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OncoStem Diagnostics: A 'Made in India' test that is unprecedentedly accurate, bestowing breast cancer patients with peace of mind

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Manjiri Bakre, Founder & CEO, OncoStem DiagnosticsWe have come a long way from the era when surgery was the only treatment modality for breast cancer and has reached several milestones akin to radiation therapy, chemotherapy and targeted drug therapy. Treatment strategies are continually evolving. Amidst the massive 1.5 lakh breast cancer patients in India, a good proportion (~50 percent) of patients are diagnosed at an early stage (Stage 1 & 2)and a majority of them can be potentially spared from chemotherapy based on the tumor biology. Unfortunately until recently the clinicians did not have anything beyond the clinico-pathological parameters (tumor stage, grade, hormone receptor status) to decide on the treatment options. Thus, most of the patients even in early stage are being given chemotherapy- a treatment that is associated with toxic side effects (like hair loss, diarrhoea, toxicity to liver and heart, compromised immune system, and infections, to name a few) which most of the times outweighs the benefits of chemotherapy in early stage disease.

While lowering one’s quality of life, chemotherapy takes its toll on the fertility of younger patients and it subjects the elderly patients (whose ability to fight infection is less) to incessant struggle, not to mention the fact that it is a costly affair. This is where OncoStem Diagnostics,one of India’s first completely IP-driven, product-focused companies in the industry, enters the picture with its flagship product called ‘CanAssist-Breast’– a ‘Made in India’ product that accurately assess which early stage patient(from about 45 percent of the total breast cancer patients) has a high chance of future cancer recurrence, thus facilitating clinicians to plan optimal treatment, without getting over-treated or under-treated.

Driving the Wave of Transformation
Developed indigenously by an Indian team and stacked with global accreditations, Can Assist-Breast has dispelled the myth that India always looks up to the west to develop world-class technologies. The ‘Made in India’label has a deeper meaning than merely being a matter of pride or means for cost-cutting.Indians tend to get breast cancer a decade earlier than those in the West. Hence, a diagnostics test developed in the west would naturally assess the Indian patients with different parameters in terms of the disease’s biology, metabolic rate of women,the way she processes drugs and so forth; thereby potentially producing an inaccurate result.

This draws us back to the rationale on why CanAssist-Breast – the first test to be developed& validated on Indian patients, transcends as OncoStem’s biggest strength. It further stands out even amongst several of the competing western tests as a pioneer in using Machine Language based statistical algorithm, which makes it far superior than the rest in not only ranking the biomarkers and outcome prediction, but also in terms of delivering results within a rapid turnaround time. And of course, born and bred in India, it is hands down the most affordable test vis-a-vis all other competing tests available today for Breast Cancer, thereby lowering the barrier to entry and getting the less fortunate demography started on the path of wellness.

Yet another salient feature that bends the arc of history towards India is the biomarkers utilized by Can Assist-Breast, which are reflective of the elements needed for the tumour to have a recurrence at a distant site in the body. Hence, unlike most competing tests that merely focus on cell proliferation, CanAssist-Breast also sheds light on other critical signalling pathways in tumour recurrences and biomarkers that are responsible for tumour spread across the body. Noting that the biomarkers unearthed by the test can be used to create new targeted drugs for those specific cancer patients, the firm plans to partner with pharma companies for developing those drugs against its biomarkers.

Rigorous Quality Management Processes
Besides CanAssist-Breast, OncoStem also offers basic services such as hormone receptor status, growth factor receptors constituting breast cancer biomarker panel with a deep emphasis on quality of reports and patient safety. OncoStem signs NDA with hospitals & its employees and safeguards their data with ironclad security, though the hospitals don’t reveal the patient’s name & other identifiable details to them. Besides obtaining ethics approval(IRB)from each hospital to perform this research,OncoStem has earned several certifications& accreditations (NABL, NABH, CE-IVD, ISO13485) from India, Europe that enforces it to adhere to certain rigorous quality management processes & regulations as per
international guidelines, wherein every equipment is tested, standardized and calibrated. For instance, the firm is audited annually for ISO:13485 (CanAssist-Breast test) which ensures that everything from getting samples, sending reports and getting patient’s feedback is documented and followed in compliance.

Developed indigenously by an Indian team and stacked with global accreditations, CanAssist-Breast has dispelled the myth that India always looks up to the west to develop world-class technologies


Making the Impossible Possible
When Manjiri Bakre(Founder& CEO) proposed her idea of developing a product that utilizes the patients’ long term clinical data to devise a diagnostic test, many clinicians & hospitals raised the red flag to warn that digging out the data of last five years & developing it into a test would be a tall order in a country where maintaining proper records is not the norm. She never bought and gave in into such generic statements. Manjiri was confident that an Indian team imbued with focus & honesty has the potential to adeptly perform such a diligent work. With a stronger resolve, she pulled out all the stops to harness a good collaboration between a multi-disciplinary team comprised of pathologists, researchers, statisticians and oncologists for developing the product. Excellent advice from mentors such as Kiran M Shaw, Venkatadri Bobba, Samir Kumar on the venture side, Dr. Mark Pegram, Dr. Sudeep Gupta, Dr. Harit Chaturvedi on the clinical side apart from investors has helped her tremendously. Team of doctors at Manipal hospital Bangalore including Dr. Somashekhar and Dr. Poonam Patil have been very helpful in brainstorming and promoting the science behind as well.

“If we put our mind,focus and be detail oriented as a team, together,we can achieve anything, no matter how difficult it is,” asserts Manjiri. It is this relentless passion to bring an unprecedented innovation filling the wide market gap to life that propelled Artiman Ventures to pour funds into OncoStem in 2011, even though Manjiri had nothing more than an idea drafted into a PowerPoint presentation. Much to their delight, the firm had CanAssist-Breast, their flagship product developed, validated, accredited and rolled out in 2016 with an NPV of 95 percent. Ever since OncoStem initiated its marketing endeavours in the middle of 2016, OncoStem has been experiencing a steep growth. With Sequoia Capital India joining onboard in 2017, the company’s growth shows no sign of coming down anytime soon. In fact, OncoStem today works with ten different hospitals in India including major multi-specialty chains like Manipal Hospitals, cancer specialty chains like Rajiv Gandhi Cancer Institute(Delhi) and smaller breast cancer specialty centres.

Redefining Teamwork
Humbly refusing the notion that Manjiri is the sole reason behind OncoStem’s success, she states that it is a combined effort of her highly talented team of scientists and a proficient management team comprised of Dr. Chetana Basavaraj (Laboratory Director), Satyanarayana Thallam(COO),Nanjunda Prasad R(VP-Sales& Business Development)& Sandeep Prabhu(CFO). The company not only hones its team’s skills by encouraging them to participate in diverse certification programs, conducting internal training sessions and attending in various conferences worldwide, but also sends out emails to its clinicians regarding the latest scientific publications. “In April, I attended a breast cancer related conference in Korea and shared the knowledge with everyone. We’ve been selected to present posters and do oral demonstrations in multiple international high calibre conferences like San Antonio Breast Conference and European Society of Medical Oncology Conference,” shares a proud Manjiri.

Redefining teamwork, everyone at OncoStem wear different hats, wherein the regulatory compliances are handled by scientists with surgical precision. “When the auditors assess us and appreciate our work, it’s very gratifying. I strongly believe that there’s no job beneath me and try to instil that as our culture,” she divulges. The incident when Manjiri decided to climb up nine floors of stairs in a hospital to not miss a timely appointment, instead of waiting for the lift for 15 minutes, illustrates the heights she is willing to go for OncoStem’s progress.

New Heights to Conquer
OncoStem is developing a first-of-its-kind product for Triple Negative Breast Cancer patients, which will cater to about 30 percent of patients who currently have no means to assess their recurrence rates. On the other hand, judged as a poor man’s disease, the rampant oral cancer persisting in India and other Asian countries are being largely ignored. By taking yet another bold step, OncoStem is building tests for oral cancer to facilitate the patients to get appropriate treatments. Also innovating on platform-front, the firm that developed a Proteomics based platform for CanAssist-Breast is presently working on a Genomics based platform.

With its plan to make a fierce foray into Asian, Middle Eastern and U.S. markets, OncoStem anticipates amassing even a better figure of revenue in 2018. En route to achieve this, the firm is on the way of getting the CAP (Quality of American Pathologist) accreditation in U.S. and are submitting documentations this year to obtain US FDA 510K approval for CanAssist-Breast test. It also intends to setup another lab to cater to the entire Asian market. Currently offering its test as a central lab based service, OncoStem desires to evolve by completely automating its tests and garner digital pathology solutions to enable every hospital around the world to perform tests in their own premises. Keen on signing up nationwide diagnostic chains to achieve a longer reach of its services from Kashmir to Kanyakumari, OncoStem hopes to touch the lives of every needy patient across India via these chains and direct tie-ups.

Key Management:
Manjiri Bakre, Founder & CEO
Holding several patents to her credit, Manjiri is a Cell Biology & Cell Signalling veteran with 25 years of experience in research and technology in India, U.S. and Singapore, She has won many awards including Young Scientist and had her paper published in Nature Medicine.

Certifications: Certificate of CE (IVD) notification, ISO 13485:2003, NABL – ISO 15189:2012, NABH – Certificate and more on the way

Achievements:
• Korean Breast Cancer Foundation Award in 2018
• Featured in Top 100 start-ups to watch by Sutra in 2018
• Manjiri won Best entrepreneur award by US based Meera Kaul Foundation in 2016