OnCo
bottlenecksBottleneck

Inherited risk is mostly unidentified

Most people who carry a high-risk cancer gene do not know it until they or a relative gets cancer.

Pathogenic germline variants in BRCA1/2, the Lynch syndrome mismatch-repair genes, TP53, PALB2, CDH1 and others confer lifetime cancer risks of 40-80%, and effective risk reduction exists (risk-reducing surgery, intensified surveillance, aspirin, PARP inhibitors when cancer occurs). Yet most carriers are identified only after a cancer diagnosis, and often not even then: fewer than a fifth of US women with a history of breast or ovarian cancer who met testing criteria had been tested. Cascade testing of relatives, the cheapest way to find healthy carriers, reaches a minority of eligible family members. Germline testing is also inequitable, with reference databases dominated by European ancestry, so variants of uncertain significance are more common in other populations. Polygenic risk scores could stratify screening for common cancers but are not yet implemented or validated across ancestries.

majorprevention detection20 ideas to fix it
How big the problem is
Fewer than 20%
US women with a history of breast or ovarian cancer meeting NCCN criteria who had undergone genetic testing (2005-2015 NHIS)
About 1 in 279
Estimated population prevalence of Lynch syndrome
81%
Share of participants in genome-wide association studies of European ancestry (2016)
Root causes
  • Testing is triggered by family history, which is often unknown, incomplete or not asked about.
  • Cascade testing depends on the index patient informing relatives, with no systematic follow-through.
  • Genetic counselling capacity is limited and testing criteria are complex.
  • Reference databases under-represent non-European ancestries, producing more uncertain variants.
  • Population screening for germline variants has been considered too costly, although sequencing costs have fallen sharply.
What is already being tried
  • The NHS Jewish BRCA Testing Programme offers population-based BRCA testing to people with Jewish ancestry in England.
  • Universal tumour screening for Lynch syndrome in all colorectal and endometrial cancers is guideline-recommended and being audited in the UK and US.
  • NCCN and ESMO guidelines have broadened germline testing criteria, including all patients with pancreatic, ovarian and metastatic prostate cancer.
  • The WISDOM trial tests risk-based breast screening incorporating polygenic risk scores against annual mammography.
  • ClinVar and ENIGMA/InSiGHT expert panels curate variant classification and reduce uncertain variants.
  • Mainstreaming programmes let oncologists order germline tests directly, bypassing the counselling bottleneck.
What breaking it looks like
A majority of carriers of high-penetrance variants are identified before a cancer diagnosis, cascade testing reaches most first-degree relatives, and variant classification and polygenic risk perform equally well across ancestries.

Ideas to fix it

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being tested at scaleresearchlarge cost
A bone drug to prevent breast cancer in BRCA1 carriers

BRCA1 breast cancers seem to grow from cells driven by the RANK signal. Denosumab blocks it and is already used for bone. A trial is testing whether it prevents these cancers.

early clinicalengineeringsmall cost
A chatbot for pre-test genetic counselling so counsellors see only who needs them

There are far too few genetic counsellors. A validated chatbot can do the standard pre-test education, leaving people with complex needs for humans.

early clinicalresearchlarge cost
A frameshift neoantigen vaccine for Lynch syndrome carriers as the first preventive cancer vaccine approval

People with Lynch syndrome have a very high lifetime cancer risk from a predictable set of mutations. Vaccinate them against those shared mutations before cancer appears.

early clinicalindustrylarge cost
A randomised trial of a shared-antigen vaccine to prevent Lynch syndrome cancers

Lynch syndrome tumours share predictable mutations the immune system can target. A vaccine in early trials could be tested to see if it prevents polyps and cancers in carriers.

being tested at scaleclinicsmall cost
Automatic germline testing for every cancer type where it changes care

Anyone with ovarian, pancreatic, metastatic prostate or mismatch-repair-deficient cancer should be tested for inherited mutations, but many are not. Make it an automatic, opt-out lab step.

speculativepolicysmall cost
Ban life and disability insurers from using genetic results

Fear of losing insurance stops many people having genetic tests. Extending non-discrimination law to life and disability cover, as Canada has, would remove that fear.

early clinicalresearchlarge cost
Build polygenic scores that work in every ancestry before deploying any

Genetic risk scores were built mostly on Europeans and work worse in others. Funding non-European cohorts and setting a portability standard would prevent screening that widens inequality.

speculativeresearchlarge cost
Engineered immune surveillance: long-lived programmed immune cells that patrol for early cancer

For people at very high cancer risk, install a small population of engineered immune cells that live for years and destroy cells showing early cancer signals before a tumour forms.

early clinicalengineeringsmall cost
Family history collected by app and matched to testing criteria automatically

Doctors rarely take a full family history. An app that gathers it from the patient and checks it against testing guidelines would find many people who qualify.

being tested at scaleclinicsmall cost
Get every Lynch syndrome carrier onto the right dose of aspirin

Aspirin roughly halves bowel cancer in Lynch syndrome, and a dose trial is defining how little is needed. Most carriers are still not prescribed it; the task is to fix prescribing.

early clinicalclinicmedium cost
Go back to families of women who died of ovarian cancer and offer BRCA testing

Many women who died of ovarian cancer were never tested for BRCA. Testing their stored tumour samples and contacting their relatives would find carriers before they get cancer.

early clinicalclinicsmall cost
Let clinics contact relatives directly when a cancer gene is found

When someone tests positive for a BRCA or Lynch mutation, relatives are told only if the patient passes the message on. Most do not. Letting clinics contact relatives directly, with consent, could double testing.

being tested at scalepolicylarge cost
Offer everyone at 30 a test for the cancer genes that matter

Most people with BRCA or Lynch mutations do not know until they get cancer. Testing everyone once for a short list of high-impact genes would find them in time to prevent it.

being tested at scaleclinicsmall cost
Oncology teams order germline tests; tele-genetic counsellors handle the results

There are too few genetic counsellors to see every patient who should have an inherited-risk test. Let the cancer team order the test with a short consent script, and use video counsellors for those with results that matter.

being tested at scalepolicylarge cost
Population germline screening for hereditary cancer genes with cascade testing

Most people carrying a high-risk cancer gene do not know it until someone in the family gets cancer. Offer testing to all adults so carriers can be protected before that happens.

speculativepolicymedium cost
Store adult-onset cancer gene results from newborn genomes and disclose at 18

Newborn sequencing programmes exclude adult cancer genes because babies cannot consent. Storing those results and offering them at 18 would preserve choice and give a lifetime of prevention.

preclinical evidencephilanthropymedium cost
Test every possible mutation in every cancer gene so no result is 'uncertain'

Many people get a genetic result of uncertain significance, which cannot be acted on. Lab methods now let us test every possible variant in a gene in advance.

being tested at scalepolicylarge cost
Universal tumour and germline sequencing at diagnosis feeding a shared learning system

Sequence every cancer at diagnosis, along with the patient's inherited genes, and pool the results with treatments and outcomes so every patient teaches the system how to treat the next.

early clinicalpolicylarge cost
Use a polygenic risk score to set when screening starts

Common gene variants shift a person's cancer risk several-fold. A one-time genetic score could tell each person when to start breast, bowel or prostate screening.

early clinicalresearchmedium cost
Whole-body MRI plus blood DNA surveillance for people with Li-Fraumeni syndrome

People with an inherited TP53 mutation face a near-certain lifetime cancer risk. Yearly whole-body MRI catches cancers early; adding blood DNA tests may catch them earlier still.

Key papers

6top
rctNew England Journal of Medicine 2021changed practice
OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer

Everyone with HER2-negative early breast cancer that meets high-risk criteria should be offered germline BRCA testing, because a positive result now changes treatment: a year of olaparib after chemotherapy reduces relapse and death. It does not apply to low-risk tumours, HER2-positive disease, or somatic-only BRCA mutations.

rctThe Lancet 2020changed practice
CAPP2: two years of aspirin cuts bowel cancer in Lynch syndrome by more than a third over 10 years

People with Lynch syndrome should be offered daily aspirin, which roughly halves bowel cancer risk with a delayed and durable effect. Whether a lower dose (as tested in CAPP3) is as effective, and whether the finding extends to the general population, are separate questions.

translationalClinical Cancer Research 2020
First trial of a vaccine against the shared neoantigens of mismatch-repair-deficient cancers

Because Lynch syndrome tumours make the same abnormal proteins in almost every patient, a single vaccine could in principle be given to carriers before cancer develops. This small trial showed the concept is safe and immunogenic; whether it prevents cancer requires the randomised trials now being planned.

rctNew England Journal of Medicine 2018changed practice
SOLO-1: two years of olaparib maintenance after first-line chemotherapy for BRCA-mutated ovarian cancer

Every woman diagnosed with advanced high-grade ovarian cancer should be tested for BRCA mutations at diagnosis, because those who carry one should receive two years of olaparib after chemotherapy, which greatly extends the time in remission and improves long-term survival. The plateau in the survival curves suggests some patients are cured by this approach. Toxicity is mostly anaemia, fatigue and nausea, and the two-year limit appears sufficient.

rctLancet Oncology 2015changed practice
IBIS-I: five years of tamoxifen keeps preventing breast cancer for at least 20 years

For women at raised risk, a 5-year course of tamoxifen offers long-lasting protection against the commonest kind of breast cancer. Uptake is low because of side effects and fear of rare serious harms; low-dose tamoxifen (TAM-01) is now being tested to improve the balance. It has not been shown to save lives.

observationalJAMA 2010changed practice
PROSE consortium: preventive surgery lowers cancer and death in BRCA1 and BRCA2 carriers

For women who carry a BRCA mutation, preventive removal of the ovaries and tubes saves lives, and preventive mastectomy almost eliminates breast cancer. These are the strongest prevention effects in oncology, which is why finding carriers before they develop cancer matters so much.

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A bone drug to prevent breast cancer in BRCA1 carriersA chatbot for pre-test genetic counselling so counsellors see only who needs themA frameshift neoantigen vaccine for Lynch syndrome carriers as the first preventive cancer vaccine approvalA randomised trial of a shared-antigen vaccine to prevent Lynch syndrome cancersAutomatic germline testing for every cancer type where it changes careBan life and disability insurers from using genetic resultsBuild polygenic scores that work in every ancestry before deploying anyCancer interception vaccines for high-risk carriersEngineered immune surveillance: long-lived programmed immune cells that patrol for early cancerFamily history collected by app and matched to testing criteria automaticallyGet every Lynch syndrome carrier onto the right dose of aspirinGo back to families of women who died of ovarian cancer and offer BRCA testingLet clinics contact relatives directly when a cancer gene is foundOffer everyone at 30 a test for the cancer genes that matterOncology teams order germline tests; tele-genetic counsellors handle the resultsPopulation germline screening for hereditary cancer genes with cascade testingStore adult-onset cancer gene results from newborn genomes and disclose at 18Test every possible mutation in every cancer gene so no result is 'uncertain'Universal tumour and germline sequencing at diagnosis feeding a shared learning systemUse a polygenic risk score to set when screening startsWhole-body MRI plus blood DNA surveillance for people with Li-Fraumeni syndrome

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