IMNIS Industry Mentoring Network in STEM

Working in the Australian biotechnology industry since 2007, scientist and entrepreneur, Dr Dharmica Mistry, shared the challenges she faced in moving from basic research to translational research and co-founding BCAL Diagnostics. With a PhD from Macquarie University, Dharmica is an inventor on one of BCAL Diagnostics’ founding patents and manages the scientific operations of the company.
 
 
 

Australian Scientists behind a game changing discovery

Dharmica Mistry is one of the Australian scientists behind a game changing discovery that will make it possible to detect breast cancer through a blood test. Studies so far indicate an accuracy rate of 90 per cent. Mammography, by comparison, has a 65 to 80 per cent accuracy rate, depending on breast density. The test might even be able to detect other types of cancers, too. 
 
 
 

The Future is Female – InStyle

Dr Dharmica Mistry announced as 1 of 3 nominee finalists  in the Science category, for the “InStyle Women of Style Awards” by InStyle Magazine Australia.  (April) issue of InStyle magazine.

Announcement of the winner will be in May at an awards ceremony.

THE REVOLUTIONARY BLOOD TEST TO DETECT BREAST CANCER

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 

Read more…

Young shire scientist’s discovery of simple breast cancer blood screening test set to undergo clinical trials

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..



Scientific Advances

Independent Publication

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

 

Commercial Progress

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.

Scalability

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.

Clinical Trials

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.

 

High Profile in Australian Media

In the media , thanks to our Chief Scientist Dr. Dharmica Mistry, 2016 was a very strong year for publicity with Dharmica featuring (click on the image to go to the article):

In the Australian Financial Review (AFR) in February

In a in depth interview with Fran Kelly on ABC Radio National also in March

In the October edition of the Australian Women’s Weekly

As NSW Young Women of Year in March

Receiving the AFR’s Young Executive of the Year Award in July

In the December issue of Virgin Australia’s inflight magazine

All of these articles have helped raise awareness of BCAL Dx and our work on developing a unique blood test for breast cancer that fills the need for a more accurate, effective and practical screening test for breast cancer for all women everywhere – the BCAL Test.

BCAL Dx has also been actively involved in pitching to over 70 high profile individuals through the “Heads Over Heels” network.

At the Sydney-based event, Dr Dharmica Mistry gave a seven-minute pitch to a room full of key decision makers followed by the opportunity to interact with all members of the audience with the aim of making high level connections with potential investors, key figures in government and high profile individuals in the breast cancer space. This has already resulted in several key meetings.