Veracyte’s genomic assay and GRAIL’s multi-cancer early detection (MCED) have demonstrated respective benefits in informing breast cancer treatment decision making and in detecting cancer earlier when used alongside standard of care (SoC) screening protocols.
Veracyte’s Prosigna assay analyses the activity of 50 specific genes (the PAM50 signature) within breast tumour tissue and generates a numerical risk of recurrence (ROR) score that predicts the likelihood of the cancer returning in a different part of the body within 10 years.
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In the OPTIMA Phase III trial, patients with oestrogen receptor-positive human epidermal growth factor receptor 2-negative (OR+/HER2-) early breast cancer (eBC) were tested with Prosigna. Patients with a high ROR score (above 60) received chemotherapy and hormone therapy, while those with a low score – less than or equal to 60 – were treated with hormone therapy alone.
In patients with low ROR scores, five years after treatment, 93.6% treated with hormone therapy alone were alive and recurrence-free, versus 94.8% in the control arm who received standard chemotherapy followed by endocrine therapy (CET).
The trial data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place in Chicago between 29 May and 2 June.
Robert Stein, professor of breast oncology at University College London’s (UCL) Cancer Institute and chief investigator on the OPTIMA trial, commented: “OPTIMA addresses a long-standing challenge in breast cancer care: identifying who truly benefits from chemotherapy and who does not. Our findings show that many patients can safely avoid chemotherapy without compromising their outcomes.”
Stein continued: “The trial has successfully used tumour biology to guide decisions rather than relying solely on traditional clinical features. For patients, this means many may be spared the physical and emotional burden of chemotherapy and its potential long-term side effects.“
OPTIMA’s research team said the results for the full trial population will be used to inform decision-making by healthcare bodies such as the National Institute for Health and Care Excellence (NICE), about wider UK National Health Service (NHS) access to Prosigna testing.
Galleri improves early cancer detection
Also presenting at ASCO 2026, GRAIL’s Galleri MCED test demonstrated benefit in increasing cancer detection when added to SoC screening programmes for breast cancer and others, including cervical cancer and lung cancer.
In an analysis of Grail’s 35,878-patient registrational PATHFINDER 2 study, adding Galleri to recommended screenings for breast, cervical, colorectal, and lung cancers (USPSTF A and B recommendations) led to a 6.5-fold increase in the number of cancers found by screening.
Using Galleri, 53% of the new cancers detected were stage I or II, and 71.3% of these have no USPSTF A and B recommended screening. Meanwhile, 70.9% of the new cancers detected by the MCED test were detected at stages I-III, when treatment with curative intent is more often possible, Grail stated.
Dr Karthik Giridhar, assistant professor of oncology at Mayo Clinic and a principal investigator on the PATHFINDER 2 study, commented: “PATHFINDER 2 provides important additional data on the performance and safety of MCED testing.
“MCED tests are not a replacement for existing screening, but they have the potential to complement current approaches by helping detect cancer signals across multiple cancer types, including some for which routine screening is not currently available.”
