New Risk • Feb 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$6.5m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.5m free cash flow). Earnings have declined by 31% per year over the past 5 years. Minor Risks Revenue is less than US$5m (AU$2.5m revenue, or US$1.8m). Market cap is less than US$100m (AU$44.2m market cap, or US$31.3m). Board Change • Feb 04
Less than half of directors are independent Following Non-Executive Director Mark McConnell's arrival on 01 February 2026, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent Non-Executive Director & Consultant John Hurrell was the last independent director to join the board, commencing their role in 2024. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Ankündigung • Oct 29
BCAL Diagnostics Limited, Annual General Meeting, Nov 28, 2025 BCAL Diagnostics Limited, Annual General Meeting, Nov 28, 2025. Location: at gadens level 29 8 chifley square, sydney nsw 2000 Australia Ankündigung • Oct 21
BCAL Diagnostics Limited announced that it expects to receive AUD 10 million in funding BCAL Diagnostics Limited announced a private placement of Convertible Notes for gross proceeds AUD 10,000,000 on October 20, 2025. The notes have interest rate of 10% per annum and matures on 2 years from the Notes’ issue date. The transaction subject to shareholder approval.
The notes are expected to be issued on November 26, 2025.
On same day, the company announced it has raised AUD 5,000,000 in its first tranche. Reported Earnings • Aug 31
Full year 2025 earnings released: AU$0.02 loss per share (vs AU$0.026 loss in FY 2024) Full year 2025 results: AU$0.02 loss per share. Net loss: AU$7.24m (loss widened 13% from FY 2024). Ankündigung • Mar 25
BCAL Diagnostics Limited Announces the Commercial Launch of BREASTEST Plus BCAL Diagnostics Limited announced the commercial launch of BREASTEST plus. This first-in-class blood test is available from 27 March 2025 and will be used alongside standard-of-care imaging in breast cancer screening and diagnostics. The Company is pleased that this launch has been achieved within the previously announced target timeframe of having the test commercially available in Australia by the end of first quarter CY2025. BREASTEST plus has been validated to meet the challenge of high breast density, which affects approximately 50% of Australian women participating in breast cancer screening programs. High breast density masks abnormal lesions on mammography, in many cases making it difficult to diagnose. In line with the Company's stated market entry strategy, BREASTEST plus will provide clinicians with a new, additional tool to help overcome this longstanding challenge. BREASTEST plus will be available at Sydney Breast Clinic from Thursday this week, with a planned roll out to additional select clinical sites, initially in Sydney and Melbourne, to follow. BCAL is focused on ensuring a systematic national rollout, working closely with clinical partners, to ensure Australian women will have access to BREASTEST plus™?. BCAL collaborated with its Clinical Advisory Board of eminent Australian breast surgeons, radiologists and physicians to develop BREASTEST plus™?, ensuring it meets the needs of women with high breast density who are often the most challenging to diagnose via traditional imaging. New Risk • Mar 24
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -AU$8.1m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$8.1m free cash flow). Earnings have declined by 43% per year over the past 5 years. Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$2.6m revenue, or US$1.6m). Market cap is less than US$100m (AU$42.1m market cap, or US$26.5m). New Risk • Mar 01
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -AU$8.1m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (45% increase in shares outstanding). Minor Risks Less than 1 year of cash runway based on current free cash flow (-AU$8.1m). Currently unprofitable and not forecast to become profitable next year (AU$1.4m net loss next year). Revenue is less than US$5m (AU$2.6m revenue, or US$1.6m). Market cap is less than US$100m (AU$36.2m market cap, or US$22.5m). New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 43% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (43% increase in shares outstanding). Minor Risks Revenue is less than US$5m (AU$3.1m revenue, or US$1.9m). Market cap is less than US$100m (AU$34.4m market cap, or US$21.4m). Ankündigung • Oct 04
BCAL Diagnostics Limited, Annual General Meeting, Nov 22, 2024 BCAL Diagnostics Limited, Annual General Meeting, Nov 22, 2024. Reported Earnings • Aug 31
Full year 2024 earnings: EPS misses analyst expectations Full year 2024 results: AU$0.026 loss per share (further deteriorated from AU$0.024 loss in FY 2023). Revenue: AU$3.10m (up 8.6% from FY 2023). Net loss: AU$6.40m (loss widened 26% from FY 2023). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 62%. Revenue is forecast to grow 78% p.a. on average during the next 2 years, compared to a 7.7% growth forecast for the Biotechs industry in Australia. Over the last 3 years on average, earnings per share has fallen by 25% per year but the company’s share price has only fallen by 14% per year, which means it has not declined as severely as earnings. New Risk • Jul 26
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 68% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Shareholders have been substantially diluted in the past year (68% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$1.5m net loss in 2 years). Revenue is less than US$5m (AU$3.7m revenue, or US$2.4m). Market cap is less than US$100m (AU$41.1m market cap, or US$26.9m). Ankündigung • Jul 25
BCAL Diagnostics Limited has completed a Follow-on Equity Offering in the amount of AUD 10.5 million. BCAL Diagnostics Limited has completed a Follow-on Equity Offering in the amount of AUD 10.5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 62,000,000
Price\Range: AUD 0.1
Discount Per Security: AUD 0.006
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 43,000,000
Price\Range: AUD 0.1
Discount Per Security: AUD 0.006
Transaction Features: Subsequent Direct Listing New Risk • May 29
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of Australian stocks, typically moving 14% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Currently unprofitable and not forecast to become profitable over next 2 years (AU$1.5m net loss in 2 years). Share price has been volatile over the past 3 months (14% average weekly change). Shareholders have been diluted in the past year (19% increase in shares outstanding). Revenue is less than US$5m (AU$3.7m revenue, or US$2.5m). Market cap is less than US$100m (AU$44.2m market cap, or US$29.3m). Board Change • Mar 22
Less than half of directors are independent There are 4 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 4 new directors. 4 experienced directors. 2 highly experienced directors. 2 independent directors (3 non-independent directors). Co-Founder & Non-Executive Director Ron Phillips is the most experienced director on the board, commencing their role in 2010. Independent Non-Executive Director Mark Burrows was the last independent director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of experienced directors. Reported Earnings • Feb 22
First half 2024 earnings released: AU$0.01 loss per share (vs AU$0.012 loss in 1H 2023) First half 2024 results: AU$0.01 loss per share (improved from AU$0.012 loss in 1H 2023). Revenue: AU$1.86m (up 85% from 1H 2023). Net loss: AU$2.41m (loss narrowed 2.6% from 1H 2023). Recent Insider Transactions Derivative • Nov 29
Co-Founder & Non-Executive Director exercised options to buy AU$212k worth of stock. On the 23rd of November, Ronald Phillips exercised options to buy 2m shares at a strike price of around AU$0.057, costing a total of AU$116k. This transaction amounted to 8.0% of their direct individual holding at the time of the trade. Since June 2023, Ronald has owned 25.36m shares directly. Company insiders have collectively bought AU$187k more than they sold, via options and on-market transactions, in the last 12 months. Ankündigung • Nov 27
BCAL Diagnostics Limited has completed a Follow-on Equity Offering in the amount of AUD 2.4 million. BCAL Diagnostics Limited has completed a Follow-on Equity Offering in the amount of AUD 2.4 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 23,500,000
Price\Range: AUD 0.1
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 500,000
Price\Range: AUD 0.1
Transaction Features: Subsequent Direct Listing Ankündigung • Oct 05
BCAL Diagnostics Limited, Annual General Meeting, Nov 22, 2023 BCAL Diagnostics Limited, Annual General Meeting, Nov 22, 2023, at 10:00 AUS Eastern Standard Time. Agenda: To consider directors election. Reported Earnings • Oct 03
Full year 2023 earnings released: AU$0.024 loss per share (vs AU$0.017 loss in FY 2022) Full year 2023 results: AU$0.024 loss per share (further deteriorated from AU$0.017 loss in FY 2022). Revenue: AU$2.85m (up 297% from FY 2022). Net loss: AU$5.06m (loss widened 50% from FY 2022). Ankündigung • Sep 06
Bcal Diagnostics Limited Appoints Shane Ryan as Chief Operating Officer Effective 21 September 2023 BCAL Diagnostics Limited announced the appointment of Mr. Shane Ryan as Chief Operating Officer (COO), effective 21 September 2023. Shane will be responsible for the overall operation and administration of BCAL's clinical affairs, physician relationships, clinical product marketing, promotion, strategy, and business development. Before joining BCAL, Shane was most recently the Global Senior Vice President Strategy & Innovation - Patient Access for GenesisCare. Shane has more than 20 years' experience in the global oncology market and in particular breast cancer. He has an extensive Oncology network and deep understanding of what is critically important to both cancer patients, their treating Oncologist, and the extended multidisciplinary team. His experience covers patient care, research, innovative service delivery models, and commercial aspects of cancer patient management. Shane was also responsible for the introduction of the highly successful precision medicine test for Ductal Carcinoma In-situ (DCISionRT), providing access for Australian women for the first time in addition to this 1500 Nation-wide clinical registry. Shane has also originated other clinical trials and evaluations of predictive and management tools for the management of high-risk breast cancer patients in Australia. Prior to joining GenesisCare, Mr. Ryan spent 10 years with globally recognised Peter MacCallum Cancer Centre where he held Executive positions in Clinical Operations, Services Development and Surgery. New Risk • Sep 02
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 12% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-AU$6.4m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 48% per year over the past 5 years. Minor Risks Shareholders have been diluted in the past year (12% increase in shares outstanding). Revenue is less than US$5m (AU$2.9m revenue, or US$1.8m). Market cap is less than US$100m (AU$24.9m market cap, or US$16.0m). Reported Earnings • Aug 31
Full year 2023 earnings released: AU$0.024 loss per share (vs AU$0.017 loss in FY 2022) Full year 2023 results: AU$0.024 loss per share (further deteriorated from AU$0.017 loss in FY 2022). Revenue: AU$2.85m (up 297% from FY 2022). Net loss: AU$5.06m (loss widened 50% from FY 2022). New Risk • Aug 27
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended December 2022. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings have declined by 51% per year over the past 5 years. Revenue is less than US$1m (AU$1.3m revenue, or US$844k). Minor Risks Latest financial reports are more than 6 months old (reported December 2022 fiscal period end). Shareholders have been diluted in the past year (2.4% increase in shares outstanding). Market cap is less than US$100m (AU$24.4m market cap, or US$15.7m). New Risk • Aug 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of Australian stocks, typically moving 21% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (21% average weekly change). Earnings have declined by 51% per year over the past 5 years. Revenue is less than US$1m (AU$1.3m revenue, or US$862k). Minor Risks Shareholders have been diluted in the past year (2.8% increase in shares outstanding). Market cap is less than US$100m (AU$25.6m market cap, or US$16.7m). New Risk • Jun 30
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: AU$14.9m (US$9.84m) This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Earnings have declined by 51% per year over the past 5 years. Revenue is less than US$1m (AU$1.3m revenue, or US$872k). Market cap is less than US$10m (AU$14.9m market cap, or US$9.84m). Minor Risk Shareholders have been diluted in the past year (2.3% increase in shares outstanding). Reported Earnings • Feb 24
First half 2023 earnings released: AU$0.012 loss per share (vs AU$0.006 loss in 1H 2022) First half 2023 results: AU$0.012 loss per share (further deteriorated from AU$0.006 loss in 1H 2022). Revenue: AU$1.01m (up 146% from 1H 2022). Net loss: AU$2.47m (loss widened 88% from 1H 2022). Board Change • Nov 16
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. 2 highly experienced directors. Co-Founder & Non-Executive Director Ron Phillips is the most experienced director on the board, commencing their role in 2010. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Ankündigung • Oct 29
BCAL Diagnostics Limited, Annual General Meeting, Nov 29, 2022 BCAL Diagnostics Limited, Annual General Meeting, Nov 29, 2022, at 15:00 AUS Eastern Standard Time. Location: Mills Oakley Level 7 151 Clarence Street Sydney NSW 2000 Sydney Nsw 2000 Australia Agenda: To consider remuneration report; to consider re-election of director; to consider ratification of prior issue of shares; and to consider approval of additional 10% of issuance capacity. Reported Earnings • Aug 31
Full year 2022 earnings released: AU$0.017 loss per share (vs AU$0.011 loss in FY 2021) Full year 2022 results: AU$0.017 loss per share (down from AU$0.011 loss in FY 2021). Net loss: AU$3.39m (loss widened 122% from FY 2021). Board Change • Apr 27
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. 2 highly experienced directors. Co-Founder & Non-Executive Director Ron Phillips is the most experienced director on the board, commencing their role in 2010. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Board Change • Apr 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 3 experienced directors. 2 highly experienced directors. Co-Founder & Non-Executive Director Ron Phillips is the most experienced director on the board, commencing their role in 2010. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Reported Earnings • Feb 21
First half 2022 earnings: Revenues and EPS in line with analyst expectations First half 2022 results: AU$0.006 loss per share (down from AU$0.002 loss in 1H 2021). Net loss: AU$1.32m (loss widened 438% from 1H 2021). Revenue was in line with analyst estimates. Ankündigung • Feb 09
Bcal Diagnostics Limited Provides Additional Information on Recent Analysis to Distinguish Between Blood Samples of Breast Cancer Patients and Normal Control Samples Bcal Diagnostics Limited provided additional information to supplement the announcement dated 7 February 2022, following analysis of its scientific data carried out independently by its Australian team and by a highly regarded team of international diagnostic experts. BCAL Diagnostics provided scientific data on Cohorts 1, 2, 3, and 4, to be independently reviewed and retrospectively analysed in a strategic collaboration with BSC-Medical from the United States, involving Dr Szilard Voros, and Dr Aruna Bansal. Both experts have a proven track record in developing IVDs. BSC analysed the data in a blinded fashion, without any access to prior in-house results. In this formal analysis conducted pursuant to a pre-specified Statistical Analysis Plan, candidate signatures were developed for five discovery sets. Overall, twelve lipids selected, with two lipids selected multiple times: lipid 1 and lipid 2. Each candidate signature contained one or both of these lipids, and each candidate signature was supported by Area Under the Curve (AUC) > 70% in at least one other dataset. Two specific signatures developed for cohort 4 and combined cohorts 2+3+4 showed strong performance in the validations sets. To clarify, the cohort 4 signature was well supported by cohorts 2 and 3 with impressive AUC of 78% and 85% respectively. The cohort 2+3+4 signature was well supported by the 2+3+4 validation set with AUC of 83%. Acknowledging that the patients overlapped, these two signatures were very similar in composition, had only three lipids each, and two of the lipids were consistent, with a third lipid for each signature from one class of lipids. The supportive lipids were highly correlated. The findings demonstrated strikingly internally consistent results across all datasets. An overall accuracy of 77% was achieved in independent validation. The results are especially exciting because when testing a signature on a never seen before data set, a considerable drop in performance (15-20% based on empirical testing) from training to testing sets is frequently observed while the algorithm is being developed and fine-tuned, which was not the case here for cohort 4 and the combined cohort 2+3+4 results. This lends itself to the strength of the identified signatures. An in-house comparison of the 12 lipids identified by Dr Bansal to BCAL's results showed a 50% overlap despite the use of very different approaches. Furthermore, the 2 lipids in the most promising signatures identified by Bansal are part of BCAL's 18 lipid panel and 2 of the 12 are part of BCAL's locally optimised 6- lipid signature. This is a significant outcome given that the 12 lipids were identified out of 400+ candidates and half of them were mutually identified. In summary, the outcome of the analysis by the two teams is that a considerably reduced number of markers, compared with previous information, can be used to distinguish between blood samples of breast cancer patients and normal control samples. Such a reduction in the number of markers to be examined for each test considerably improves its commercial feasibility and attractiveness, reducing the time, cost and difficulty of analysis of each sample. Ankündigung • Feb 08
Bcal Diagnostics Limited Announces Recent Analysis Significantly Improves Commercial Prospects BCAL Diagnostics Limited reported recent results of analysis of its scientific data carried out independently by its Australian team and by a highly regarded team of international diagnostic experts. The outcome of the analysis by the two teams is that a considerably reduced number of markers, compared with previous information, can be used to distinguish between blood samples of breast cancer patients and normal control samples. BCAL is developing a blood-based test for detection of breast cancer in its early stages. The test is based on disease-associated changes in the profile of lipids (fats) found in blood. As described in the Prospectus for its 2021 IPO, the Company had at that time collected information on blood samples from 3 cohorts of women diagnosed with breast cancer compared with healthy controls. As a result, a panel of 18 different lipids, differing in their amounts between cancer and non-cancer blood samples, had been identified. Over the past 6 months, samples from a 4th cohort of patients have been examined, bringing the total of samples analysed in Australia since 2018 to 790. Examination of the data from the 4th cohort by the Company's Australian team indicated that a signature with a reduced number of lipid markers than the original 18, as few as 6 to 10, might be sufficient for an effective clinical test. Such a reduction in the number of markers to be examined for each test considerably improves its commercial feasibility and attractiveness, reducing the time, cost and difficulty for analysis of each sample. Independently, BCAL contracted a third party to review the BCAL data and perform a retrospective analysis for the entire 790 samples collected. The review identified five small lipid signatures, with two particularly strong signatures whose performance strongly characterised samples from breast cancer patients when compared with normal controls. These signatures delivered strikingly consistent performance and are in agreement with BCAL's local blind testing findings. The combination of these local and international analyses supports BCAL's goal of reaching a refined algorithm, facilitating acceleration of test development in a format that will be attractive both clinically and commercially. In addition, this greater refinement of the lipid marker panel has opened up the opportunity for BCAL to secure additional patent protection for its test. Reported Earnings • Sep 06
Full year 2021 earnings released: AU$0.011 loss per share (vs AU$0.006 loss in FY 2020) Full year 2021 results: Net loss: AU$1.52m (loss widened 119% from FY 2020). Ankündigung • Sep 03
BCAL Diagnostics Limited Commences Collecting Samples for the First Stage of Its Australian Clinical Program BCAL Diagnostics Limited announced that it has commenced collecting samples for the first stage of its Australian clinical program, to be used for validation and performance evaluation of its blood-based test for detection of breast cancer. In the first instance the test is being trialled for use as an adjunct to mammography, to help improve the accuracy of this commonly used diagnostic approach. This trial will confirm the set of candidate markers used in its breast cancer diagnostic test to distinguish between healthy women and those affected with breast cancer, as well as informing the design of the following pivotal clinical trial which will underpin regulatory approval.