The objective of this study was to investigate the efficacy of melding three emerging
technologies: Pharmacogenomics, Modified Military Digital Infrared and Halo to establish their capability in
diagnosing ultra-small breast cancers as well as other cancers. Mammography, ultrasound and MRI
technologies have been available for over forty years, however, there is still no uniform utilization by women,
costs continue to escalate and problems persist like high false positive rates for MRI and high false negative
rates for mammography.
Of the first 500 IR patients, 499 were female and 1 male. Of 550 OncoVue patients, 129 opted to undergo IR. A
total of 19 were lost to follow-up. Patients who were negative on IR: 419/500 (84%). Of these, 63/419 went to
biopsy because of findings of other diagnostic modalities.
Of these 61/63 with negative IR had a negative biopsy. Of two missed, one was the fault of the investigator but
was included. In this series 2/500 were false negative (0.4%). The sensitivity was 96% and the specificity was
79%. In total, 46 cancers were identified including five outside the breast (e.g. 2 lung cancers). A total of 92
MRIs were done and in 71/92 patients IR and MRI agreed. Using these three modalities the smallest cancer
found was a 4 mm invasive cancer.
The study demonstrated that these diagnostic techniques can dramatically lower cost and provide results at
least as good as the older paradigms. Further research and a multicenter clinical trial are necessary to shift the
paradigm of breast cancer diagnosis and treatment.