OncoStem Diagnostics, an oncology-focused company that enables personalised cancer treatment, has successfully completed its first-ever single-centre, blinded validation study in Europe. The study, conducted in association with Vall d'Hebron Institute of Oncology (VHIO), Spain, involved retrospective validation on a set of 290 patient samples with an accuracy of 96 per cent. The result of this study was on par with the accuracy seen in the previous studies conducted by OncoStem diagnostics.

OncoStem’s CanAssist Breast is a prognostic test for early-stage hormone receptor-positive breast cancer patients. It makes customized treatment possible by analysing the patient's tumour in-depth and providing a patient-specific report. CanAssist Breast categorizes patients based on the biology of the tumour as either ‘low or high’ risk for cancer recurrence. This clear distinction of patients based on the 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 of chemotherapy treatment. 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.

The retrospective study performed in collaboration with VHIO, Spain was conducted on samples of breast cancer patients ranging in age from 28 to 92 years. The mean age at diagnosis was found to be 61 years and the predominant tumour size was T1 (less than 2cm tumour), in line with previously reported data on Caucasian cohorts. In India, the mean age at diagnosis is about 48 years and T2 (2-5 cm tumour) tends to be the predominant tumour size. Despite these differences in the patient profile, the accuracy of CanAssist Breast risk classification in the Caucasian population was found to be the same as what was seen in OncoStem’s Indian studies (96 per cent NPV). This suggests that CanAssist Breast test can be used across all age groups and across a broad range of clinical presentations of early-stage breast cancer.

Speaking about the validation, Dr Manjiri Bakre, CEO and Founder, OncoStem Diagnostics said “We are very encouraged by the results of this study as it demonstrates that CanAssist Breast has universal applicability. This validation has taken us a step closer towards our goal to globally validate CanAssist Breast and provide patients with a world-class product.”

OncoStem Diagnostics presented the validation study data at the recently concluded annual ESMO (European Society for Medical Oncology) Congress 2019 in Europe.