FDA Grants Breakthrough Device Designation to Precision-GI for Tumor Biopsies

The FDA has granted breakthrough device designation to Precision-GI, a tool that assists with performing a tumor biopsy.

The FDA has granted breakthrough device designation to Precision-GI™ Endoscopic Ultrasound Biopsy Product, a tool that assists with performing a tumor biopsy, according to a press release by Limaca Medical.

"Precision-GI is an automated, motorized endoscopic biopsy product that has the potential to improve our biopsy results for the evaluation of gastrointestinal malignancies. Endoscopic biopsy is a highly specialized, high-skill procedure. We welcome the innovation of Precision-GI™ which can provide automation and standardization of outcomes with less variation from operator to operator," stated Seth A. Gross, MD, clinical chief, Division of Gastroenterology and Hepatology, NYU Langone Health. "Our field is driving toward patient-centric individualized cancer therapy, known as Precision Medicine, which requires consistently high quality and quantity of endoscopic biopsy tissue, enabling optimal matching of the tumor's genetic profile to personalize a patient's treatment plan."

Precision-GI works by collecting tumor tissue from within or adjacent to the gastrointestinal tract with the aid of an ultrasound visualization endoscope. Locations of gastrointestinal tumors may include submucosal lesions, mediastinal masses, lymph nodes, intraperitoneal masses, as well as other organs like the pancreas and the liver.

Manual hand operation is required to use the fine needle biopsy devices that are currently available for tumor biopsies. Precision-GI is motorized and automated. The device has a rotational cutting needle designed for tissue acquisition. Further, the developer states that the device's quality is superior to existing platforms, which can cause sample tissue fragmentation, collect inadequate amounts of tissue, and contaminate the patient’s blood.

In a feasibility study, Precision-GI was shown to obtain contiguous intact core tissue samples that appeared to be fully useful for the definitive diagnosis of pancreatic lesions. Moreover, the tissue samples obtained with the device in the study have a high percentage of tumor content with little blood and extraneous fluids.

"We are pleased with the FDA's decision to grant the Breakthrough Device Designation to Precision-GI," stated Carl Rickenbaugh, the chief executive officer of Limaca, in a statement. "At Limaca, our vision is to ensure that endoscopic biopsies always achieve a definitive diagnosis to enable optimal and timely GI-cancer treatment. We are dedicated to the mission to provide a far better endoscopic biopsy experience for the endoscopist and patient, with the goal to achieve a faster, more efficient biopsy yield with highly consistent results. With the breakthrough device designation, we look forward to accelerating our progress toward our goal of obtaining the FDA's 510(k) clearance to bring Precision-GI to patients in the US in the near future."

REFERENCES:

Limaca Medical receives FDA breakthrough device designation USA – English. News release. May 02, 2022. Accessed May 03, 2022. https://prn.to/3ybWVEP