Cancer
FDA approves Agilent test for ovarian cancer

Agilent has FDA approval for a test to identify ovarian cancer patients who may be eligible for immunotherapy.
Agilent’s PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic to help identify patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumours express PD-L1 and who may be eligible for treatment with KEYTRUDA, Merck’s anti-PD-1 therapy.
A companion diagnostic is a test used alongside a specific treatment to show whether a patient is suitable for that therapy. PD-L1 is a protein on some cancer cells that helps tumours evade the immune system.
These cancers affect the reproductive system and the lining of the abdominal cavity.
The test enables pathologists to assess PD-L1 expression at diagnosis to support treatment decisions in a disease where options remain limited for many.
This is the seventh FDA-approved companion diagnostic indication for PD-L1 IHC 22C3 pharmDx for use with KEYTRUDA.
Nina Green, vice president and general manager of Agilent’s clinical diagnostics division, said: “Delivering effective precision oncology requires close collaboration between diagnostics and therapeutics, and this FDA approval reflects Agilent’s long-standing industry partnership in companion diagnostics.
“We are proud to enable pathologists to identify patients with EOC who may benefit from immunotherapy.
“As the first immuno-oncology approval for this disease, this milestone underscores our commitment to advancing precision medicine and expanding access to innovative cancer treatments worldwide.”
PD-L1 expression with this test was evaluated in the KEYNOTE-B96 clinical trial supporting its use to identify patients who may benefit from KEYTRUDA.
In the US, ovarian cancer caused approximately 12,730 deaths in 2025 and the five-year survival rate was 51.6 per cent between 2015 and 2021.
In addition to these cancer types, the test is indicated in the US to help identify patients with non-small cell lung cancer, oesophageal squamous cell carcinoma, cervical cancer, head and neck squamous cell carcinoma, triple-negative breast cancer and gastric or gastro-oesophageal junction adenocarcinoma who may benefit from treatment with KEYTRUDA.
The test was developed by Agilent with Merck as a companion diagnostic for KEYTRUDA.
Diagnosis
Vaccine could prevent some people from developing ovarian cancer

A vaccine trial will test whether an mRNA jab can help stop precancerous cells developing into bowel and ovarian cancer in people with Lynch syndrome.
The first stage is due to launch this summer and will assess whether the jab can train the immune system to recognise and eliminate precancerous cells before cancer develops.
Around 175,000 people in England have Lynch syndrome, but only five per cent, or around 10,000 people, know they have it.
The inherited condition increases the risk of developing bowel cancer by 80 per cent and is linked to around 1,100 bowel cancer cases each year.
Lynch syndrome is also linked to a far higher risk of bowel, womb and ovarian cancer, alongside other types including stomach, pancreatic, kidney and skin cancer.
While the syndrome does not directly cause cancer, the genetic changes can lead to more abnormal cells developing, which then multiply and increase the risk of cancers such as bowel, prostate and endometrial cancer.
It is caused by an alteration in a mismatch repair gene. Carriers do not have any symptoms.
The new Intercept-Lynch trial is part of a scientific collaboration between the University of Oxford and Moderna, while Cancer Research UK has backed the vaccine’s development.
Once patients receive the new mRNA-4194 jab, experts will analyse their immune responses, assess the best dose and check whether the jab is safe.
The second phase of the study will include multiple centres across the UK, including Oxford, and is expected to begin in 2027.
The aim of the trial is to train the immune system with a vaccine to recognise abnormalities and stop them developing into cancer.
Professor David Church, Cancer Research UK senior cancer research fellow in the University of Oxford’s centre for human genetics and lead investigator of the trial, said: “People with Lynch syndrome are at risk of cancers over their entire lives.
“So, it’s very common, for instance, a woman to have a first cancer of her womb, and then some years later have a bowel cancer, or vice versa.
“The targets we’ve chosen for the vaccine were chosen based on their sharedness across multiple cancer types in Lynch syndrome, so we think they should provide broad protection, if the vaccine works.”
In people with Lynch syndrome, mutations can build up, making the cells containing them more likely to turn into cancerous cells.
However, those mutations can be made visible to the immune system and, with enough stimulation, the immune system can attack the abnormal cells and stop cancer from forming.
Professor Church said the mRNA jab acts as “an instruction manual” for the body to attack precancerous cells.
He added that, as with many vaccines, patients may need a booster jab at some stage.
On whether similar approaches could help prevent cancers not caused by Lynch syndrome, Professor Church said: “In terms of proof of principle that we can train the immune system to recognise these cancer-associated alterations and enhance the immune response against them to prevent these pre-cancers or prevent the progression of pre-cancer to cancer, that proof of principle should give us insights that are generalisable.”
David Berman, chief development officer at Moderna, said: “By applying mRNA technology earlier in the patient journey, we aim to harness the immune system when it can have the greatest impact.
“We are proud to bring this innovation to the UK, building on our long-standing collaboration with leading UK institutions to advance mRNA research and development.”
Diagnosis
Lymph nodes could reveal who’s most at risk of breast cancer spreading

Changes in lymph nodes may help show which breast cancer patients face higher or lower risk of the disease spreading, researchers have found.
The findings could support more tailored care, new treatments and help more people avoid unnecessary treatment.
Dr Simon Vincent is chief scientific officer at Breast Cancer Now, which funded the research:
He said: “These findings suggest that changes to the structure of the lymph nodes are more than just a consequence of the cancer. They can also play an active role in helping breast cancer progress.
“With one person tragically dying from breast cancer every 45 minutes in the UK, we urgently need research like this so that we can better understand who is most at risk of their cancer progressing and becoming incurable. Only then we can find ways to stop it.
“With a better understanding of how lymph nodes change as breast cancer spreads, we could find new targets for future treatments for types of breast cancer that are harder to treat.”
Lymph nodes, a key part of the immune system, help the body fight infections and cancer. In breast cancer, the lymph nodes in the armpit are often the first place the disease spreads to.
At the moment, everyone with invasive breast cancer has to undergo surgery to remove lymph nodes so doctors can check for cancer cells.
Invasive breast cancer means cancer that has spread beyond where it first developed in the breast into nearby tissue.
While this is effective, it can lead to long-term side effects such as swelling of the arm, known as lymphoedema, and may be unnecessary for some patients, particularly those with early-stage disease or those whose cancer responds well to treatment.
The study analysed 331 lymph node samples from people with different types of breast cancer and compared them with healthy lymph nodes from people free from the disease.
It found that breast cancer could change the structure of a network that supports the lymph nodes.
Crucially, some of these changes could occur before doctors were able to spot any cancer cells in the network.
Some changes were linked to a better chance of survival, while others were associated with a poorer prognosis.
Dr Amy Llewellyn and Dr Kalnisha Naidoo from King’s College London, together with professor Sophie Acton at University College London, compared the 331 samples with healthy lymph nodes in people free from the disease.
They looked at fibroblastic reticular cells, known as FRCs, a group of cells in lymph nodes that provide their structure, control fluid flow and activate different immune cells.
The study showed that the structure of this FRC network could change before the cancer had spread and differed depending on the type of breast cancer, any spread and whether someone had received chemotherapy.
Chemotherapy uses medicines to kill cancer cells or slow their growth.
The researchers said the findings could help doctors better understand who is most at risk of breast cancer spreading.
Dr Llewellyn said the first large-scale analysis of FRC in human lymph node tissue from breast cancer patients was addressing the “urgent need” for a better understanding of the area’s biology.
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