An Indian-developed artificial intelligence (AI)-based diagnostic test is helping oncologists identify certain early-stage breast cancer patients who may be able to avoid chemotherapy, supporting more personalised treatment decisions.

Developed by OncoStem Diagnostics, the CanAssist Breast test assesses the risk of cancer recurrence in patients with hormone receptor-positive, HER2-negative early-stage breast cancer. According to the company’s founder, Dr. Manjiri Bakre, around 90–95% of early-stage breast cancer patients in India receive chemotherapy, partly because prognostic tests that help identify patients who may not benefit from it remain expensive or are not widely known.

The test analyses tumour tissue removed during surgery, measuring five protein biomarkers and combining the results with clinical parameters, including tumour size, tumour grade and lymph node status. An AI-based algorithm uses these inputs to generate a recurrence risk score on a scale of 1 to 100.

According to Dr. Bakre, a score below 15.5 indicates a low risk of recurrence within five years of diagnosis. Depending on the patient’s overall clinical profile, treatment may involve radiation therapy and hormone therapy without chemotherapy. The test is intended to support clinical decision-making rather than independently determine treatment.

CanAssist Breast is currently marketed by Zydus Lifesciences and is available to patients across India. Testing is conducted at OncoStem’s central laboratory in Bengaluru.

To improve access and reduce delays associated with transporting samples, OncoStem has also developed a kit-based version that would allow hospital pathology laboratories to conduct the test in-house. The kit is currently under review by the Central Drugs Standard Control Organisation (CDSCO). The company expects to receive its manufacturing licence by the end of 2026 or early 2027, Dr. Bakre said.

The development highlights the role of indigenous diagnostics in advancing precision oncology in India. By providing additional information about tumour biology and recurrence risk, such tests may help clinicians distinguish patients likely to benefit from chemotherapy from those for whom its additional benefit may be limited.

Wider awareness, affordability and access to validated prognostic testing will remain important to ensure that eligible patients can benefit from more individualised breast cancer treatment.