IGARTM enhances Precision & Accuracy for Early Detection of Breast Cancer
Already having approached and received feedback from US FDA with a 510K pre-submission, IGAR TM -Image Guided Automated Robot, is the company’s lead product platform.
IGARTM acts under MR-guidance to execute a clinician-prepared, careful pre-planned, set of clinical functions in a tightly-confined MRI, to maximize accuracy and precision of biopsy, and prepare for related minimally-invasive interventions.
IGARTM Clinical Trial Progress
Under Health Canada ITA regulatory governance, after a successful Phase I clinical trial, subsequently a dual arm multi-site Phase II clinical trial has also been concluded. In the comparative study 21 patients had a successful IGAR biopsy, with 20 having a manual biopsy. Results from these trials show that IGAR-Breast is capable of safely, accurately and effectively working in an MRI environment.
IGAR is being developed with benefits to the patient, the physician, and the healthcare system as a priority. The ability for pre-operative programming, coupled with the critical flexibility to manage real-time in-bore micro-adjustments, also introduces the option for tele-operability, which addresses the accessibility challenges for patients living in remote locations.
High-risk BRCA & MRI importance
For women considered to have dense breasts, a known family history of breast cancer, and genetic diagnostic testing for BRCA mutations, X-ray mammography is considered by many as clinically deficient. Contrast-enhanced MR-Imaging is recommended as the diagnostic imaging modality.
In 2007 the American Cancer Society recommended an annual MRI for women with an estimated life-time breast cancer risk of 20-25% (Saslow et al., 2007). One systematic review indicated that the sensitivity range of MRI and mammography in high-risk women was 93-100%, much greater than assessing by mammography alone (Lord et al., 2007).
Seeing is not the same as diagnosing, and so the adoption of MRI-guided techniques, including needle-localization biopsy and vacuum-assisted breast biopsy are offered at many facilities in the U.S. and around the world. In fact, obtaining accreditation for MRI breast imaging requires either the ability to do MRI-guided biopsies, or a referral to a center that does.