Dr Dharmica Mistry is one of the Australian scientists behind a groundbreaking discovery that will make it possible to detect breast cancer through a blood test.
It was pure chance that led Dr Dharmica Mistry to make the discovery that could change the lives of millions of people affected by breast cancer.
Since that day, Mistry has left nothing to chance. She’s dedicated the past nine years of her life to developing that scientific breakthrough.
08 Mar 2017 Author: Imogen Brennan
While 2016 was a big year for Dharmica Mistry, a young scientist from Sydney’s south, the next 12 months will be even more important.
Dr Mistry’s discovery that a simple blood test could be used to screen women for breast cancer led to her being named the 2016 NSW Young Woman of the Year.
Her work is due to be subjected to clinical trials in the community this year and, depending on the results, the test could be on the market as early as 2018. Read more..
The young scientist discovered the oil from the human scalp could be reliably used to test for breast caner. Now she is working as chief scientist for BCAL Diagnostics a Sydney-based company..Read more
BCAL Dx’s approach to testing for breast cancer has been further independently validated with the publication of a paper by a group at Rush Medical University in Chicago. Their paper, highlighted in our July Newsletter, gave further strong support to BCAL Dx unique approach. The company is well advanced in collaborative discussions with this group to further enhance the BCAL Test.
BCAL Dx Publication
In November 2016, Dr. Dharmica Mistry and Dr. Peter French published an article in a peer-reviewed journal on behalf of BCAL Dx. The article, "Circulating Phospholipids as Biomarkers of Breast Cancer: a review” provides the theory behind the BCAL Dx technology. The publication of this paper is further strong endorsement of BCAL Dx’s approach and highlights the scientific credibility associated with the BCAL Test. Other publications are being prepared to build on this first article. Download PDF
In August 2016 BCAL Dx welcomed Carl Stubbings to head the company’s commercialisation efforts. Carl has considerable experience in the commercialisation of diagnostic products with a particular focus on the USA. Carl’s bio is available on the BCAL Dx website.
Regulatory Strategy and Market Roll Out
BCAL Dx is pleased to report that the company has finalised our launch strategy for the BCAL Test, focusing on the USA and Australia. The test will be launched in the US as a “Laboratory Developed Test” (LDT) which is defined as an in vitro diagnostic test that is manufactured by and used within a single Clinical Laboratory Improvements Amendment (CLIA) certified “high complexity” laboratory. This pathway to market is a common one utilised by a number of laboratory providers in the USA. In 2014 over 244,000 different tests were noted as being regulated by CLIA and not the US Food and Drug Administration (FDA). This approach is also available in Australia, where the company will undertake a similar strategy. The LDT approach could enable the BCAL Test to become available in late 2017 or early 2018, a significantly shorter pathway compared to FDA and Therapeutic Good Authority (TGA) approvals. In parallel, BCAL Dx will also initiate a regulatory strategy with a goal of obtaining approvals from the FDA and TGA (Australia) by Q2 2019 further broadening uptake of the BCAL Test.
During the last 12 months BCAL Dx, in conjunction with our US collaborators at University of Kentucky and Sevident Technologies, have made excellent progress towards finalising a testing platform that will enable the BCAL Test to be easily scalable into a routine pathology laboratory setting. The company expects to finalise this important step in Q1 2017.
This milestone will coincide with the completion of an important clinical trial. In January 2017, BCAL Dx expects to complete a 110 patient blind study which will further validate the scientific foundation behind the BCAL Test.