2017
Limaca Medical has developed a game-changer in endoscopic ultrasound-guided biopsy for precision medicine. its Precision-GI™ Endoscopic Ultrasound Biopsy Product received a Breakthrough Device Designation from the U.S. Food and Drug Administration.
Precision™, developed by Limaca, is an endoscopic ultrasound (EUS) guided biopsy device for improved diagnosis of the gastrointestinal system and adjacent organ tumors. The device samples high-quality core-tissue for precise analysis and diagnostic accuracy to provide patient-specific treatment and improved clinical outcomes.
Cancer treatment is rapidly advancing towards precision medicine. By analyzing an individual’s cancer cells, genetic profiling is used to identify genomic defects and to tailor precise treatment to the individual patient. Limaca’s first steps in precision medicine are in the field of pancreatic cancer.
Pancreatic cancer is a deadly cancer with a low survival rate of 9% only, the lowest of all cancers. Current methods used for EUS biopsy are manual stabbing devices that provide tissue samples that are inadequate for genetic profiling. Current manual needles require “stabbing” the lesion over twenty times to acquire tissue samples that are adequate for cytological (cell) analysis only and inadequate for advanced patient-specific genetic profiling analysis. According to The Pancreatic Cancer Action Network (PanCAN), there is an urgent need for every pancreatic cancer patient to get tested through a genetic profiling platform. Furthermore, the National Comprehensive Cancer Network (NCCN) guidelines state that every patient with pancreatic cancer should get genetic profiling testing.