The new blood test is effectively a non-invasive biopsy that can accurately detect breast cancer in otherwise asymptomatic women. This relatively simple test could be good news for many women and have definitive advantages for breast cancer screening, well in advance of any lumps appearing. Also, for women over the age of forty, as Breast Consultant, Mr Simon Marsh explains, "cysts become the most common cause of a definite lump". These cysts are harmless, but they cause concern and an early, accurate diagnosis is clearly needed to rule out cancer.
The US Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for its blood test to detect early-stage Breast Cancer. The company say that this is the first blood test able to detect early-stage Breast Cancer with high accuracy in women above the age of 40 years.
The so-called "Breakthrough Designation" is granted by the US FDA for devices that demonstrate a potential for more effective diagnosis of life-threatening diseases such as cancer, and to expedite regulatory approval.
CTCs represent a true non-invasive micro-biopsy
The test can detect specific breast cancer Circulating Tumour Cells (CTCs) including Stage 0 (DCIS) and Stage 1 cancers with high accuracy. The test requires a blood sample and is suggested for asymptomatic women above the age of 40 years with a physician's prescription.
Worldwide more than 2.3 million women are detected with Breast Cancer each year and early detection is considered critical for cure.
Dr Vineet Datta, Director of Datar Cancer Genetics said, "We are pleased that the FDA has recognised the potential of our test for the detection of early-stage Breast Cancer. We believe that the test will offer definitive advantages for Breast Cancer screening once it receives marketing authorisation from the FDA." The Company believes that detection of CTCs is the most dependable and accurate method for early detection of cancer as it enables capture and characterisation of functional components of a tumour rather than fragments of dead cells. In that sense, CTCs represent a true non-invasive micro-biopsy.
The test is already available in Europe as 'Trucheck™' and is CE marked.
Oncologists in the UK such as Dr Andy Gaya have applauded the launch of these new early detection diagnostic biomarkers. They stress the importance of offering both drug-based and radiation-based therapies along with close liaison with surgical and interventional radiology. Andy Gaya is a leading authority on the unique combination of multiple treatment modalities and personalised tumour molecular profiling into bespoke treatment packages.
What are the symptoms of breast cancer?
Though the most common symptom of breast cancer is a lump, there are several changes that a women should look out for:
- Definite lump
- Nipple discharge
- Inverted nipples
- Dimpling of breast skin
- Rashes around the nipple (similar to eczema)
See 12 signs of breast cancer - know your lemons.