CINCINNATI--(BUSINESS WIRE)--
Meridian Bioscience, Inc., Cincinnati, Ohio (NASDAQ: VIVO) today
announced the U.S. Food & Drug Administration (FDA) has re-categorized
Meridian’s illumigene® Group A Streptococcus
and illumigene® Group B Streptococcus
tests as “Moderate Complexity” under the Clinical Laboratory
Improvement Amendments (CLIA). Moderately complex tests are assays that
are considered to be simple and easy to use.
The Moderate Complexity categorization of both of these tests allows the
benefits of the illumigene platform to be available to all
Moderate Complexity laboratories that are in U.S. hospitals and clinics,
empowering them to offer an accurate, rapid, simple molecular test for
each of these pathogens.
illumigene Group A Streptococcus is a qualitative
molecular test for the detection of Group A Strep pharyngitis. Acute
pharyngitis is one of the most frequent illnesses for which
pediatricians and other primary care physicians are consulted, with an
estimated 15 million visits per year in the United States. Clinical
studies show that illumigene Group A Streptococcus increased
detection of positives by 53% over traditional culture in symptomatic
patients.
Group B Streptococcus (GBS) continues to be a major perinatal
pathogen, for both mothers and their infants, and is associated with
significant morbidity and mortality. illumigene Group B Streptococcus
fully complies with the CDC guidelines for the detection of GBS and
clinical studies have shown that broth enrichment, followed by testing
with illumigene Group B Streptococcus, increased
detection of true positives by 29% over traditional culture, thus
allowing for appropriate treatment of mother at time of delivery,
ensuring the best outcome for baby.
Jack Kraeutler, Chief Executive Officer, stated, “Due to its simplicity
and superior accuracy, our illumigene technology platform
enables most clinical labs to perform sophisticated molecular
diagnostics without the high costs of capital equipment and ongoing
service charges. The Moderate Complexity classification of the illumigene
Group A Streptococcus test and the illumigene Group
B Streptococcus test, along with illumigene C.
difficile, enables more labs to adopt molecular testing thereby
helping to provide better patient outcomes.”
Meridian is a fully integrated life science company that develops,
manufactures, markets and distributes a broad range of innovative
diagnostic test kits, purified reagents and related products and offers
biopharmaceutical enabling technologies. Utilizing a variety of methods,
these products and diagnostic tests provide accuracy, simplicity and
speed in the early diagnosis and treatment of common medical conditions,
such as gastrointestinal, viral and respiratory infections. Meridian’s
diagnostic products are used outside of the human body and require
little or no special equipment. The Company's products are designed to
enhance patient well-being while reducing the total outcome costs of
healthcare. Meridian has strong market positions in the areas of
gastrointestinal and upper respiratory infections, serology,
parasitology and fungal disease diagnosis. In addition, Meridian is a
supplier of rare reagents, specialty biologicals and related
technologies used by biopharmaceutical companies engaged in research for
new drugs and vaccines. The Company markets its products and
technologies to hospitals, reference laboratories, research centers,
diagnostics manufacturers and biotech companies in more than 60
countries around the world. The Company’s shares are traded on NASDAQ’s
Global Select Market, symbol VIVO. Meridian's website address is www.meridianbioscience.com.
Meridian Bioscience, Inc.
John A. Kraeutler, Chief Executive
Officer, 513-271-3700
Source: Meridian Bioscience, Inc.
