Clinical-stage genomic diagnostics · Nevada, USA
Most cancers have no screening test at all.
Screening today is built organ by organ a mammogram for breast, a colonoscopy for colon, a scan for the lungs. Everything else is usually found once someone already feels ill. EarlySignal is developing a blood test intended to look for more than fifty cancers at once, from a single draw.
Background methylation
Coherent cancer signal
Illustrative — not measured data
The gap
Five cancers are screened for. The rest are not.
United States guidelines recommend population screening for a short list of cancers. Several of the most lethal — pancreatic, ovarian, oesophageal, liver — have no recommended screening pathway for people at average risk, which is one reason so many are found late.
Recommended population screening
Single-organ tests, one at a time
Breast
Mammography
Colon and rectum
Colonoscopy / stool
Cervix
Cytology / HPV
Prostate
PSA, shared decision
Lung
Low-dose CT, high risk
No recommended screening pathway
Usually found once symptoms appear
Pancreas
Ovary
Oesophagus
Liver and bile duct
Stomach, kidney, brain, blood … and most others
Please read this alongside the list above
A blood test that looks at many cancers at once is intended to add to organ-specific screening, not replace it. Whether multi-cancer early detection improves outcomes for patients is still an open scientific question, and we set out the current state of that evidence plainly on The Test.
What we are building
Three pieces have to come together.
A test
Targeted sequencing of DNA methylation patterns in cell-free DNA, read by a machine-learning classifier that is designed to flag a cancer signal and predict where in the body it came from.
A laboratory
A high-complexity laboratory certified under CLIA, acquired or built, where the test can be validated and run. This is the step that turns a method into something a clinician can order.
Evidence
Analytical and clinical validation, publication with academic partners, and a pivotal study designed with the FDA. Nothing else counts until this exists.
A second diagnostics business
CATS Tonometer, LLC
We have signed a definitive agreement to acquire CATS Tonometer, LLC of Tucson, Arizona — an operating ophthalmic device company whose FDA-cleared prism is used to measure eye pressure in the diagnosis and management of glaucoma.
Business
Ophthalmic diagnostic devices
Product
CATS® Tonometer Prism
Location
Tucson, Arizona
Structure
100% of membership interests
Status
Definitive agreement signed; closing subject to conditions
Where we are
Early, and saying so.
EarlySignal is a development-stage company. We have no revenue, our test has not been validated in a pivotal study, and no multi-cancer early detection test has yet been approved by the FDA or recommended by United States practice guidelines. We would rather be direct about that than describe a product we do not yet have.