquid biopsy, and it is one of the more genuinely useful ideas in modern oncology.
The company was founded in 2015 by Shidong Jia, an MD-PhD who had spent years at Genentech figuring out which molecules to aim cancer drugs at, and Pan Du, its chief technology officer. Jia's insight, roughly, was that he had spent a career on one half of the equation - the therapy - and that the other half, the test that tells you which patient the therapy is for, was where the leverage actually lived. A drug with no companion diagnostic is a key with no lock. Predicine builds locks.
Those numbers describe a mid-stage diagnostics company, not a unicorn, and that is a useful thing to know about Predicine. It has raised tens of millions, not hundreds. It employs enough scientists to run CLIA-certified, CAP-accredited labs and to bring nine studies to ASCO 2024, the field's largest oncology meeting - but it is not trying to out-market the giants of the space. Its scarce resource is credibility with the FDA and with pharma, and it has been spending accordingly.
Predicine's products are named like navigational instruments - CARE, BEACON, ATLAS, ALERT - which is either good branding or a very literal description of what a test that finds cancer in a fluid is supposed to do.
The comprehensive NGS assay. It profiles 152+ cancer-associated genes from cell-free DNA - single-nucleotide variants, insertions and deletions, fusions, copy-number changes - and, in its more distinctive form, from urine. It carries FDA Breakthrough Device Designation and is in premarket approval as a bladder cancer companion diagnostic.
A minimal residual disease assay - the test that answers the question every cancer survivor is really asking: is it coming back? It works tumor-naive or tumor-informed, using blood, urine, or tissue to catch the earliest molecular signs of recurrence.
The wide-angle lens. A comprehensive genomic profiling assay built to map the broader landscape of a tumor's genome rather than a targeted panel of known drivers - useful for research and discovery work.
A methylation-based MRD assay for monitoring how a patient is responding to therapy over time - reading epigenetic signals rather than only the sequence itself.
In 2024 the company did something quietly strategic: it packaged PredicineCARE as a distributable NGS Kit, so that labs around the world could run the assay themselves for clinical trials, companion-diagnostic development, and patient testing. A service becomes a product; a product travels further than a lab in Hayward ever could.
Most liquid biopsy companies read DNA. Predicine reads DNA and RNA from the same sample - a multi-omic approach - and that matters more than it sounds. Some of the most clinically important events in cancer, particularly gene fusions and certain resistance mechanisms, are easier to catch in RNA. If you only read one language, you can miss half the sentence.
The other distinctive move is where Predicine looks. Blood is the default medium of liquid biopsy. Predicine has leaned into urine - urine cell-free DNA - which for cancers of the urinary tract, like bladder cancer, is about as close to the source as a non-invasive sample can get. It is a less crowded lane, and it is exactly the lane where the company's biggest regulatory bet is being placed.
On August 23, 2022, the FDA granted PredicineCARE a Breakthrough Device Designation - a status that speeds review for tests addressing serious conditions. Designation is a promising start, not a finish line. What follows is the long, unglamorous work of a premarket approval application, and Predicine has been filing it in phases: the first module of its PMA for PredicineCARE as a bladder cancer companion diagnostic went to the FDA in 2025, with subsequent modules to follow as its registrational trial completes.
Behind that filing is a collaboration announced in January 2024 with Janssen, the pharmaceutical arm of Johnson & Johnson. The two are developing the PredicineCARE urine cfDNA assay as a companion diagnostic to identify localized bladder cancer patients who may benefit from targeted therapy. For a mid-stage diagnostics company, a pharma partnership is the fastest legitimate road into the US companion-diagnostic market - Predicine has said it hopes to get there in as little as three years.
| Round | Amount | Year | Selected Investors |
|---|---|---|---|
| Series A | $13.5M | 2018 | Sangel Capital, Rongsheng Investment, Highlight Capital |
| Series B | ~$14.3M | 2020 | Bayland Capital, Agaeti Venture Capital |
| Total (all rounds) | ~$41M | 2017-2020 | Highlight, Sangel, Bayland & others |
Shidong Jia and Pan Du establish the company in Hayward, California to advance non-invasive precision oncology.
Backing from Sangel Capital, Rongsheng Investment and Highlight Capital funds the liquid biopsy platform.
A further raise (~$14.3M) expands the assay portfolio and pushes toward regulatory milestones.
PredicineCARE receives Breakthrough status on August 23 - the regulatory turning point.
A companion-diagnostic partnership with J&J's Janssen, plus a distributable PredicineCARE NGS Kit for global labs.
Predicine submits the opening module of its FDA premarket approval application for the bladder cancer companion diagnostic.
Shidong Jia holds both an MD and a PhD, trained at Harbin Medical University and Peking Union Medical College, and did postdoctoral work at the Dana-Farber Cancer Institute and Harvard Medical School. Before Predicine he led oncology biomarker strategy and drug development at Genentech, where he is credited with identifying p110beta as a drug target for PTEN-deficient tumors - work that fed into the clinical development of p110beta inhibitors. He also served as editor-in-chief of the Journal of Circulating Biomarkers from 2014 to 2018.
The tidy way to describe his career is that he spent the first half of it building drugs and the second half building the tests that tell you which patient the drug is for. Co-founder Pan Du runs the technology side as CTO. Together they staffed the company with an unusual density of PhDs - roughly 35% - which is what you do when your product is fundamentally a biology problem wearing a business suit.
Biopharma companies use Predicine to develop companion diagnostics and to run biomarker analysis inside clinical trials - the Janssen bladder cancer collaboration is the clearest example. Oncologists and researchers use its CLIA/CAP labs to profile tumors non-invasively, to search for the mutations that make a targeted therapy work or fail, and to monitor whether a cancer is responding or returning. And through minimal residual disease testing, patients get a way to watch for recurrence that does not require another invasive procedure. The common thread: it turns questions that used to require surgery into questions you can answer with a tube of blood or a cup of urine.
Predicine's founder Shidong Jia has spoken about the company's liquid biopsy approach at the Precision Medicine World Conference (PMWC). Read the interview and find talks here: PMWC: Interview with Shidong Jia. For product walkthroughs and the latest talks, see the company's News & Events page and search “Predicine” on YouTube for conference presentations and assay overviews.
Predicine develops non-invasive liquid biopsy tests that read cell-free DNA and RNA from blood and urine to detect cancer mutations, monitor minimal residual disease, and match patients to targeted therapies.
It was founded in 2015 by Shidong Jia (Founder, Chairman & CEO), a former Genentech scientist with an MD and PhD, along with co-founder and CTO Pan Du.
PredicineCARE is Predicine's flagship NGS liquid biopsy assay profiling 152+ cancer genes from cell-free DNA. It holds FDA Breakthrough Device Designation and is in premarket approval as a companion diagnostic for bladder cancer.
Predicine has raised roughly $41M across multiple rounds, including a $13.5M Series A in 2018 and a Series B in 2020, from investors such as Highlight Capital, Sangel Capital, and Bayland Capital.
Predicine is headquartered in Hayward, California, with additional US offices in Houston and Schaumburg, Illinois, and an office in Shanghai, China.