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.

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.

BCAL Dx COMPETES IN THE GLOBAL FINAL OF THE 1776 CHALLENGE CUP

Last month, Dr Peter French took to the stage to represent BCAL Dx at the final global round of the 1776 Challenge Cup. This follows BCAL Dx’s successful regional round in Singapore earlier this year.

BCAL Dx was one of 60 finalists in the global round and one of only five companies to progress through to the global round from the Asia-Pacific regional finals.

The Challenge has taken place over the last six months, in 45 cities around the world. Judges had to select from over 1000 startups to progress through to the regional finals, culminating in the global finals with only a handful organisations – of which BCAL Dx was one.

The Challenge was an effective networking opportunity for BCAL Dx, with the opportunity to meet a number of connectors and potential investment partners with a specific interest in medical biotechnology. BCAL Dx was also hosted by the staff of the Australian Embassy, where we discussed the expanding biotech market and how to leverage Australia-US relations in this space.

1776 is a global incubator and seed fund helping startups transform industries that impact millions of lives every day—education, energy & sustainability, health, transportation and cities.

NEW COLLABORATION AS BCAL Dx RESEARCH IS INDEPENDENTLY VERIFIED

A paper published on 2 May 2016 has independently validated and peer reviewed BCAL Dx’s underlying science and gives further support to the development of the BCAL Diagnostics technology.

The paper, “Plasma lipidomics profiling identified lipid biomarkers in distinguishing early-stage breast cancer from benign lesions,” was published by a group of researchers at The Fourth Hospital Affiliated to Guangxi Medical University (China) and the Department of Medicine, Rush University Medical Center in Chicago.

Last month, Chief Scientist Dr Dharmica Mistry and Director, Dr Peter French, visited the group at their Chicago laboratories in the USA. Professor Younping Deng and Dr Hongwei Wang from the group were keen to collaborate with BCAL Dx and give BCAL Dx an entry point into the Chinese market.

Professor Deng has over 15 years’ experience in the lipidomic space and the group has data for lung cancer and prostate cancer, which further support the BCAL Dx’s scientific hypothesis.

The group has recently formed a new company in Shanghai and has just raised USD $10 million. It has excellent relations with the Chinese government and good access to hospitals throughout China for sample collection. The group has also acquired laboratory space to set up medical testing using their research and technologies.

BCAL Dx has begun drafting a Heads of Agreement with the Chinese group, which explores multiple models for this relationship and how both parties can move forward together.

The research team behind the paper, had used a different mass spectrometer and different methods and found that a panel of 15 lipid species had “high diagnostic value”.

In the training set, sensitivity and specificity were 83.3% and 92.7%, respectively. The Area Under the Curve in the training set was 0.926 (95% CI 0.869-0.982). Similar results were found in the validation set. They concluded that the combination of these 15 lipid species (increasing and decreasing) as a panel could be used as plasma biomarkers for the diagnosis of breast cancer. This independent validation further supports the BCAL Diagnostics scientific hypothesis through data the group has also acquired for lung cancer and prostate cancer.

DR MISTRY AN AFR YOUNG EXECUTIVE OF THE YEAR

DR MISTRY AN AFR YOUNG EXECUTIVE OF THE YEAR

On 8 July, Dr Dharmica Mistry was named by the Australian Financial Review (AFR) Boss Magazine as a Young Executive of the Year.

The six Young Executives named have been chosen for their potential as leaders, commitment to their careers and organisations, and ability to operate successfully under pressure. 

This award is the second prestigious awarded to Dr Mistry this year. In March, Dr Mistry was awarded NSW Young Woman of the Year.

Leadership development and succession management specialists DDI Australia worked with a panel of Australian CEO's and the editor of AFR’s Boss Magazine to select winners from the hundreds of entries received. Nominations were accepted for this prestigious award from those under the age of 35. 

Please join us in congratulating Dr Mistry!

Press Release

Dharmica Mistry Awarded NSW Young Woman of the Year

Sydney, 9 March 2016: Dr Dharmica Mistry, Chief Scientist at BCAL Diagnostics, has been named NSW Young Woman of the Year for 2016.

Dr Mistry and BCAL Diagnostics have been leading the way in developing a blood test to detect breast cancer, which has already had an over 90% detection rate in initial trials.

BCAL Diagnostics, where Dr Mistry is co-founder, is at the forefront of a diagnostic tool that is revolutionary. Once on the market, this technology will impact the lives of millions of women around the world.

Presenting the award, Premier of NSW, Mike Baird said: “The NSW Woman of The Year Awards shine a light on the accomplishments of the many extraordinary women in NSW. Each and every nominee has made an immense contribution to their community and deserves to be publically applauded.”

“It’s a great privilege to receive this award as an acknowledgement of the vision of BCAL Diagnostics. We are determined to transform the lives of women globally by creating an easily accessible blood test for the detection of breast cancer,” said Dr Mistry. 

The awards panel noted that without Dr Mistry’s “persistence, unfailing optimism and drive over the past eight years, a transformational global test may have never been developed”.

The award was presented as part of the NSW Women of the Year Awards, by the NSW Premier Mike Baird and Minister for Women Pru Goward, at a luncheon at Parliament House in Sydney.

BCAL Diagnostics Reaches Global Finals of 1776 Challenge Cup

 Singapore 9 March, 2016: BCAL Diagnostics has been selected as one of five winning startups from the India, Southeast Asia and Oceania Region that will proceed to the global finals of the 1776 Challenge Cup in Washington DC.

The 1776 tournament brings together world-changing startups in the running to win investment as well as harnessing international connections.

BCAL Diagnostics, based in Sydney, Australia, is determined to transform the lives of women globally by creating an easily accessible blood test for the detection of breast cancer.

“BCAL is at the forefront of a diagnostic tool that is revolutionary. This technology will impact the lives of millions of women around the world,” said Jayne Shaw, Chairman of BCAL Diagnostics.

Breast cancer is the most common cancer amongst women, but the current gold standard for detection – mammography – only has an accuracy of 40-70%, and is limited by various factors. Initial trials of the BCAL blood test have demonstrated an accuracy of over 90%

At the 1776 Challenge Cup global finals in June, 45 winners from nine regions will compete for over US$1 million in cash and equity prizes, and mix with investors, customers and media from around the world.

1776 is a global incubator and seed fund helping startups transform industries that impact millions of lives every day—education, energy & sustainability, health, transportation and cities.

BCAL Diagnostics was represented at the regional competition in Singapore by Dr Peter French, Director and Scientific Advisor, and Jayne Shaw, Chairman. Dr French will represent the company at the global finals.