OncoStem Diagnostics: Developing Innovative Prognostic and Predictive Solutions

OncoStem Diagnostics
Dr. Manjiri Bakre | Founder & CEO | OncoStem Diagnostics

For the general mass, the word Cancer elicits fear; of the unknown and of certain death. Cancer indeed is a complex disease which not only affects the patient, but the complete family. It doesn’t only affect an individual’s health, but other aspects like social, professional and financial life as well.
When Dr. Manjiri Bakre lost a dear one to the disease, she was determined to know what exactly went wrong. She founded OncoStem Diagnostics in 2011 with a vision to develop tests that help to identify patterns of cancer recurrence risk. An understanding of these patterns ensures that patients receive personalized therapies and treatments that are best suited to their condition.
The following Interview with Dr. Manjiri highlights the need of understanding the tumor biology in optimizing therapy for cancer patients.

  • Kindly brief us about the company and its initial journey.

I founded OncoStem in 2011, after being moved by the death of a close friend due to breast cancer. She died despite being diagnosed with early-stage disease, maybe due to a limited understanding of the tumour biology driving the disease. Companies in the West were developing tests that could analyze tumour biology and determine the risk of relapse in patients with early-stage breast cancer patients. These tests could help personalize a patient’s treatment plan based on that patient’s individual risk of relapse. Since these tests are very expensive, I approached doctors in India and pitched my idea of developing a home-grown and affordable version of such a test.

  • Brief us about you and your role in the Company?

I am the Founder and CEO of OncoStem Diagnostics. I wear multiple hats in OncoStem and enjoy managing just about every aspect of OncoStem.  There is really nothing beneath me or nothing that I would not want to do. If I do not know about some task I will read up, talk to the experts and learn it to do it well. I have started right from setting up the laboratory infrastructure, purchasing consumables to hiring and training first 2-3 employees.  I do fund raising, look into finances, take care of Scientific aspects, legal and patenting, plan out new tests and research avenues.  Speaking with clinicians for marketing the test, attending conferences to bring in more collaborations, marketing the test, finding new partners to work with us within India and abroad.  I have a team of 30 very capable people now and they help me many aspects.

  • Brief us about the services that the company offers.

OncoStem has developed a prognostic test called “CanAssist Breast”, early-stage hormone receptor positive breast cancer patients. It makes customized treatment possible by analysing the patients tumor in depth and providing a patient specific report. CanAssist Breast categorizes patients based on the risk of cancer recurrence clearly as either ‘low or high’ with no grey area in between. This clear distinction of patients based on risk of cancer recurrence allows doctors to devise treatment plans that are in tune with the prognosis, maintaining a balance between the benefits and side effects. Patients who are at low risk of relapse can potentially avoid chemotherapy and its associated side-effects while patients who are at high risk of relapse would benefit from the addition of chemotherapy to their treatment regimen.

  • What are the challenges in this Sector in India?

Conducting validation studies in India can be challenging because the clinical trial framework is not as well established as developed countries. I must have approached 50-60 hospitals to work on developing and validating CanAssist Breast, which ultimately led to 10 hospitals signing up. There are many reasons for this – 1) one is that the doctor-patient ratio in India is well below the developed world. Each oncologist in India sees many more patients per day leaving them with little time to focus on research studies. 2) Lack of documented patient records and follow-up also makes it difficult to conduct studies that require patient history. Patients often move back to their hometowns after treatment and are lost to follow-up. 3) Lack of enforcement and encouragement of importance of research studies, clinical trials, detailed documentation from government and regulatory authorities.  If they enforce and encourage these activities, we can develop far more world class diagnostics, drugs and medical devices than currently doing.

  • What are the unique propositions that the centre offers giving it an edge over competitors?

Our product CanAssist Breast is the only test to be validated on Indian patients. Competitors are developed and validated in Western countries, on Caucasian patients. Caucasian breast cancer patients tend to be older and post-menopausal at diagnosis, whereas their counterparts in India tend to be younger and pre-menopausal. Our USP is that we have taken this into consideration right from test development. Our offering is the only product to have data on Indian patients. We are also the most affordable offering in the market today, giving us another edge over prohibitively expensive Western tests. Finally, our trun around time is the shortest so we report within 8-10 days compared to 3 weeks taken by some of the competing tests.

  • What are the key points that you consider while opening a new centre?

Quality is key. Given the impact on a patient’s health, all medical testing should be done in a quality controlled environment by qualified and well trained personnel. The proper accreditations should be in place, as this ensures that laboratories follow a quality management system and face regular quality audits. At OncoStem Diagnostics, we strive to maintain the highest quality. Our laboratory has been audited and certified by National Accreditation Board for Testing & Calibration Laboratories (NABL) and College of American Pathologists (CAP) for upholding quality systems as per ISO 15189. Our laboratory also participates in various external quality assurance schemes including the one run by the National Cancer Grid based out of Tata Memorial Hospital in Mumbai. Our test CanAssist Breast is CE marked, making it eligible for sale in the European Union.

  • Please share the latest technology that the centre is utilizing to offer better services.

OncoStem flagship product ‘CanAssist Breast’ test uses a cutting edge machine learning-based algorithm to predict the risk of recurrence for patients. Machine learning is known to be a more advanced tool to develop prognostic tests where patterns of patient information need to be understood and analysed. We are also working on full automation of the test, including digital pathology, so that it can be sold as a kit and performed in a decentralized manner in the future. This will reduce the turn around time and also allow the test to be performed in a standard manner irrespective of which laboratory is doing the test.

  • How does the firm intend to handle its Societal Responsibility? Please mention any special charity or program as such.

OncoStem partners with key opinion leaders in oncology and supports them in conducting breast cancer screening camps and other awareness programs. We do this through doctors to ensure that patients get the right advice from qualified medical professionals. We are looking to reduce the price of the test for public sector institutions so that more and more patients are benefitted. We are also looking partner with NGO’s who work in the breast cancer space and can support patients in their treatment journey.

  • What are the company’s views regarding the spurious growth of uncertified and illegal centres that crop up?

This can be really damaging to patients as accurate diagnosis of disease is the first and most important step in their treatment journey. Incorrect test results can have a life-changing and often irreversible impact on the health of a patient. Major surgeries and treatments are planned based on the result of medical tests. Unfortunately, only 1,038 out of 1,00,000 labs are accredited by National Accreditation Board for Testing & Calibration Laboratories (NABL), which is less than 5% of all labs in India. Ideally, all labs should be accredited by the national body as is the case in developed countries. To ensure affordable testing in India, we should look at other measures that can lead to lower costs rather than compromising on quality.

  • Brief us about the company’s future perspectives.

OncoStem is working to globally validate its “Made-in-India” test CanAssist Breast, by undertaking studies across multiple continents. We are also working with pharmaceutical companies to develop targeted drugs based on the learnings from CanAssist Breast, which can help treat those patients who don’t respond to conventional therapy. And finally, we are also working to build a pipeline of tests that can personalize treatment for other cancers like ovarian cancer.

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