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• Diagnostics
  

  New Test Diagnoses Lyme Disease Within 15 Minutes

  Rapid diagnostic test for Lyme disease matches and outperforms standard testing approaches; could be used in a clinician's office.

  Columbia University School of Engineering and Applied Science 10.11.19
  

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• Diagnostics
  

  Blood Test May Help Accelerate Brain Cancer Diagnosis

  Could improve patient quality of life and survival.

  University of Strathclyde 10.09.19
  

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• Diagnostics
  

  LAM's Liquid Biopsy Liver Cancer Detection Test Wins Breakthrough Status

  Blood-based liquid biopsy test analyzes DNA methylation pattern of cell-free DNA (cfDNA), indicating presence of hepatocellular carcinoma as early as Stage I.

  PR Newswire 09.03.19
  

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• Diagnostics | Patient Monitoring
  

  FDA OKs Drawbridge Health's OneDraw A1C Test System

  The small, single-use device draws, collects, and stabilizes a capillary blood sample from the upper arm to measure HbA1c levels.

  PR Newswire 08.22.19
  

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• Diagnostics
  

  New TB Blood Test May Also Identify People at Most Risk

  The new Actiphage blood test offers the potential to target those at risk of TB and allow treatment to start early.

  National Institute for Health Research 07.10.19
  

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• Diagnostics | Neurological
  

  FDA Awards Breakthrough Status to Blood Test to Determine Alzheimer's Risk

  Breakthrough Device Designation granted to C2N’s proprietary blood test for the initial screening of amyloid pathology in the brain associated with Alzheimer's.

  Business Wire 01.29.19
  

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• Diagnostics
  

  Fully Automated BD Phoenix CPO Detect Test Receives FDA Clearance

  New test helps hospitals more quickly identify and treat emerging antibiotic-resistant bacteria.

  PR Newswire 01.08.19
  

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• Diagnostics
  

  FDA Grants Breakthrough Device Designation to Siemens Healthineers’ ELF Test

  The company is collaborating with Gilead Sciences as part of its work to seek clearance of the test.

  Siemens Healthineers 11.09.18
  

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• Diagnostics
  

  FDA OKs T2 Biosystems' Rapid Sepsis Test

  First FDA-cleared test to identify sepsis-causing bacteria direct from whole blood.

  GlobeNewswire 05.30.18
  

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• Diagnostics
  

  FDA Clears First-Ever Fentanyl Urine Drug Screening Test

  Fentanyl enzyme immunoassay brings high-performance qualitative screening to a wide range of healthcare settings.

  Immunalysis Corporation 07.31.17
  

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