Device enables decentralized blood sample collection and plasma separation using company’s Torq Zero Delay Centrifuge System
PLEASANTON, CA, USA, March 25, 2020 /EINPresswire.com/ — Sandstone, a healthcare tools company enabling access to lab testing anywhere and anytime, announced today that the company has submitted an application to the U.S. Food and Drug Administration (FDA) for 510(k) clearance of its Torq ZDisc Lithium Heparin device. The ZDisc is a novel disc-shaped blood collection device that separates blood cells from liquid plasma at the point of collection using the Torq ZDrive – a 4-inch diameter battery-powered centrifuge device.
The uniquely portable Torq System is designed for decentralized blood sample collection and stabilization applications, such as point-of-care and at-home blood draws, where access to conventional centrifuges and other laboratory equipment is impossible. Stabilizing blood specimens immediately at the point of collection improves both the purity and stability of the sample, ensuring higher quality and reliability for clinical diagnostic tests.
In clinical evaluations, Sandstone’s ZDisc shows superior sample quality metrics, such as reduced hemolysis and cellular contamination, compared to conventional blood collection methods. Sandstone has also demonstrated compatibility with most major classes of plasma analytes in head-to-head method comparison studies, with further clinical evaluations planned soon.
“We are committed to improving access to lab testing and patient monitoring, which has never been more important than it is during the current COVID-19 outbreak,” said Sandstone’s CEO Karen Drexler. “As healthcare rapidly shifts toward decentralized and virtual care models, Torq is an enabling tool to ensure patients have access to high quality laboratory diagnostics anywhere, and anytime.”
Current Torq customers include Clinical Research Organizations (CROs) and mobile phlebotomists. The technology is also in evaluation with clinical labs, pharmaceutical developers, and novel test developers including liquid biopsy providers. With FDA 510(k) clearance pending, Sandstone aims to expand commercial opportunities across various healthcare and life science research segments currently hindered by conventional blood acquisition options.
“Nearly 75% of all medical decisions are based on laboratory diagnostic results,” continued Ms. Drexler. “There is a tremendous need to expedite diagnostic workflows to improve access, efficiency, and cost of healthcare delivery. We are thrilled to be providing a novel and much needed tool in this effort.”
About Sandstone Diagnostics
Founded in 2012 in part by government scientists from Sandia National Laboratories, Sandstone’s mission is to make high quality lab testing ubiquitous by bringing powerful, portable CentriFluidic™ Technology to the point of care. Learn more at sandstonedx.com.
Torq Zero Delay Centrifuge System
Source: EIN Presswire