Quantech prepares to launch cardiac test panel:
This article was originally published in Clinica
Executive Summary
Quantech has submitted a 510(k) clearance application to the FDA for a test of the cardiac marker CK-MB. CK-MB is one of three human proteins that are considered to be definitive diagnostic markers for heart attack. The others are myoglobin - for which the company already sells a test - and troponin I. St Paul, Minnesota-based Quantech plans to launch a cardiac test panel for all three proteins for its DBx rapid diagnostic system. The system consists of a table-top instrument and disposable biosensers that use the company's Surface Plasmon Resonance (SPR) technology.