New Testing Procedure Holds Promise As a Critical Tool in the Global Effort to Eliminate Malaria

New Testing Procedure Holds Promise As a Critical Tool in the Global Effort to Eliminate Malaria

ID: 537751

(Thomson Reuters ONE) -


Field laboratory-deployable molecular test up to 80,000 times more sensitive
than current options

CINCINNATI, April 24, 2017 (GLOBE NEWSWIRE) -- As the global community gathers
for World Malaria Day to celebrate successes and plot strategy to eliminate the
disease from the face of the earth, a new ray of hope is emerging from a
surprising place: the testing side of the equation.

Meridian Bioscience, Inc. of Cincinnati, Ohio (NASDAQ:VIVO) has
developed illumigene® Malaria, a molecular-based, field laboratory-deployed test
for malaria that is up to 80,000 times more sensitive at detecting the malaria
parasite than current testing options. The test was developed by Meridian with
the technical assistance of the Centers for Disease Control and Prevention (CDC)
and Cheikh Anta Diop University of Dakar, Senegal.

"illumigene Malaria has the potential to change current practices. Faster and
more accurate diagnosis is vital in the fight against malaria," said Professor
Daouda Ndiaye, Department of Parasitology-Mycology, Cheikh Anta Diop University.
"Earlier diagnosis enables the correct treatment to be prescribed, which leads
to better clinical outcomes for the person with malaria and keeps malaria
treatments for the right people. And because detecting the malaria parasite in
people with a low parasite count has proven difficult, a robust, sensitive and
field laboratory-deployable diagnostic tool is needed to track the malaria
reservoir in pre-elimination regions. illumigene Malaria shows this capacity."

illumigene Malaria was awarded first place for innovation in emergency treatment
and point-of-care testing at the prestigious Journées Internationales de
Biologie /Association des Colloques Nationaux des Biologistes Conference in
Paris, and is CE marked for sale in Europe.

Despite a 60% decline in malaria deaths since 2000 due to better prevention and




increased control measures, malaria is still one of the top three killers of
children worldwide, claiming one life every minute of every day. (1) According
to the latest data from the World Health Organization, nearly half of the
world's population is at risk of malaria (2). In 2015, there were roughly 212
million malaria cases and an estimated 429,000 malaria deaths (3). Also that
year, Sub-Saharan Africa was home to 90% of malaria cases and 92% of malaria
deaths (4). More than two-thirds (70%) of all malaria deaths occur in children
under the age of five (5).

While malaria is preventable and treatable (6), proper diagnosis is critical.
Molecular testing has proven to be more effective than current options in
detecting the malaria parasite at very low levels, known as "loads." Identifying
low-load individuals has the dual benefit of ensuring they receive treatment and
preventing the spread of the disease to others.

"People can be carriers of malaria without showing any symptoms, and detecting
these asymptomatic individuals can be challenging," said Slava Elagin, Executive
Vice President, Research & Development at Meridian Bioscience. "If testing
doesn't identify them, eliminating malaria is impossible because these
individuals can spread the disease to others."

That scenario is playing out in the fact that malaria is no longer only a
disease of sub-Saharan Africa and southern Asia. Increasing numbers of people
emigrating from countries where malaria is endemic have resulted in a higher
incidence in Europe and the Middle East. The proportion of imported malaria
cases has increased during the last few years from 14% to 86% in more recent
studies. On pooling the reports, nearly 43% of malaria cases registered in key
European centers occurred in non-nationals. The rates of malaria are much higher
in settled immigrants who travel to visit friends and relatives in their country
of origin. They can account for up to 70% of the cases in several reports and
this increase highlights the need for better diagnostic tools in both non-
endemic and endemic countries.

While not a new concept, molecular testing has traditionally been a complex
process requiring fully-equipped laboratories and highly trained testing
personnel. The breakthrough of illumigene Malaria by Meridian Bioscience is that
it can be deployed in the field laboratory, where malarial infection is the
highest and low load detection most challenging to diagnose and
treat. illumigene Malaria is user-friendly, doesn't require special training or
capital investment, yields results in under one hour and the testing materials
can be stored at room temperature.

"This is a major step forward in the fight to bring better care to those
infected with malaria and to stop its spread," said John A. Kraeutler, Chief
Executive Officer and Chairman of the Board of Meridian Bioscience.

The availability of the field laboratory-deployable and user-
friendly, illumigene Malaria, will enhance rather than replace existing testing
protocols. It will join rapid diagnostic tests (RDTs) and microscopy to create a
web of detection protocols that will help direct treatment where it is needed
most.

"Malaria is a devastating disease and we are proud to work with all the talented
and dedicated individuals around the world in the fight to eliminate it," said
Kraeutler.

illumigene Malaria will be distributed in the European, Middle Eastern and
African regions by Meridian Bioscience Europe and in additional international
markets by the Company's global distribution network. It is the tenth assay now
available on our illumigene platform that is in use in nearly 1,500 institutions
around the world.

1 - Meridian news release, "New Malaria Test, illumigene Malaria, Sets a New
Gold Standard for Diagnosis", 1.26.16
2 - World Health Organization: 10 facts on malaria
(http://www.who.int/features/factfiles/malaria/en/) Updated December 2016
3 - ibid
4 - ibid
5 - ibid
6 - The World Health Organization, Global Technical Strategy for Malaria:
2016-2030

About Meridian Bioscience, illumigene Malaria & LAMP Technology

* illumigene Malaria is a diagnostic test for malaria developed by Meridian
Bioscience. It is a molecular test that uses Loop-Mediated Isothermal
Amplification (LAMP) technology to amplify DNA and detect the presence of
the Malaria parasite.
* LAMP (Loop Mediated Isothermal Amplification) is Molecular detection
technology which targets DNA and uses premeasured and self-contained
reagents.  Unlike current PCR testing, it does not require temperature
cycling. LAMP incubates, detects and reports at a single temperature,
allowing for faster results. illumigene testing kits can be stored under
ambient conditions, while current molecular methods require cold storage.
* illumigene technology is simple, accurate and easy to use which means that
no specialist technical expertise is needed to perform the test. Results are
available in under an hour.
* LAMP-based illumigene tests are already used to diagnose infectious diseases
including C. difficile, whooping cough and Herpes Simplex Virus, where they
have proved highly accurate.
* illumigene tests have been approved and used in other diseases for over 5
years.
* The benefits of illumigene Malaria are highlighted on the
microsite: www.molecularendsmalaria.com.
About Meridian Bioscience, Inc
Meridian is a fully integrated life science company that develops, manufactures,
markets and distributes a broad range of innovative diagnostic test kits, rare
reagents, specialty biologicals and components. Utilizing a variety of methods,
our diagnostic tests provide accuracy, simplicity and speed in the early
diagnosis and treatment of common medical conditions, such as infections and
lead poisoning. Meridian's diagnostic products are used outside of the human
body and require little or no special equipment. The Company's diagnostic
products are designed to enhance patient well-being while reducing the total
outcome costs of health care. Meridian has strong market positions in the areas
of gastrointestinal and upper respiratory infections and blood lead level
testing. In addition, Meridian is a supplier of rare reagents, specialty
biologicals and components used by organizations in the life science and agribio
industries engaged in research and by companies as components in the manufacture
of diagnostics. The Company markets its products and technologies to hospitals,
reference laboratories, research centers, diagnostics manufacturers and agribio
companies in more than 70 countries around the world. The Company's shares are
traded on the NASDAQ Global Select Market, symbol VIVO. Meridian's website
address is www.meridianbioscience.com.

For Investor Relations, contact:
513-271-3700
John A. Kraeutler, Chief Executive Officer

For all other inquiries, contact:
513-403-7222
Joe Shields





This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.

Source: Meridian Bioscience, Inc. via GlobeNewswire




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Datum: 24.04.2017 - 09:30 Uhr
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