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Miacom Diagnostics GmbH. (11/3/15). "Press Release: Miacom Diagnostics GmbH Gets FDA Clearance for hemoFISH Masterpanel". Düsseldorf.

Region Region United States (USA)
Organisations Organisation Miacom Diagnostics (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product hemoFISH Masterpanel
  Product 2 diagnostic test, rapid (point-of-care)
Person Person Stange, Mirko (SilverSky LifeSciences 2019045 Managing Director before Ventac Partners + Miacom Diagnostics)
     


miacom diagnostics GmbH, Duesseldorf, a company focused on the development and production of medical tests for the detection of acute infectious diseases, today announced the U.S. Food and Drug Administration (FDA) clearance for its test system for detection of bacteria directly from positive blood cultures (hemoFISH Masterpanel). This decision is a major independent validation of Miacom’s proprietary molecular beacon technology being successfully applied in the hemoFISH assays. The FDA clearance involved an extensive review of miacom diagnostics’ innovative rapid diagnostic test. Use of this test features many user benefits as it requires only minimum hardware and provides major cost savings over other available tests on the market.

hemoFISH assays have already been approved for use by the European and Canadian authorities and carry a “CE” mark. To pass the FDA’s regulatory process, miacom collected significant data in the US. With these clinical data the hemoFISH assay easily passed the FDA regulatory process. This is clear proof of the power of miacom’s proprietary technology to meet even the most demanding standards, while at the same time providing physicians with an extremely simple and rapid alternative for bacterial identification in positive blood cultures.

“We are a young company and this FDA clearance validates miacom as a strong, viable player in the rapid diagnostic field,” said Dr. Mirko Stange, the CEO of miacom diagnostics GmbH. “This milestone proves the efficiency of our technology in identifying bacteria in positive blood cultures. With the CE-marked respiFISH product line for direct detection from respiratory samples and an exiting development pipeline we have much more to offer and this is just the beginning.”


About miacom diagnostics (www.miacom-diagnostics.com)

Miacom diagnostics specializes in in vitro diagnostic tests for pathogens causing acute systemic diseases. Miacom will change critical patient care by providing rapid molecular diagnostics tools designed for routine use to promote more efficient antibiotic therapies and help healthcare organizations reduce costs. Miacom’s current “tool box” includes the world’s only molecular diagnostics (Mdx) test that identifies all relevant pneumonia-related bacteria directly from sputum in only 30 minutes as well as rapid multiplex solutions for sepsis patients.

Miacomdiagnostics GmbH:
CEO, Dr. Mirko Stange
+49-211-301-55795
m.stange@miacom-diagnostics.com

press contact:
wordstatt GmbH
• Dagmar Metzger
• info@wordstatt.de

   
Record changed: 2017-04-02

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