The company expects the decentralised model to at least double its annual testing volume to around 6,000 from the current run rate of about 3,000. More than 12,000 patients have used CAB during its roughly 10 years in the market, Bakre told Business Standard.

How does CanAssist Breast work?

CAB is intended for eligible patients with early-stage hormone-receptor-positive and HER2-negative breast cancer.

It measures five protein biomarkers in tumour tissue and combines them with tumour size, grade and lymph-node status. A machine-learning algorithm then classifies patients as having a low or high risk of distant recurrence.

A low-risk result can support an oncologist’s decision to use hormone therapy without chemotherapy, while high-risk patients may require chemotherapy or additional treatment.

OncoStem said around 70 per cent of patients tested through CAB had avoided chemotherapy.

The laboratory-based test presently costs around ₹60,000, substantially below imported genomic alternatives.

Oncotype DX costs around ₹2.5-3.6 lakh in India, according to prices listed by Indian healthcare providers and distributors. Bakre estimated that chemotherapy and management of its side effects could cost ₹3-5 lakh at a private hospital.

Hospitals will determine the final price of the kit-based test. While OncoStem expects to supply it at a lower per-test cost than the laboratory service, Bakre did not indicate how much of that reduction would reach patients.

India diagnoses around 200,000 new breast cancer patients annually, according to Bakre, of whom an estimated 50,000-60,000 could be eligible for such prognostic testing. However, only around 6,000-7,000 currently undergo CAB or an imported test, she estimated.

Peer-reviewed studies have supported CAB’s risk classification. A 2019 Cancer Medicine study of 857 patients reported five-year distant metastasis-free survival of 95 per cent in the low-risk group and 84 per cent among high-risk patients, while a Dutch TEAM cohort study validated its ability to predict recurrence risk over 10 years.

Why is OncoStem moving to a kit model?

“Today, patients across India and the globe send tumour samples to our laboratory in Bengaluru,” Bakre said. “This adds logistical delays, and international samples can get stuck at Customs. We are therefore packaging everything we do in the laboratory into a kit.”

Each kit will contain reagents for 25-50 tests and can be used in hospital pathology laboratories. It will not be a point-of-care test performed by patients.

The kit has received a test licence and completed analytical validation at an external institution approved by the Central Drugs Standard Control Organisation (CDSCO).

The regulator has now asked OncoStem to conduct a clinical performance evaluation comparing results from the hospital-based kit with its existing laboratory service.

The company has submitted the evaluation protocol and sample-size calculation and is awaiting permission to begin.

Bakre expects the kit could enter the market in six to eight months, subject to the evaluation, hospital ethics-committee approvals and final regulatory clearance.

OncoStem seeks reimbursement under public health schemes

OncoStem has approached the National Health Authority and state health-insurance schemes for reimbursement under government programmes, including Ayushman Bharat.

Bakre said covering the test could lower public expenditure by helping eligible low-risk patients avoid non-beneficial chemotherapy.

A Bengaluru-based contract manufacturer has already been selected. OncoStem’s existing laboratory test is marketed in India by Zydus Lifesciences, while the company will finalise a marketing partner for the kit closer to its launch.

OncoStem has raised around $9 million from Artiman Ventures and Sequoia Capital India.

Bakre said the company, which is operationally break-even, has a funding runway of one to two years and does not require additional capital for the initial production of the kits.

OncoStem also plans to seek CE-IVD certification for overseas kit sales. Its laboratory service currently receives samples from Sri Lanka, Bangladesh, the UAE and Turkey, while business from Nepal, Iran and Saudi Arabia remains intermittent.

Who could avoid chemotherapy?

• India diagnoses around 200,000 breast cancer patients annually
• 50,000–60,000 early-stage patients may be eligible for recurrence-risk testing
• CanAssist Breast classifies patients as having a low or high risk of cancer recurrence
• Low-risk patients may be treated with hormone therapy without chemotherapy
• Around 70% of CAB-tested patients avoided chemotherapy
• The test has reached 12,000+ patients over 10 years
• CAB costs around ₹60,000 per lab-based test
• Chemotherapy and management of its side effects can cost ₹3–5 lakh at a private hospital