Translational Sciences Corporation Receives FDA 510(k) Clearance For Commercialization Of OncoTrac™ In The United States

Translational Sciences Corporation (TSC) announced 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™.

Article adapted by Medical News Today from original press release. Source: Translational Sciences Corporation
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