BEERSE, Belgium, June 1, 2016 /PRNewswire/ -- As part of
Johnson & Johnson's commitment to combat Ebola, Janssen
Pharmaceutica NV today announced that the Idylla™ Ebola Virus
Triage Test (Idylla™ EBOV Test) was granted Emergency Use
Authorization (EUA) by the U.S. Food and Drug Administration
(FDA)1. The Idylla™ Ebola Virus Triage Test is a
diagnostic that detects the presence of the Ebola Zaire virus in
patients with signs and symptoms of Ebola virus disease and was
jointly developed by Janssen Diagnostics, a division of Janssen
Pharmaceutica, Biocartis NV (Biocartis), and the Belgium
Institute of Tropical Medicine.
The 2014 Ebola virus outbreak in West
Africa was the largest outbreak since its discovery 40 years
ago. With over 11,000 deaths reported2 and affecting
multiple countries, that outbreak demonstrated a clear need for
improved infectious disease surveillance and management. Today,
further preparation is needed, as specialists2 expect
sporadic Ebola virus outbreaks to continue in the future.
The Idylla™ Ebola Virus Triage Test is a real-time reverse
transcription polymerase chain reaction (rRT–PCR) test intended for
the qualitative detection of RNA from the Ebola Zaire virus
(detected in the West Africa
outbreak in 2014) in EDTA venous whole blood from individuals with
signs and symptoms of Ebola virus infection in conjunction with
epidemiological risk factors. The blood sample is placed into
a sealed cartridge and requires no further manipulation of
potentially infected blood. After processing, the outside of
the cartridge can be decontaminated prior to disposal. Results are
delivered within 100 minutes. The Idylla™ Ebola Virus Triage Test
does not require cold chain reagent storage. It is highly
standardized, automated, and requires minimal training to interpret
the results.
"We are very pleased that the FDA has granted Emergency Use
Authorization for the Idylla™ Ebola Virus Triage Test," commented
Jorge Villacian, M.D., Chief Medical
Officer, Janssen Diagnostics.
"Across Johnson & Johnson, we are mobilizing our resources and
expertise to help prevent another outbreak of Ebola."
Intended Use
The Idylla™ Ebola Virus Triage Test is a real-time reverse
transcription polymerase chain reaction (rRT –PCR) test intended
for the qualitative detection of RNA from the Ebola Zaire virus
(detected in the West Africa
outbreak in 2014), in EDTA venous whole blood from individuals with
signs and symptoms of Ebola virus infection in conjunction with
epidemiological risk factors.
Testing with the Idylla™ Ebola Virus Triage Test should not be
performed unless the patient meets clinical and epidemiologic
criteria for testing suspect specimens.
Results are for the presumptive identification of Ebola virus
RNA. The definitive identification of Ebola virus RNA requires
additional testing and confirmation procedures in consultation with
public health or other authorities for whom reporting is required.
The diagnosis of Ebola virus infection must be made based on
history, signs, symptoms, exposure likelihood, and other laboratory
evidence in addition to the identification of Ebola virus RNA.
Negative results do not preclude Ebola virus infection and should
not be used as the sole basis for patient management decisions.
The level of the Ebola virus that would be present in blood from
individuals with early systemic infection is unknown. Due to the
difficulty in obtaining clinical specimens positive for Ebola, the
Idylla™ Ebola Virus Triage Test was evaluated with limited numbers
of contrived specimens spiked with live Ebola Zaire virus RNA. The
Test has not been evaluated with blood from individuals with Ebola
Zaire virus infection.
The Idylla™ Ebola Virus Triage Test is for use only under
Emergency Use Authorization (EUA) by laboratories in the United States certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a,
to perform moderate complexity tests, and by laboratories in
the United States certified under
CLIA to perform high complexity tests, or in similarly qualified
non-U.S. laboratories, by clinical laboratory personnel who have
received specific training on the use of the Idylla™ Ebola Virus
Triage Test on the Idylla™ System.
Notification of Public Health authorities: local, state and
national public health agencies (for example, county and state
health departments or the U.S. Centers for Disease Control and
Prevention (CDC)) should be notified of any patient suspected to
have Ebola Virus Disease (EVD). Confirmatory testing at the
state/local public health laboratory or at CDC is necessary for
positive detection results and may be necessary for negative
detection results. Laboratories should consult with local, state or
national public health officials on any positive or negative EBOV
Test result on the need for additional testing and appropriate
transportation of specimens.
Our Commitment to Global Public Health
For 130
years, Johnson & Johnson has been committed to improving the
health of individuals, families and communities around the world,
including the most vulnerable populations. Today, our vibrant,
entrepreneurial and committed employees bring business acumen and
their collaborative spirit to help solve some of the most complex
global health problems. By harnessing our collective breadth and
scale, and our employees' passion and purpose, we strive to advance
health care and positively impact the lives of all
people.
About the Janssen Pharmaceutical Companies
At the
Janssen Pharmaceutical Companies of Johnson & Johnson, we are
working to create a world without disease. Transforming lives by
finding new and better ways to prevent, intercept, treat and cure
disease inspires us. We bring together the best minds and pursue
the most promising science. We are Janssen. We collaborate with the
world for the health of everyone in it. Learn more at
www.janssen.com. Follow us at @JanssenGlobal or
@JNJGlobalHealth.
1 An application for the test, the Idylla™ Ebola
Virus Triage Test, was submitted for Emergency Use Authorization to
the FDA by Janssen Diagnostics' partner, Biocartis NV.
2 Centers for Disease Control (CDC) Case Counts,
updated 13 April 2016:
http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/
Press Contact:
Frederik Wittock
+32 14 60 57 24
fwittock@its.jnj.com
Investor Contacts:
Louise Mehrotra
+1 (732) 524-6491
Lesley Fishman
+1 (732) 524-3922
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SOURCE Janssen Pharmaceutica NV