More molecules.

Cancer drugs now aim at mutations

The FDA approved daraxonrasib, the first RAS drug for pancreatic cancer. RAS mutations drive about 9 in 10 of these cancers.

The next drugs aim at single mutations. To choose them, and to see if they work, doctors read the tumour's DNA. Again and again.

RASolute 302 (ASCO 2026, NEJM); FDA approval 26 Aug 2026. KRAS mutated in ~93% of pancreatic adenocarcinomas (TCGA 2017).

Tumours shed DNA into the blood

Dying tumour cells release short fragments of DNA. They end up in the blood, and from there in the urine.

Catch those fragments and you can read the tumour without cutting into it. That's a liquid biopsy.

Liquid biopsy is already in the clinic

• Choose the drug. Guardant360 CDx reads the tumour's mutations from blood, FDA-approved 2020.
• Watch for relapse. Natera's Signatera tracks the patient's own tumour mutations after surgery.
• Find it early. Guardant Shield (2024) and Freenome SimpleScreen (July 2026) screen for bowel cancer from blood.

Q3 2026 vs Q3 2025, company reports: Natera, Guardant (incl. Shield), GRAIL, Tempus.

The race to one in a million

Every year the best teams in diagnostics see smaller traces: error-corrected reads, methylation, whole genomes, thousands of mutations tracked at once.

Brilliant chemistry. All of it happens after the blood is drawn.

Signatera (Natera whitepaper); NeXT Personal (Oncotarget 2024); Shield (FDA SSED P230009); GRAIL (PLoS One 2023); 2026 figures are company claims.

At one in a million, the expected number of tumour copies of any one mutation in that tube is 0.006. Usually zero.

“If no physical fragment that supports a targeted [mutation] is present in the sample, even ideal ultra-deep targeted sequencing will fail to discover a signal.”Zviran et al., Nature Medicine 2020 (median 6,000 copies in 194 patients)

The record numbers need the tumour first

The best relapse tests sequence the patient's tumour, then track up to 5,000 of its mutations across the copies in the tube. Lots of chances from few copies.

Screening has no tumour to learn from. Screening tests stop at about 1 in 2,000 to 1 in 600.

To find a cancer nobody knows about yet, you need more molecules.

What if we just had more material?

Urine carries DNA from the blood too

The kidneys pass DNA fragments from the blood into the urine. You can collect a whole cup at home, every year, with no needle.

HFX, our device, concentrates the DNA from 100–500 mL into one small pellet: 10–30× what a urine kit gets.

300 mL is device capacity, scaled from our 100 mL data: 250–1,000 ng cfDNA per 100 mL, 3.3 pg per copy, vs a median 6,000 copies per blood sample.

Now there's something to find

At one tumour copy in 100,000, a blood tube expects 0.06 tumour copies. The cup expects 2 to 9, if urine carries the same tumour share as blood. For pancreatic cancer, that's the first thing we measure.

More copies, more chance one is there

Chance that at least one copy of a given tumour mutation is in the sample

At 1 in 100,000: blood 6%, HFX 89% to ~100%. At 1 in a million: 0.6% vs 20–59%.

If urine carries the same tumour share as blood. For pancreatic cancer nobody knows yet.

Pancreatic cancer

Half are found after the cancer has spread. No screening test is recommended for the public. 52,740 Americans die of it every year.

The new RAS drugs are moving to right after surgery. That only helps people whose cancer is found in time. First pancreatic data: 2027.

Five-year survival localised 44%, distant 3% (SEER). US deaths 2026: ACS.

Big labs buy their way in

• Veracyte bought Convergent Sep 2026 · urine tumour DNA
• Tempus is buying Personalis Jul 2026 · ~$1.5B
• Abbott bought Exact Sciences Mar 2026 · ~$23B
• Roche bought SAGA FoundationOne MRD, May 2026
• Quest bought Haystack Jun 2023
• Labcorp bought PGDx Feb 2022

HFX sits before the chemistry: any of these assays could use the extra copies.

Team

Advisors: Prof. Jack Schalken (experimental urology, Radboudumc), Jan Groen (raised $150M+, sold a urine diagnostics company), Joris Schuurmans (CEO Delta Life Sciences).