Almen Laboratories, Inc.
Almen Laboratories has developed a sophisticated software system for imaging applications that provides extensive tools to identify objects and image features of interest, analyze the information content and then store, retrieve and compare different objects and images of interest based on this information.
Situation
In current medical practice, breast biopsy serves as the gold standard for determining if a breast mass is benign or malignant. Mammography is the main imaging procedure (screening) for detecting suspicious findings with its high sensitivity but its lower specificity (False Positives) is well documented. With increased emphasis on early detection of breast cancer, it appears the effort to avoid missing a malignant lesion may have led to a low positive biopsy rate for cancer, between 10-31%. Unfortunately, breast biopsy is neither a benign nor an inexpensive process. Besides affecting patients physically and emotionally, the procedure frequently causes internal scarring, which may obscure the results of future mammograms. With approximately 1,700,000 women undergoing breast biopsy per year in the USA, combined with a cost between $750-5000 per procedure, the cost to the U.S. healthcare system is very significant.
Solution
Ultrasound is widely regarded as the adjunct (secondary) procedure of choice to mammography, especially for distinguishing cystic from solid masses in which accuracy is 96-100%.
Almen Laboratories has developed a sophisticated software system for imaging applications that provides extensive tools to identify objects and image features of interest, analyze the information content and then store, retrieve and compare different objects and images of interest based on this information. During last 7 years and in collaboration with luminary clinical sites this software system was tailored to the needs of diagnostic breast ultrasound.
The implemented Computer-Aided Diagnostic system (CAD) was validated on Institutional Review Board approved cohort of cases with available confirmation of the “truth” via needle biopsy or 12 months follow-up for non-suspicious benign lesions. The completed product improves accuracy of practitioners, potentially increasing their confidence in breast ultrasound, reduce variability of interpretations, and increase ultrasound’s role in breast cancer detection and management. The novel solution also increases transparency and clarity of healthcare decision-making and offers patients understanding of the practitioners’ rationale on a right-to-know basis.
Better Health and Lower Costs
Results suggest that more accurate application of BIRADS assessment for diagnostic ultrasound could in future help reduce the number of biopsies by 40% with a cost savings of well over $1 billion per year in the USA, mainly by reducing the number of False Positives. In a variety of clinical studies the completed computer-aided diagnostic software solution increased in average by 5-10% accuracy of diagnostic decision-making of the specialty radiologists.
During those clinical validations it was also discovered that the CAD solution developed by Almen Laboratories can be populated into other modalities such as screening mammography and diagnostic breast MRI. Such combination of clustering computer-aided tools promises to increase overall healthcare savings by additional 20%.
