New breakthrough test for low-resource, high-burden regions to help
in global fight against tuberculosis
QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced
that QuantiFERON®-TB Access, a new solution under development
for diagnosis of latent tuberculosis (TB) infection in low-resource
regions with a high disease burden of tuberculosis, will be recognized
by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the
organization’s Health Innovation Exchange from May 21-23 in Geneva,
Switzerland. The event will be held during the World Health Assembly and
brings together ministers of health, nonprofits and industry to
spotlight innovations with potential to change the world’s health
landscape and benefit sustainable development.
QuantiFERON-TB Access (QFT® Access) is a proprietary new test
designed to advance tuberculosis control in areas with limited
infrastructure, including countries in Asia, Africa and Latin America.
The World Health Organization (WHO) has classified 30 countries in these
regions as high-burden, representing an estimated 85% of the global TB
burden. QFT Access pairs highly sensitive digital detection with a
complete workflow created to deliver cost-efficient results quickly and
with unmatched simplicity. It eliminates the need for an extensive
laboratory infrastructure while providing best-in-class QuantiFERON
technology. Clinical trials are being conducted in 2019, and
commercialization of QFT Access is expected to begin in 2020.
“We are pleased that UNAIDS selected QuantiFERON-TB Access for
recognition at the Health Innovation Exchange. QIAGEN’s drive to develop
QFT Access springs from the need for a modern, accurate test for TB
infection screening in areas where the disease burden is high but
resources and infrastructure are scarce,” said Thierry Bernard, Senior
Vice President, Head of the Molecular Diagnostics Business Area at
QIAGEN. “QFT Access builds on the success of QuantiFERON®-TB
Gold Plus, the modern gold standard for detection of latent TB
infection. We have created a field-friendly Sample to Insight solution
using a simple test to reduce costs and labor and avoid the need for
cold chain, a computer or continuous power supply.”
QIAGEN is developing QuantiFERON-TB Access in partnership with Ellume,
an Australian developer of digitally-enabled diagnostics. QFT Access is
a single visit, single tube test using 1 ml blood test that is scalable.
It is not impacted by BCG vaccination, which can cause false-positive
results with the tuberculin skin test used in many low-resource
settings. QFT Access requires less than five minutes of hands-on time
from a technician or phlebotomist. The result can be digitally displayed
on a portable device or, optionally, connected to a computer for
printout or electronic transmission. The system does not require
maintenance or calibration, and it minimizes the impact of power loss or
dust.
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