FDA BRIEF: Week of October 2, 2017


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COBAS ZIKA Test

Roche Molecular Systems, Inc.

INTENDED USE: Qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in human plasma. Intended for use to screen donor samples for Zika virus RNA in plasma samples from individual human donors, including donors of whole blood and blood components, and other living donors.

Also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors should be screened as individual samples.

Not intended for use as an aid in diagnosis of Zika virus infection, on samples of other body fluids, on samples of cord blood.

ADDRESSING UNMET NEED:

  •  First approval of a Zika virus detection test for use with screening the nation’s  blood supply
  • Critical to preventing infected donations from entering the U.S. blood supply

REGULATORY PATHWAY: BLA

  • Collaboration between FDA, manufacturer and blood collection industry
    • 2016 FDA guidance recommending screening whole blood and components with cobas Zika test available under IND
    • Several blood collection establishments used test providing data
    • Additional studies by manufacturer to demonstrate effectiveness

TEST DESCRIPTION:

  • Fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection
  • For use on the fully automated cobas 6800 and cobas 8800 systems
  • Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module
  • Automated data management is performed by software which assigns test results for all tests as non-reactive, reactive, or invalid
  • Results reviewed directly on system screen and printed as report

CLINICAL PERFORMANCE:

  • Reproducibility: Testing twelve member panel of three negative plasma samples and three positive;  reproducible performance across variables assessed for detecting Zika
  • Specificity: Testing individual samples from blood donations (n= 358,038 ) at five external laboratories;  clinical specificity was 99.997%
  • Sensitivity: Using 25 confirmed Zika-positive clinical samples at an internal testing site; detected 100%

PACKAGE INSERT


the-remede-system-productRemedē System

Respicardia Inc.

USE:  Implantable stimulation device designed to improve cardiovascular health by  restoring natural breathing at night.

Includes wires for sensing and stimulation, a neurostimulation device, and a portable tablet programmer.

Designed to replace inappropriate signal from the brain that delivers electrical pulses at night, during sleep, to restore a more normal breathing pattern and improve  cardiovascular health in patients with Central Sleep Apnea

ADDRESSING UNMET NEED: 

  • Central sleep apnea can lead to poor sleep quality and may result in increased risk for high blood pressure, heart attack, heart failure, stroke, obesity, and diabetes
  • Implantable device offers patients another treatment option for central sleep apnea

REGULATORY PATHWAY: PMA

DESCRIPTION:

  • Battery pack surgically placed under the skin in the upper chest area
  • Small, thin wires inserted into blood vessels in chest near phrenic nerve that stimulates breathing
  • System monitors patient’s respiratory signals during sleep, delivers a small electrical stimulus to phrenic to move diaphragm and restore normal breathing
  • Has 2 modes – generate pulses at a fixed rate (asynchronous therapy) or deliver a pulse only when it detects a pause in breathing (synchronous therapy)
  • Physician sets stimulator to deliver most appropriate therapy
  • Has safeguards to make sure that therapy is only delivered during sleep

EFFECTIVENESS AND SAFETY:

  • Study on 141 patients to assess reduction in apnea hypopnea index (AHI), a measure of the frequency and severity of apnea episodes, after 6 months
  • Reduced by 50%  or more in 51% patients vs. 11% reduction with in patients without the system
  • Most common adverse events: Concomitant device interaction, implant site infection, swelling and local tissue damage or pocket erosion

Image credits: Roche, Respicardia

 

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