Validation Trial

The Bio Farmag validation trial has been completed. The 2,000 patient validation trial commenced in 2007 supported by major radiology and diagnostic groups.

The trial involved Australian women who have been referred to radiologists by their GP for a mammogram. The results from the Bio Farmag Test were compared to current screening methods of mammography and ultrasound (and any subsequent biopsy & pathology results).

May Results

In May 2008, the results of 2,000 patients were released. The outcome confirms that the Bio Farmag Test will offer an effective and non-invasive addition to current breast cancer screening options.

Validation phase and trial outcomes include:

  • Overall accuracy level of the Bio Farmag Test in the 2,000 patient trial was 69% (75% after exclusion of damaged hair)
  • Correct diagnosis of almost 1,500 women as negative for breast cancer and 20 patients correctly as positive for breast cancer
  • Correctly identified as negative for breast cancer 80 per cent of patients referred for a biopsy as a result of mammography. This highlights the potential value of the test in conjunction with current screening methods
  • 13 patients found to be positive for breast cancer by a mammogram and biopsy were missed by the Bio Farmag test. This is believed to be due to damage to hair from treatments not identified by fluorescence screening and/or biological variation. The accuracy of the test can be affected by hair treatments such as perming, dyeing and straightening, which can be overcome in most cases by using new growth of the hair (approximately 4 weeks required)
  • The accuracy of the test in a commercial use is expected to significantly improve as women will prepare for the test by ensuring they have undamaged new growth of hair for testing. During the trial this could not take place as patients had no advance notice of the test and the requirements
  • The value of the test for women of all ages was confirmed with patients covering a wider age group than current screening recommendations