In this conversation, Dr Manjiri Bakre, Founder and CEO, OncoStem Diagnostics, discusses how India’s breast cancer landscape is changing, with younger women presenting with aggressive disease even as early-stage detection improves. She explains why biology-based prognostic testing can safely spare up to 70% of eligible early breast cancer patients from unnecessary chemotherapy, and how this transforms both quality of life and family finances. Drawing on real patient journeys and a decade of work validating the India-developed CanAssist Breast test globally, Dr Bakre outlines the policy and reimbursement gaps that still limit access to advanced diagnostics. She also sets out what government hospitals, cancer centres and insurers must do to integrate tumour biology, AI-driven tools and Made‑in‑India tests into routine care, so that personalised breast cancer treatment becomes the norm rather than the exception.
1. In your recent clinical experience, how has the profile of an Indian breast cancer patient changed in terms of age, stage at diagnosis, and survival, and what worries you most about these trends?
In India, breast cancer tends to present at a younger age compared to Western populations. Most Indian patients are premenopausal or perimenopausal, with an average age of around 48, whereas in the West, it is more common among postmenopausal women above 55. Indian patients also have a higher incidence of triple-negative breast cancer, which is typically more aggressive.
At the same time, there has been a noticeable increase in early-stage detection compared to 15 years ago. This is an encouraging trend, even as the overall number of diagnosed cases continues to rise each year.
Cancer in younger women can be slightly more aggressive. In addition, due to a lack of awareness, taboos, and limited use of mammography, patients are often diagnosed when they feel a lump. As a result, tumours are typically larger, >5 cm, and may involve lymph nodes at diagnosis. This is worrying as cure rates are best when cancer is diagnosed at the earliest stage. Also, cancer getting diagnosed at an earlier age is very worrying as it interferes with childbearing, fertility, and these young women have their entire life ahead and the side effects of treatment can bring quality of life down significantly.
2. For an early-stage patient sitting across from you, how do you explain that chemotherapy may not always be necessary, and that tumour-biology-based prognostic testing can guide that decision?
Even when two women are of the same age, say 45, and have tumours of the same size, their outcomes can be very different. One may experience a recurrence, while the other may not. The difference lies in tumour biology.
In many cases, both patients are treated similarly based on standard clinical parameters. However, if one patient has a low-risk tumour biology, she may not have a recurrence despite receiving the same treatment. On the other hand, a patient with more aggressive tumour biology may experience recurrence, and in such cases, chemotherapy would have been necessary.
So, despite similarities in age, tumour size, and treatment, it is the underlying tumour biology that determines outcomes. Prognostic tests help assess this biology, allowing us to distinguish between less aggressive and highly aggressive tumours and tailor treatment accordingly.
One of the things we regularly hear from our partner oncologists is that evidence-based medicine plays an important role in patient counselling. When doctors present the data about how worldwide studies have shown that chemotherapy does not benefit every patient and prognostic tests are widely used to understand who will benefit from taking chemotherapy in the West, share patient stories and let the evidence speak, patients and their families are far more open to accepting the treatment plan.
Knowing that a safe, chemotherapy-free treatment plan may be possible is in itself a huge reassurance and relief for patients. When a patient first walks in, their biggest fear is often chemotherapy. They are worried about the side effects and the physical toll of it on the patient. This is where prognostic testing becomes very helpful. If the tumour has a low risk of recurring, chemotherapy may not add significant benefit. We show patients that the treatment plan is based on the biology of their tumour and on evidence from clinical studies. When patients understand that they can avoid chemotherapy without compromising their chances of cure, it becomes much easier for them to accept the recommendation.
3. Could you share one or two real patient stories where a prognostic test clearly helped avoid chemotherapy and changed the woman’s quality of life and family finances?
Testimonial 1: Safinaz Begum
During my radiation therapy, I was worried about whether my body would return to normal and what treatment would come next. I had seen many chemotherapy patients in the hospital who were weak and had lost their hair, and I feared I would have to go through the same.
When I met the medical oncologist, he reviewed my reports and recommended the CanAssist Breast test to assess my risk of recurrence. We were not aware of this test, but we went ahead with it.
When the results came, the doctor told me that I had only a 6% chance of recurrence and that I would not need chemotherapy. Instead, I could continue with hormone therapy. I was hesitant at first, but he reassured me that chemotherapy was not necessary in my case.
This test made a big difference in my life. It helped me avoid the fear and side effects I had associated with chemotherapy, and today I can live a normal, active, and healthy life.
Testimonial 2: Tulika Sarkar
My name is Tulika Sarkar, and I am 52 years old. I was diagnosed with breast cancer in the last week of January, after which I consulted my doctor.
Following my surgery, he recommended that I take the CanAssist Breast test to better understand my risk of recurrence. The results showed that I was at low risk, and as a result, I did not need to undergo chemotherapy.
This has brought me a great sense of relief, both mentally and financially.
4. From a clinician’s standpoint, how common is overtreatment with chemotherapy in early-stage breast cancer in India, and what evidence tells you this is happening at scale?
Traditionally in India, about 90–95% of patients with hormone receptor–positive, HER2-negative early breast cancer would receive chemotherapy based on clinical parameters such as age, tumour size, grade, and lymph node status.
However, when tumour biology is assessed using prognostic tests, around 70% of these patients are found to be at low risk of recurrence and may not require chemotherapy. This indicates that a large proportion of patients were receiving chemotherapy unnecessarily.
Additionally, when I was starting with OncoStem, I had the opportunity to speak with many oncologists about whether they were using prognostic tests. At that time, only Western tests were available. Most of them acknowledged the need for prognostication, especially given the risk of overtreatment with chemotherapy. However, they also pointed out that these tests were not easily accessible. They were not well validated on our patients in India, were expensive, required sending tumour samples overseas, and took a long time to deliver results. As a result, they were not being used in routine clinical practice.
In the absence of a reliable way to assess recurrence risk, the default approach has been to prescribe chemotherapy to patients.
5. Looking at India’s current cancer policies and schemes, which specific measures actually support access to advanced diagnostics, and where do you see the most worrying gaps for patients?
Most schemes cover the cost of the treatment very well, but not always the diagnostics/investigations done in OPD. This is another reason why patients do not opt for prognostic tests. When a tumour is removed from the body, it is part of a surgical procedure. Technically, it should be eligible for reimbursement. These tests should be covered because they help patients receive only the treatment they truly need, and in turn help insurers avoid unnecessary treatment costs.
Prognostic tests are not done for the sake of testing. They are used to understand tumour biology to assess the risk of cancer recurrence and, based on that, plan the most appropriate course of treatment.
This is how it works in the Western world-prognostic tests such as OncoType DX are covered by most (government and private) health insurance providers in the US. This approach also helps reduce the overall cost of chemotherapy for payers.
Currently, reimbursement for advanced diagnostics such as prognostic tests is not uniformly available. Some patients under CGHS, ECHS, and certain private insurance schemes have received reimbursement, but this is not consistent.
There is an opportunity to integrate such tests into national programmes like Ayushman Bharat so that access can be expanded. At present, the lack of structured reimbursement remains a key gap.
6. You have worked with both public schemes and private insurers to secure reimbursement for your test. What finally convinced payers that investing in prognostic tools can reduce overall treatment costs and hospital visits?
It is still a work in progress. Insurance companies want to see strong published data on how effective the test is, including validation studies and real-world evidence. When they have access to this data, it helps build confidence. At the same time, there needs to be a dialogue between insurers and doctors to understand whether these tests are being used in clinical practice and how useful they are. If doctors find value in them, it further strengthens confidence among insurers.
The key factor is the overall cost of treatment. Chemotherapy and management of its side effects involve significant financial strain on the patient/ payers.
If prognostic tests can identify patients who do not need chemotherapy, these costs can be avoided. Since about 70% of patients can avoid chemotherapy based on test results, covering such tests can result in significant cost savings for insurers. Insurance companies rely on data and we have a lot of published data which has helped to convince doctors and insurance companies to adopt the CanAssist Breast or cover its cost, respectively.
7. Beyond reimbursement, what changes are needed in government hospitals and cancer centres so that women outside big metros can also access biology-based risk tests as part of routine care?
The first step towards enabling access is increasing awareness of prognostic tests among patients, their families, and oncologists in Tier 2 and Tier 3 cities. When doctors are aware that cost-effective options are available, and that these tests can help reduce unnecessary treatment and associated costs, it becomes easier to integrate them into clinical practice and improve patient access. Also, when patients are aware of such tools, they can confidently ask doctors if they are eligible for the prognostic test. Another change needed is if the patient can be counselled before surgery by doctors about such tests and if they agree to do it pay for the prognostic test at the hospital, so it becomes easier and streamlined.
8. Your flagship test was developed on Indian tumour samples and then validated internationally and against established Western assays. How has this journey shaped your view of India’s ability to build globally credible oncology tools?
This journey has given the entire team at OncoStem a great deal of confidence. We developed the test using Indian tumour samples, and then saw it validated strongly in global studies, not only for 5-year predictions/clinical outcomes but also for 10-year patient outcomes as well.
Every time we validate the test in a new country or as part of a clinical trial, it further reinforces our confidence. It has also helped build trust within the team and the broader ecosystem, including clinicians and payers. It shows that something developed in India can work effectively across global populations.
The reason for this lies in the sound science backing the test. The biomarkers we selected are fundamental to how breast cancer spreads. These are universal biological mechanisms, so whether the patient is in India or elsewhere, the test remains relevant and accurate.
Early-stage breast cancer is known to recur over a period of 5 to 10 years. In Western countries, long-term clinical trials with extended follow-up periods have been conducted systematically. Access to such well-documented clinical trial samples has enabled us to validate our test for predicting recurrence even up to 10 to 15 years.
This has further strengthened confidence in the test, which is why we continue to validate it across different countries even today.
9. Doctors in Tier 2 and Tier 3 cities often work with limited resources. What practical hurdles do they face in using prognostic tests, and what are you doing to narrow this urban–rural gap?
One of the main hurdles is the lack of awareness among doctors about the availability of cost-effective, India-developed prognostic tests. Another challenge is that these tests are not yet fully integrated into standard treatment workflows. They are often considered only after surgery and hormone receptor testing, which can delay decision-making.
In addition, the lack of standardised reimbursement makes it harder for doctors to recommend these tests in routine practice.
To address this, we are focusing on increasing awareness and improving accessibility. One key step is the development of a kit-based version of CanAssist-Breast that can be used directly within hospitals. This will help integrate the test into routine workflows and make it more accessible across centres.
Another important aspect is inclusion in treatment guidelines. Doctors often tell us that when a test is part of official guidelines, they can recommend it to patients with greater confidence. It is no longer seen as an optional add-on, but as a necessary step in planning treatment. Since guidelines are followed across the country, this can also help bridge the urban-rural gap.
Delays also occur when tumour samples need to be transported from smaller towns to central labs. To solve this, we are working on making CanAssist-Breast available as a kit that can be used in hospitals with the required Roche platform, which is already present in many centres. This means that even in smaller cities or interior regions, tests can be conducted locally without the need to send samples to our lab in Bengaluru.
This approach will reduce turnaround time, improve access, and ensure that patients receive timely reports regardless of where they are diagnosed.
10. Since your platform uses an AI-driven algorithm on top of standard pathology, what kind of transparency, validation, and regulatory oversight do you believe is essential for AI in oncology decision-making?
The most important point, which is often misunderstood, is how the AI itself is built and used. While there is a lot of hype today around AI systems that keep learning, that is not how our platform works.
Our algorithm is a locked model. It was trained on data over multiple rounds, a process that took nearly two years. Once the learning phase was complete, the model was locked. It does not continue to learn or change with new data. This ensures consistency and reliability in outcomes.
All the biomarkers we use, as well as the development of the algorithm, are published. The biomarker combination has been scientifically developed, published, and patented. This level of transparency allows clinicians and researchers to clearly understand how the test works.
Validation and regulatory oversight are equally critical. We operate under globally recognised standards such as ISO 13485, along with NABL and the US College of American Pathologists. These bodies regularly audit our processes, systems, and data logs to ensure quality and compliance.
In oncology decision-making, an AI model mustn’t produce variable results because it is still learning. That is what we have ensured. With a locked and validated model, there is consistency in results and no ambiguity in the outcomes generated by the test.
11. If India were to fully integrate tumour-biology and prognostic testing into standard early breast cancer pathways, how do you think the typical journey of a newly diagnosed woman would look 10 years from now?
This is how I see it evolving over the next ten years.
We will have much stronger screening built into routine care, with better insurance coverage. A woman may either feel a lump herself or have it detected during a regular screening, such as a mammography or MRI. If a lesion is identified, a biopsy will be done at the hospital to determine whether it is benign or malignant.
If it is malignant, key biomarkers such as ER, PR, and HER2 will be tested immediately on the biopsy sample. At this stage, before surgery, there should be a structured patient counselling session. The patient should be clearly informed about the diagnosis, the biomarker status, and the next steps.
If the tumour is early-stage, for example, hormone receptor positive and HER2 negative, prognostic testing can be planned upfront. With the patient’s consent, surgery can be performed to remove the tumour, and the sample can be sent for prognostic testing while the patient is recovering.
By the time the patient returns for a follow-up, typically in two to three weeks, the prognostic test results should be ready. This allows the doctor and patient to have a clear, informed discussion on the next steps in treatment.
This approach removes delays. Today, testing often happens after recovery, which adds time depending on logistics and location. In the future, these steps will be streamlined so that treatment decisions can be made immediately after recovery, based on a complete understanding of tumour biology.
12. Finally, if you had to outline three concrete steps that the government, hospitals, and insurers must take to move from one-size-fits-all chemotherapy to genuinely personalised cancer care, what would those be?
- First, inclusion in treatment guidelines will help build confidence among doctors and support wider adoption. Regulators, clinicians, and patients should all start believing in well-validated, accredited, patented and published Made in India products and support them.
- Second, prognostic tests need to be integrated into reimbursement frameworks so that patients can access them without financial barriers.
- Third, hospitals should incorporate these tests into standard treatment workflows to enable timely decision-making.
Another important aspect is mindset. We need to start by believing in Made in India solutions. This is not just about one test, but about the broader ability of India to build high-quality prognostic tests, diagnostics, and drugs. Unless that belief comes first, it becomes difficult to move forward on adoption, guidelines, and implementation.
Once that foundation is in place, the next step is inclusion in treatment guidelines. When tests are part of standard guidelines, adoption becomes more consistent and doctors are more confident in prescribing them.
The next step is insurance coverage. Whether through public or private schemes, these tests need to be covered so that patients are not burdened with out-of-pocket costs. This removes a major barrier to adoption.
Finally, these tests need to be integrated into hospital workflows. That is when structured counselling and timely decision-making become part of routine care. If hospitals can incorporate these tests into their existing pathology systems, especially through kit-based formats, it becomes easier to manage and scale.
