Manjiri, a PhD cell biologist from the Indian Institute of Science, Bangalore founded OncoStem Diagnostics in 2011 on her return to India after working globally at Mount Sinai School of Medicine, Moores Cancer Center, Genome Institute of Singapore and Philips Research to name a few. We speak with her to learn about the utility of developing a low cost innovative product and it’s impact on treatment decisions by physicians.
OncoStem Diagnostics is backed by Sequoia Capital India, Artiman Ventures and India’s Biotech Queen Kiran Mazumdar-Shaw.
CanAssist Breast is ISO 13485 certified, CAP accredited and CE (IVD) marked.
It is highly commendable what you and OncoStem Diagnostics have been able to achieve in the realm of breast cancer. Tell us about OncoStem Diagnostics and the idea behind starting a diagnostic company.
OncoStem is an Oncology Diagnostics company that focuses on developing innovative tests in personalized medicine space. Our tests which are performed on the patient’s individual tumor help clinicians to plan personalized treatment for each patient based on tumor biology. Our first focus is breast cancer.
Today, almost ninety-five percent of early-stage (Stage 1 & 2) breast cancer patients get Chemotherapy to avoid cancer recurrence.
However, chemotherapy typically benefits only about 10% – 15% of patients with early-stage breast cancer. Chemotherapy also has huge toxic side effects which reduce the patient’s quality of life substantially. At OncoStem, we are trying to solve the problem of finding which early-stage cancer patients have a high chance/risk of recurrence that can help them in optimum treatment planning. In short, we develop tests to determine the molecular fingerprint of the tumor and assess the aggressiveness of the tumor. Clinicians use that information to devise tailor-made therapeutic strategies for each patient.
Please describe the CanAssist Breast (CAB) technology?
CAB technology: We perform immunohistochemistry (IHC) for 5 selected biomarkers which are graded by Pathologists, the gradings of these IHC slides plus tumor size, grade and node status of the patient is taken as input for our proprietary machine learning based statistical algorithm. The algorithm gives us a risk score (0-100) based on which patient is stratified as either low-risk or high-risk for cancer recurrence.
What was the basis for selection of the prognostic biomarkers used in CAB?
Prognostic biomarkers: Cancer recurrence is the consequence of activation of multiple critical signaling pathways such as invasion, migration, EMT, and MET beyond mere cell proliferation. There are multiple key proteins belonging to these signaling pathways which are reflective of the aggressiveness of cancer. We therefore specifically made a list of critical signaling pathways and important biomarkers from these pathways and analyzed the expression of these proteins in tumors.
Is the test developed based on cancers observed in the Indian population?
Yes, CanAssist Breast is developed using tumor samples from Indian patients. Additionally, it has been validated on Indian, American, and European patients as well. Over the last 2 years, more than 350 patients from Indian sub-continent have used CanAssist Breast for optimum treatment planning.
The average age of an Indian woman who presents herself with breast cancer is lower in India than those of the women in the West. Younger women in India are found to exhibit a more aggressive form of cancer that is not hormone sensitive. Can these women also benefit from CAB?
CanAssist Breast is meant for women with hormone receptor (HR) positive breast cancer irrespective of age. Thus, the younger patients in India can use CAB, provided they have Hormone receptor-positive diseases. For women with Hormone Receptor-negative diseases, we are working on developing an additional test which will be marketed in a year’s time.
How would you describe the ideal candidate who can benefit most from CAB?
Patient must meet the following criteria to be eligible for CanAssist Breast:
- Patients with hormone receptor-positive (ER+/PR+; ER+/PR-; ER-/PR+) and HER2- disease
- Pre or post-menopausal women
- Patients with early-stage, invasive breast cancer
- Patients who haven’t gone through neoadjuvant chemotherapy
- Patients who are not diagnosed with DCIS
- Lymph node-negative or up to 3 lymph node-positive
Once the patients meet the test eligibility criteria, the doctors must prescribe CanAssist Breast to customize the treatment for every patient.
What are the benefits of opting for CAB?
CanAssist Breast helps to identify the likelihood of breast cancer returning post-surgery. Our test classiﬁes patients as ‘low risk’ or ‘high risk’ based on the patient’s risk of breast cancer recurrence over ﬁve years. Up to 3 out of 4 early-stage breast cancer patients are likely to have a low risk of breast cancer recurrence.
Each patient’s cancer is unique. If you have been diagnosed with early-stage, invasive breast cancer, it is likely that you may not beneﬁt from chemotherapy. Once your risk of breast cancer recurrence is known, you can consult your doctor to personalize your treatment plan and possibly avoid the side-eﬀects of chemotherapy. Thus in short the benefits of opting for CAB are:
- Assess risk of cancer recurrence and know if you will benefit from chemotherapy
- If you have high risk of cancer recurrence, you can potentially get more frequent follow ups to monitor the disease better
- Improved quality of life if you do not need chemotherapy
Recognized as one of the leading woman entrepreneurs in India do you feel that there is enough innovation in the field of cancer in India?
The landscape of cancer detection and treatment planning is changing rapidly across the globe and India is not lagging behind. I think there are many good companies doing innovative work in the field of cancer to name a few- AINDRA systems, Niramai in the cancer detection space, OncoStem and Mitra biotech, Medgenome, Strand life sciences in the treatment planning stage, Navya networks and onco.com in informatics, and second opinion space. There are a few more companies in the field as well (eg; diagno strings) plus many academic labs are doing research in cancer as well.
So as I see it, there are enough companies doing innovative work but these companies need to get more visibility and support from the government such as inclusion in -government insurance scheme, national guidelines for treatment of diseases by ICMR, and inclusion by private insurance companies to name a few. This will help the innovations to reach a maximum number of people.
Prognostic assays that predict the risk of recurrence is a relatively new concept in India. Introducing CAB in India requires making inroads in a space that requires changing conventional methods of giving chemotherapy. Do you find clinicians are well versed in the prognostic tests available and see CAB as filling a need?
Yes, many clinicians are aware of the existing Western prognostic tests which are expensive and thus are out of reach. However, we still find that not all clinicians are aware of CanAssist-Breast. We certainly need to market CAB to more clinicians.
Existing multi-gene tests are expensive and most importantly not validated on Indian patients. Many clinicians appreciate that CAB is validated extensively on Indian patients and realize the gap it fills and they recommend it to the patients.
Have you implemented programs to increase awareness about CAB among doctors and patients?
Yes, we carry out regular Continued Medical Education (CME) programs across India and outside India to increase the awareness about CAB. We actively participate in conferences and constantly update the doctors through our publications. We will also be participating in Patient Awareness Programs to educate them about CanAssist Breast.
Has the lower cost and local testing access advantage that the CAB platform offers compared to samples that need to be shipped abroad, helped in easier market penetration?
Yes. As other tests are prohibitively expensive, CAB’s low cost and shorter turn-around time have helped us in easier market penetration.
In which segment (geographic/socioeconomic/age/ type of prescribing doctor) is the test being prescribed the most?
CAB has been prescribed across India, primarily in private hospitals and across age groups varying from 30 to 75 years.
Is CAB covered by insurance?
Yes, CAB is covered by private insurance companies such as Star Health. We are working with more insurance companies to drive further adoption.
There has been a lot of discussion on patient data and India. How do companies like yours manage patient data?
The Medical Council of India (MCI) code of Ethics Regulations mandates that all patient data be protected from unauthorized use. This is also a requirement of accreditation bodies like NABL (The National Accreditation Board for Testing and Calibration Laboratories) and CAP and all accredited labs are audited for compliance with this requirement. OncoStem is CAP certified and NABL accredited and takes patient confidentiality seriously. It follows HIPAA guidelines as well that cover international standards for patient confidentiality and data protection.
How do you ensure the integrity of patient data?
We ensure data integrity by password-protected access to patient data, allowing data access only to authorized users. All authorized users have signed a confidentiality agreement at the time of joining the company and are legally bound not to misuse patient data. All patient data is stored on secured servers that are periodically backed up.
Do you share the data with any registry?
We don’t share the data we generate with any registry.
Who owns the data?
Data is owned by OncoStem.
What has been the biggest hurdle in rolling out CAB in India?
As with any new test, the major problem we face is acceptability of a new test by physicians. It is partly due to the lack of trust in any test developed in India and partly due to the non-inclusion of the test in guidelines and recommendations like the ICMR (Indian Council of Medical Research) and NCCN (National Comprehensive Cancer Network) guidelines. The acceptability is slowly but steadily improving with more than 50 doctors repeatedly prescribing CanAssist-Breast. We have also cleared the first round of ICMR approvals where they clearly recognized the merit of the test and are awaiting the decision of the Breast Cancer Committee to include CanAssist-Breast in the next edition of the guidelines. Additionally, patient awareness is on the low side in India and that is another hurdle since if the patients are aware and ask about CAB to doctors it will be helpful as well.
What do you envision for OncoStem Diagnostics in the future?
OncoStem’s goal is to be the go-to oncology diagnostic company with a panel of innovative tests required for personalized treatment planning for multiple cancers. Our first focus is breast cancer and CAB is launched in India and near India markets. We are working on automating CAB end-to-end so that we can package it as a kit to be performed at respective hospitals. This will help us to increase the footprint in reducing turn-around time as the business grows. We are entering into Asian markets this year and this will be followed by launching CAB in Middle East, Europe and US.
We are working to add more innovative tests for additional cancers and towards that goal development of tests for oral and ovarian cancers are already underway.
Thank you Dr. Bakre for your time. Your insights are greatly appreciated.
Disclaimer: Interviews are published unedited or with minimal changes.