Translational Sciences Corporation Receives FDA 510(k) Clearance for Commercialization of OncoTrac(TM) in the United States
11/22/2011 6:46:07 AM
CAMBRIDGE, Mass., Nov. 21, 2011 /PRNewswire/ -- Translational Sciences Corporation (TSC) announced today that it has received FDA 510(k) clearance for commercialization of its OncoTrac medical imaging software. OncoTrac is designed for efficient quantitative assessment of treatment response of metastatic tumors including breast, lung, colorectal, prostate, and lymphoma. The OncoTrac family of products provides a structured workflow solution for cancer practitioners and researchers to report precise measurements of solid and metastatic tumors for routine clinical care and cancer drug trials. As a vendor-neutral platform, OncoTrac software architecture is suitable for use in daily radiology practice, and can be easily integrated into most existing Picture and Archive Communications Systems (PACS) environments without any product customization. OncoTrac will be available for demonstration at the Annual Meeting of the Radiological Symposium of North America (RSNA) in Chicago in November 2011.
OncoTrac enterprise software facilitates tumor response assessment using widely accepted standards such as RECIST 1.0, RECIST 1.1, and WHO, as well as emerging standards such as the Choi criteria. Assessments using these criteria are commonly required by clinical trial protocols and are often submitted as primary and secondary end-point data in new anti-cancer FDA drug approval applications. Yet, not all clinical cancer research reports tumor response correctly. OncoTrac is designed to assure conformity to response assessment standards and to aid compliance with established clinical research standards including FDA Good Clinical Practice (GCP) and Part 11 Electronic Medical Records.
"With OncoTrac, formal response assessment methods used in clinical trials can be efficiently implemented in routine radiological cancer evaluations in support of patient management," said Howard Pinsky, CEO of Translational Sciences Corporation. "Subject assessment data are integrated into existing research workflows, thereby providing capabilities comparable to those performed at core imaging laboratories in support of drug applications."
OncoTrac features advanced report generation capabilities that provide additional value to ordering oncologists, radiologists, and cancer patients through improved visualization of quantitative response to therapy. Reports can be exported and stored in both a PACS system and in an electronic medical record (EMR).
OncoTrac was originally developed by Mint Medical GmbH at the German Cancer Research Center (Heidelberg) and is currently in use at major cancer centers in Europe under the brand Mint Lesion.
ABOUT TRANSLATIONAL SCIENCES CORPORATION
Headquartered in Cambridge, Massachusetts, Translational Sciences Corporation (TSC) is a medical software company dedicated to adding value to medical imaging studies, increasing physician efficiency, and improving patient management.
For more information, please contact Howard Pinsky or Dr. Neil Steinmetz at:
Translational Sciences Corporation
One Mifflin Place
Cambridge, MA 02138
phone: +1 617.297.2577
fax: +1 877.219.3940
SOURCE Translational Sciences Corporation