Startup Circle: How is OncoStem transforming breast cancer treatment in India with CanAssist?

Breast cancer is the most common type of cancer in India. About 150,000 women are diagnosed with breast cancer every year in the country, of which 50 per cent fall under Stage I and II. However, due to the lack of recurrence tests, most of them have to go through the painful and toxic process of chemotherapy, even if there is little need. This painful procedure can be avoided if needed using Oncostem technology.

OncoStem was founded by Dr Manjiri Bakre, a PhD in Cell Biology from the Indian Institute of Science (IISc). The company uses machine learning to solve the problem of over-treatment of breast cancer through its test CanAssist Breast that predicts the risk of recurrence. To know more about the technology, and the unique way in which they are transforming the healthcare sector, CIOL had a conversation with the CEO and Founder, Manjiri Bakre.

Excerpts of the interview with Dr Manjiri Bakre, CEO and Founder, OncoStem Diagnostics is given below.

How did you come up with the idea?

OncoStem started in 2011. But the seed was sown when I was pursuing my PhD at Indian Institute of Science. A friend of mine at IISc was diagnosed with breast cancer. She detected cancer when it was small/early stage and underwent surgery soon after. When she was pursuing her post-doctoral fellowship, her cancer recurred in her body in 2-3 sites. Her cancer was aggressive and despite all treatment options, we lost her within 2-3 years of diagnosis. This made me think that we need to be more aware of the course of cancer. We should know about the aggressiveness of cancer whether it is a ‘small or big’ tumour so that the patient can plan their treatment and life accordingly.

I noticed that other companies in the West have developed tests that can predict the recurrence of cancer. However, these tests are out of reach for our patients here because of the cost and also because of the different biology of the disease in Indian patients. The Western tests were validated on patients from the west and the biology of the patients in the west is different from that of patients in the east. This is when I decided to develop a  test based on Indian patients that will help in beneficial treatment planning for our patients. This was the genesis for OncoStem Diagnostics.

How did you survey the market? How did you find that the product works? Any samples, testing etc?

I spoke to various oncologists across India to assess the need for such a product. The doctors were very clear that there was a gap in the market and an affordable solution was greatly needed.  I started approaching hospitals and biostatisticians to get working on the development of the test. We approached 60 hospitals and ultimately worked with 10 hospitals in India to make CanAssist Breast a reality.

We analysed breast tumour tissues for multiple biomarkers/proteins reflective of aggressive biology of the tumour. Using this data, we developed a support vector machine (SVM) based statistical model. This assigns a ‘risk score’ based on the key selected five biomarkers and clinicopathological information for each patient. The ‘risk score’ is indicative of the risk of recurrence. This ‘risk score’ categorizes patients based on the ‘risk of cancer recurrence’ clearly as either ‘low or high’.

Thus, by analysing patient’s tumour CanAssist Breast ‘identifies’ breast cancer patients who will have the minimal benefit (Low-risk) or who will benefit the most (high risk) by adding chemotherapy to their treatment. OncoStem’s “Made in India” test is most suitable for Indian Patients.

Oncostem has obtained various international quality-related and regulatory approvals (CAP, NABL, CE-IVD, ISO13485).

Many people are still not sure if technology can avoid/help beat chemotherapy. How are you raising awareness about how one can use technology to avoid/beat chemotherapy?

Initially, there was limited awareness about such tests in India. We have worked on creating awareness amongst doctors about CanAssist Breast through conferences, CMEs, seminars, webinars, WhatsApp campaigns, emailers, blogs, radio programs, corporate talks on Mothers Day or Breast Cancer Awareness Month.

Also, we have added more validation data, increasing the confidence of doctors in our test. Further, we have launched patient assistance programs to ensure that patients don’t lack access to the test for financial reasons. Our test is also now reimbursable by health insurance companies in India, removing one more barrier to use.

CanAssist Breast was commercially launched in 2016. We did a lot of awareness-building activities. We also got distributors involved to increase our reach across India.

What is the standard procedure of using the product?

CanAssist Breast falls under the class of prognostic tests. It is performed only on Hormone receptor-positive and HER2 negative breast cancer patients in the early stages. The test is performed on the patient’s surgically removed tumour sample which is preserved in the hospital laboratories. When a patient is diagnosed with early-stage breast cancer, there is a dilemma in the doctor’s mind whether the patient will benefit from chemotherapy or not. Through this test, they can overcome this dilemma.

CanAssist Breast essentially looks at the biology of the tumour and how aggressive it is. It has been shown in multiple studies that two patients with the same sized tumours, one patient may not have cancer recurrence whereas the other patient may have a recurrence. The difference in these two patients is not the tumour size but the tumour biology.

One patient had an aggressive tumour whereas the other patient did not have. That’s the assessment CanAssist Breast provides. The test is performed on surgically removed tumour sample of the patient.  It assesses the tumour biology in depth by doing immunohistochemistry for five biomarkers/proteins which reflect the aggressiveness of the tumour.

How personalised is the procedure?

CanAssist Breast gives us a definitive ‘risk score’ using a machine learning-based proprietary statistical algorithm. The risk score is reflective of the patient’s risk of cancer recurrence in five years from diagnosis. Based on this score, clinicians plan the optimum treatment for the patients.  If the risk of recurrence is high, the clinicians will add chemotherapy to the treatment regimen whereas if the risk score is low, the patient can avoid chemotherapy and move onto to, radiation and hormonal therapies in breast cancer.

The company identifies ‘low-risk’ patients who will have the minimal benefit of adding chemotherapy to their treatment and ‘high-risk’ patients who will benefit the most by adding it. Because each patient’s tumour biology, size, grade are different, the result is highly personalized. The level of the biomarker expression in a specific patient’s tumour will influence their CanAssist Breast risk score, based on which the oncologist will determine treatment.

The product provides hope to know that cancer will not re-occur. Is there a way to find out its initial occurrence?

Initial occurrence of cancer is detected using a scan (mammogram or ultrasound) followed by a biopsy where a small portion of the suspicious lump or mass is removed from the body and then studied by pathologists. If malignant/cancerous cells are found, then further investigation is done to assess the type of breast cancer.  Many companies have products to screen/find out the presence of small breast tumours eg Niramai, UE Life sciences etc but OncoStem is not in the screening space.

Who are the other key members of the company?

OncoStem has main operations in Bangalore with a total 18 member multi-tasking team. The management team consists of the head of operations, finance and business development. Also, we have a few Onco-pathologists, research scientists with PhD and M Sc. Our Statistician is based in the US.  All members of the team are extremely talented and multi-task and all are critical for OncoStem’s success.

What is the future of the product? How optimistic are you?

OncoStem is currently working on the second test for breast cancer and similar tests for ovarian cancer. Research is underway toward identifying and characterizing novel drug targets for breast cancer.

We are working on full automation of our test CanAssist Breast. Also, we use an auto-stainer for immunohistochemistry. Further, we are working on digital pathology solutions that will allow complete automation and also decentralization. This will allow any hospital in the world to conduct the testing in their laboratory.

We are creating more awareness about the product to doctors and patients, ensuring the test can be reimbursed. We have seen year-on-year growth since launch and are confident that this trend will continue because the product adds value to the health-tech sector.

Funding of Oncostem

OncoStem Diagnostics has raised $9 million in a funding round led by Sequoia Capital and Artiman Ventures.

About Dr Manjiri Bakre 

She has a total of about 25 years of experience in academia and industry in Cell Biology. She did Bachelor and Master of Science in Microbiology/Biochemistry at R Ruia College, Mumbai and M S University of Baroda respectively. After that, she did a PhD in Cell Biology at the Indian Institute of Science, Bangalore. This was followed by 2 Post-doctoral fellowships in the US. One at Mt Sinai School of Medicine in NYC and the other at Moores Cancer Centre, University of California at San Diego. Following the fellowships, she has worked in Singapore and India for a few years each before incorporating OncoStem Diagnostics.

She has also been a Principal Scientist at Philips Research, Bangalore. Further, she has been the Group Leader, Science and Innovation Division, Avesthagen Limited, Bangalore.

 Her Prominent Accolades in a Nutshell

• Dr Manjiri is the only Indian to win the prestigious KBCF award and is also selected to deliver a talk at the Global Breast Cancer Conference (GBCC) this April 2018 at Incheon, South Korea.

• Was awarded the Best Entrepreneur- Global Women in STEM- Start-Up.

• She was also invited to be a panellist at the Indian Cancer Congress and a speaker at the Breast Cancer Foundation of India.

• She has delivered talks at the World Congress on Controversies in Breast Cancer, held at Barcelona, Spain and Biomarkers in 2015 at Toronto, Canada and received several accolades for them.

Patents to her credit

• Method of prognosis and predicting breast cancer recurrence, markers employed therein and kit.

• Method of prognosis and predicting breast cancer recurrence, markers employed therein and kit.

• Markers for identifying tumour cells, methods and kit.

• A method to direct differentiation of human embryonic stem cells in vitro into mesoderm and endodermal progenitor cells for use in regenerative medicine.

• A method for inhibition of angiogenesis, cell adhesion and cell migration.

• Regulation of PDE isoforms by direct interaction with Gi family G-protein alpha subunits.