Trinity Biotech plc. (Nasdaq:TRIB), a leading developer and
manufacturer of diagnostic products for the point-of-care and
clinical laboratory markets, today announced that a CLIA waiver has
been received for Syphilis Health Check – a point-of-care rapid
test for the detection of Syphilis.
CLIA waiver has been granted by the U.S. Food and Drug
Administration (FDA) to Syphilis Health Check, which is the first
ever waiver for a rapid screening test for syphilis available in
the United States. The CLIA waiver has been granted to Diagnostics
Direct, LLC who are retaining distribution rights for the product
to the Physician's Office market, whilst Trinity Biotech will be
the exclusive distributor for the U.S. Public Health and Hospital
markets. Importantly, the waiver allows the test to be performed by
untrained healthcare workers in a variety of non-traditional
laboratory sites such as emergency rooms, health department
clinics, community-based organisations, physicians' offices and
other free standing counselling and testing locations. A copy of
the press release issued by the FDA is included below.
Syphilis Health Check is a qualitative rapid membrane
immune-chromatographic assay for the detection of Treponema
pallidum (Syphilis) antibodies in human whole blood, serum and
plasma. The test, which acts as a screening test, will primarily be
performed in a CLIA waived setting using finger stick samples of
whole blood only, with results being available in as little as 12
minutes. All positive tests should be followed up with further
syphilis serological laboratory testing and clinical evaluation
before final diagnosis.
Syphilis has been identified as a growing disease in the USA.
According to the Centers for Disease Control and Prevention (CDC)
there are approximately 55,000 new cases of primary and secondary
syphilis in the USA each year. This growth is particularly
prevalent amongst men who have sex with men (MSM), who now account
for more than 75% of all new cases, with an increasing number
occurring in the 15 to 24 age bracket. Early detection and
treatment is central to limiting the spread of the disease and
should help to reduce the risk of additional health issues in those
who contract it.
William Smith, Executive Director of the National Coalition of
STD Directors (NCSD) which represents state and local STD public
health programs across the country commented, "NCSD has been
working and advocating for years to bring this product to the wider
marketplace that a CLIA waiver makes possible. We have done so
because we have a public health emergency on our hands when it
comes to increases in syphilis rates and now we have a
point-of-care screening device that allows for timely and accurate
test results to intervene sooner in people who are infected.
It's a game changer and we are excited to get this test out into
our member health department programs."
Commenting on today's news, Ronan O'Caoimh, CEO of Trinity
Biotech, said, "We are delighted that Syphilis Health Check has
been CLIA waived. This is the only CLIA waived syphilis test now
available in the USA and will become a major platform in combating
the spread of syphilis, which has been increasing at an alarming
rate over recent years. Early detection has been identified as a
key step in this battle and this waiver now provides broader
availability and easier access which should contribute to a higher
rate of detection. Prior to the granting of this waiver there was
no product for rapid syphilis screening testing in the USA. In
addition, this test should act as an excellent companion product
for our Uni-Gold rapid HIV test which itself is CLIA waived and
services a similar patient demographic."
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forward-looking statements involve risks and uncertainties
including, but not limited to, the results of research and
development efforts, the effect of regulation by the United States
Food and Drug Administration and other agencies, the impact of
competitive products, product development commercialisation and
technological difficulties, and other risks detailed in the
Company's periodic reports filed with the Securities and Exchange
Commission.
Trinity Biotech develops, acquires, manufactures and markets
diagnostic systems, including both reagents and instrumentation,
for the point-of-care and clinical laboratory segments of the
diagnostic market. The products are used to detect infectious
diseases and to quantify the level of Haemoglobin A1c and other
chemistry parameters in serum, plasma and whole blood. Trinity
Biotech sells direct in the United States, Germany, France and the
U.K. and through a network of international distributors and
strategic partners in over 75 countries worldwide. For further
information please see the Company's website:
www.trinitybiotech.com
Press Release issued by the
FDA
The following press release was issued by the FDA on
December 15, 2014
The U.S. Food and Drug Administration today announced that it
granted the first-ever waiver, under certain laboratory
regulations, for a rapid screening test for syphilis, which will
allow the Syphilis Health Check test to be used in a greater
variety of health care settings.
According to the U.S. Centers for Disease Control and Prevention
(CDC), about 55,000 people in the United States are newly infected
with syphilis annually. During the 1990s, syphilis primarily
occurred among heterosexual men and women of racial and ethnic
minority groups; during the 2000s, however, cases increased among
men who have sex with men (MSM). Men who have sex with men
accounted for 75 percent of all primary and secondary syphilis
cases in 2012.
This sexually transmitted infection, caused by the bacterium
Treponema pallidum, can cause long- term complications or increase
the likelihood of HIV transmission if not adequately treated. The
syphilis bacterium can also infect the fetus of a woman during her
pregnancy, causing infant death, developmental delays and seizures.
CDC recommends that all pregnant women be tested for syphilis at
the first prenatal visit. Those who are at high risk, live in areas
with high rates of syphilis or were previously not tested should be
tested in the third trimester and again at delivery. CDC also
recommends screening at least once a year for syphilis for all
sexually active homosexual, bisexual, and other men who have sex
with men.
The FDA's waiver is related to the Clinical Laboratory
Improvement Amendments (CLIA), federal standards that apply to
clinical laboratory testing on humans, with certain exceptions.
Because the FDA granted a waiver under CLIA, the Syphilis Health
Check test can be distributed to a variety of nontraditional
laboratory sites, including physicians' offices, emergency rooms,
maternity wards, other health care facilities, health department
clinics, outreach sites, community-based organizations and other
freestanding counseling and testing sites. The waiver also allows
untrained health care workers to perform the tests on patients.
"The broader availability and easier access to this test should
contribute to a higher rate of detection of syphilis infection,"
said Alberto Gutierrez, Ph.D., director of the Office of In
VitroDiagnostics and Radiological Health in FDA's Center for
Devices and Radiological Health. The test is performed by obtaining
a sample of whole blood from a finger stick. Results are available
in as little as 12 minutes and may be performed in the presence of
the patient. All positive tests should be followed up with further
syphilis serological laboratory testing and clinical evaluation
before final diagnosis. The rapid result means that if a patient
tests positive, a health care worker can obtain a second blood
sample at the same office visit to confirm the test results through
further lab testing. This increases the probability that patients,
who might not return for a follow-up visit, will receive timely
treatment.
The FDA first cleared the Syphilis Health Check test in 2011 and
categorized it under CLIA as moderate- and high-complexity. The
type of CLIA certificate a laboratory obtains depends upon the
complexity of the tests it performs. CLIA regulations describe
three levels of test complexity: waived tests, moderate complexity
tests, and high complexity tests. The test was intended for use by
prescription only to detect Treponema palladium antibodies in
serum, plasma, and human whole blood.
The FDA granted a waiver under CLIA for the Syphilis Health
Check test after the manufacturer submitted data demonstrating the
test's ease of use and accuracy. The agency reviewed data for
finger sticks of whole blood samples from 417 subjects collected
over the course of four months at three testing sites representing
typical CLIA-waived sites, such as doctor's offices. Twelve
individuals not trained in the use of the Syphilis Health Check
test performed the tests on the study subjects. Results showed that
the Syphilis Health Check test, when used by untrained operators,
performed with high accuracy. This is critical if the test is to be
allowed for use outside of moderate- and high-complexity
laboratories.
With the issuance of the waiver, the Syphilis Health Check test
can be used by more laboratories as an initial screening test or in
conjunction with other appropriate laboratory tests and clinical
findings to aid in the diagnosis of syphilis infection. However,
the test is not intended for use in screening blood or plasma
donors.
The Syphilis Health Check test is manufactured by VEDA LAB of
Alencon, France for Diagnostics Direct, LLC, based in Cape May
Court House, New Jersey. It is also distributed by Trinity Biotech
USA, Inc., of Jamestown, New York.
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
CONTACT: Trinity Biotech plc
Kevin Tansley
(353)-1-2769800
E-mail: kevin.tansley@trinitybiotech.com
Lytham Partners LLC
Joe Diaz, Joe Dorame & Robert Blum
602-889-9700
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