Focus Diagnostics Home
 Home  About Focus Diagnostics  Employment  Contact Us
Support Services Vaccine Studies Testing Capabilities Contact Us
Clinical Trials Laboratory
Expertise in clinical trials supporting infectious disease prevention and treatment.

Our Credentials: Experience

  • More than 100,000 clinical trial subjects sampled
  • Trials in excess of 10,000 subjects per trial
  • All influenza vaccine strains validated over the past 5 years

Clinical Trials Support Services

  • Expertise in performing high volume testing of complex and labor intensive assays
  • Routine use of highly specialized ‘gold standard’ methods that are technically difficult to perform and reproduce
  • Established reference laboratory testing services available for specific clinical trial testing – Esoteric microbiology, virology, immunology, molecular analysis
  • Dedicated project management team
  • New assay assessment, qualification, and validation under FDA, ICH, and other applicable guidelines and regulations
  • Qualification and validation for custom-defined laboratory protocols
  • Custom-formatted test reports and connectivity to meet client specifications
  • Specimen storage, tracking and retrieval
  • Access to Quest Diagnostics’ extensive global clinical trials capabilities

Facility

  • Dedicated laboratory space
  • Fully functional BSL3 capabilities and dedicated bio-suites
  • On-site IT systems and support

First FDA Clearance of a 2009 H1N1 Test Given to Focus Diagnostics


FDA Issues Another Emergency Use Authorization for Commercial H1N1 Flu Test to Quest Diagnostics’ Focus Diagnostics


Focus Diagnostics provides the first commercial test for detecting the 2009 H1N1 influenza virus that the FDA has authorized for emergency use.


 
©2010 - Focus Diagnostics - All Rights Reserved - Site Revision ID: WEB.FOCUSDX.C3 - Privacy Policy - Site Map