Roche receives FDA approval for the first molecular test to screen for malaria in blood donors
March 26 2024 - 11:45AM
UK Regulatory
Roche receives FDA approval for the first molecular test to screen
for malaria in blood donors
- The cobas Malaria test is
the first FDA-approved molecular test to screen U.S. blood donors
for malaria
- Malaria is a serious and
potentially fatal parasitic infection most commonly transmitted by
mosquitoes that can also be spread through blood
transfusion
- Roche is dedicated to
saving patients’ lives through diagnostic solutions that aid in the
protection of the global blood supply from infectious
diseases
Basel, 26 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the U.S. Food and Drug Administration (FDA)
approval of the cobas® Malaria test for use on the cobas® 6800/8800
Systems. This approved test can aid healthcare professionals in
reducing potential risks of patient infection from transfused blood
products. The cobas Malaria test provides a highly sensitive and
specific solution to help ensure that infected blood units are
removed from the blood supply.
The cobas Malaria molecular test screens whole blood samples for
the five main species of Plasmodium parasites that are known to
cause human infection. The potential value of a molecular donor
screening test for malaria is to improve both blood safety and
availability. The test is intended for use in screening blood,
organ and tissue donors.
“As the first FDA-approved blood screening test for malaria,
this represents an important step forward in safeguarding the
global supply of donated blood," said Matt Sause, CEO of Roche
Diagnostics. “The approval of cobas Malaria represents a
significant advancement in malaria detection, offering healthcare
professionals a reliable tool for donor screening and improving the
safety of patients worldwide.”
Globally, a large number of possible donors are excluded from
giving blood because of travel to or from residences in
malaria-endemic areas. Existing microscopy and serological tests
are not sensitive enough to reliably mitigate malaria transfusion
risk.
The Roche Blood Safety Solutions offering provides the most
comprehensive molecular, serological testing and automation options
for donor screening in the US market.
In 2022, nearly half of the world's population was at risk of
malaria. While sub-Saharan Africa carries a disproportionately high
share of the global malaria burden, the WHO regions of Southeast
Asia, the Eastern Mediterranean, the Western Pacific, and the
Americas also report significant numbers of cases and deaths. There
were an estimated 249 million cases of malaria in 2022, and the
estimated number of malaria deaths stood at 608,000. In 2022, the
African Region was home to 94% and 95% of malaria cases and deaths,
respectively. 2
The test will be available in the United States at the end of Q2
2024. Approval in CE-marked countries is anticipated later this
year.
About the cobas Malaria test
The cobas Malaria test, a qualitative in vitro nucleic acid
screening test, allows for direct detection of Plasmodium RNA and
DNA in whole blood samples from individual human donors. The test,
which can be performed with other routine blood donor screening
tests, is designed for use on the cobas 6800/8800 Systems in the
U.S. The test is not intended for use to diagnose Plasmodium
infection, for use on cord blood samples or for use on cadaveric
blood specimens. The test utilises the Roche Whole Blood Collection
Tube, which allows for direct draw from the donor and is loaded
directly onto the cobas 6800/8800 Systems for increased workflow
efficiency.
About the cobas 6800 and cobas 8800 Systems
Since 2014, the cobas 6800 and cobas 8800 Systems have established
the new standard for routine molecular testing by delivering fully
integrated, automated solutions that serve the areas of donor
screening, infectious disease, sexual health, transplant,
respiratory and antimicrobial stewardship. The current molecular
donor screening assay menu includes cobas® MPX, cobas® DPX, cobas®
HEV, cobas® WNV, cobas® CHIKV/DENV, cobas® Zika and cobas® Babesia
(not all tests are available in the U.S.).
About Malaria
Malaria is a serious and sometimes fatal disease caused by a
parasite that commonly infects a certain type of mosquito which
feeds on humans. People who get malaria typically experience high
fever, shaking chills and flu-like symptoms. The disease can also
be transmitted through blood transfusion, organ transplant or the
shared use of needles or syringes contaminated with
blood.1
Malaria is preventable and curable. There are 5 parasite species
that cause malaria in humans, and 2 of these species – Plasmodium
falciparum and Plasmodium vivax – pose the greatest threat.
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1] CDC.gov “What is malaria? Frequently asked questions.
https://www.cdc.gov/malaria/about/index.html
[2] World Health Organisation. (n.d.). World Health Organisation.
Retrieved March 21, 2024, from
https://www.who.int/health-topics/malaria#tab=tab_1
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