Key Takeaways
- BCAL Diagnostics has introduced the BREASTEST Monitor, a new blood test aimed at detecting local breast cancer recurrence post-treatment.
- The test achieved a sensitivity of 91% and a Negative Predictive Value of 95% in preliminary findings.
- BCAL targets women over 50 and seeks further validation, with plans for commercial launch following additional studies.
New Test for Breast Cancer Monitoring
BCAL Diagnostics (ASX: BDX) has launched the BREASTEST Monitor, a novel blood test designed to evaluate local recurrence of breast cancer after treatment. This non-invasive test aims to detect the presence of recurrence in the breast, armpit, or lymph nodes, addressing a significant need in post-treatment surveillance for breast cancer patients.
Preliminary results indicate that the BREASTEST Monitor can correctly identify local recurrence in 20 out of 23 confirmed cases among women aged 50 and older. The test demonstrates a sensitivity of 91% and a Negative Predictive Value (NPV) of 95%, showcasing its potential effectiveness.
Local recurrence poses a challenge, affecting approximately 15% of women following breast cancer treatment, sometimes appearing years after initial diagnosis. Early detection is crucial, as timely intervention can significantly improve curative outcomes. Current monitoring primarily employs imaging techniques like mammography and MRI, which can be resource-intensive and sometimes less effective, particularly in women with dense breast tissue or scarring.
To develop the BREASTEST Monitor, BCAL utilized over 450 samples, applying the algorithm to a separate test set of 100 samples that included both confirmed local cancer cases and women with negative imaging results. This method ensured initial training was not biased, optimizing the algorithm’s ability to detect early-stage recurrence across various demographics.
Now, BCAL is focusing its efforts on women aged 50 and older who have undergone treatment. In the U.S., over 4 million breast cancer survivors and more than 200,000 in Australia require ongoing monitoring. The global market for breast cancer surveillance is predicted to reach $4.5 billion by 2030, indicating a substantial opportunity for BCAL’s innovations.
Further validation is necessary before commercial launch, prompting the company to seek additional breast cancer patients for studies, including those under 50. In addition to the BREASTEST Monitor, BCAL has already introduced BREASTESTplus, which assists in evaluating breast disease in women with dense breast tissue.
BCAL holds an exclusive license with ClearNote Health for several blood tests for pancreatic and ovarian cancers in Australia and New Zealand. BCAL’s CEO, Anne-Louise Arnett, called the introduction of the BREASTEST Monitor a vital clinical milestone, emphasizing the importance of addressing unmet needs in breast cancer care. Shane Ryan, Executive Manager of Clinical Affairs, highlighted the need for reassurance and ongoing support for women post-treatment through this innovative testing approach.
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