March 18, 2015 9:04am EDT
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CAP Accreditation is Awarded to Clinical Laboratories Meeting the
Highest Standards of Excellence in Quality Laboratory Practices
NASHVILLE, Tenn. & MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) today announced that the College of
American Pathologists (CAP) has awarded accreditation to the OPKO Lab in
Nashville, Tennessee based on results of a recent on-site inspection.
This accreditation is awarded to facilities that meet the highest
standards of quality in laboratory services. With this recognition, OPKO
Lab joins the prestigious ranks of some of the most prominent clinical
laboratories in the world.
"We are extremely proud to receive CAP accreditation," stated David
Okrongly, OPKO Lab’s President. “This important milestone reflects our
commitment to providing the highest quality standards for our clinicians
and their patients."
The U.S. federal government recognizes the CAP Laboratory Accreditation
Program, which began in the early 1960s, as being equal-to or
more-stringent-than the government's own inspection program. During the
CAP accreditation process, inspectors examine the laboratory's quality
system, quality control program and quality records for the preceding
two years. CAP inspectors also examine laboratory staff qualifications,
validation of tests and systems, equipment, facilities, safety program
and record, and overall management.
“The OPKO Lab team has always held the quality of the results we provide
to our physicians and patients as central to our mission,” said Dr.
Vinita Mathur, Laboratory Director of OPKO Lab. “The College of American
Pathology accreditation is recognition of our commitment to quality and
makes us all very proud.”
About OPKO Lab
OPKO Lab, a laboratory certified under the Clinical Laboratory
Improvement Amendments of 1988, as amended (“CLIA”), operates as a
full-service medical laboratory with a urologic focus and serves as the
commercial platform for the U.S. launch of the 4Kscore test®. OPKO Lab
is a division of OPKO Health, Inc., a multi-national pharmaceutical and
diagnostic company. OPKO Health, Inc. works to establish
industry-leading positions in medical markets through discovery,
development, and commercialization expertise and through novel
technologies. OPKO's offerings include point-of-care diagnostics, novel
molecular diagnostics, and proprietary pharmaceuticals and vaccines. For
more information, visit http://www.opko.com .
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies risk for
aggressive prostate cancer. The 4Kscore measures the blood plasma levels
of four different prostate-derived kallikrein proteins: Total PSA, Free
PSA, Intact PSA and Human Kallikrein-2 (hK2). These biomarkers are
combined with a patient's age, Digital Rectal Exam (DRE) status (nodule
/ no nodule), and prior negative biopsy status (yes / no) using a
proprietary algorithm to calculate the risk (probability) of finding a
Gleason Score 7 or higher prostate cancer. The four kallikrein panel of
biomarkers utilized in the 4Kscore Test is based on over a decade of
research conducted by scientists at Memorial Sloan-Kettering Cancer
Center and leading European institutions. The 4Kscore Test provides
individualized risk for the presence of aggressive prostate cancer and
adds new information to the shared decision making discussion between
Urologists and their patients.
About the College of American Pathologists
The College of American Pathologists (CAP), celebrating 50 years as the
gold standard in laboratory accreditation, is a medical society that
serves more than 18,000 physician members and the global laboratory
community. It is the world's largest association composed exclusively of
board-certified pathologists and is the worldwide leader in laboratory
quality assurance. The College advocates accountable, high-quality, and
cost-effective patient care. More information about the CAP can be found
at www.cap.org .
SAFE HARBOR STATEMENT
This press release contains "forward-looking statements," as that
term is defined under the Private Securities Litigation Reform Act of
1995 (PSLRA), which statements may be identified by words such as
"expects," "plans," "projects," "will," "may," "anticipates,"
"believes," "should," "intends," "estimates," and other words of similar
meaning, including statements regarding our ability to maintain CAP
accreditation, expected benefits of the 4Kscore test, that the 4Kscore
will accurately identify risk for aggressive prostate cancer, whether
the test will bring great benefit to patients and the healthcare system
by helping avoid the cost of unnecessary, sometimes harmful procedures,
whether the test will accurately predict high-grade cancers, whether
OPKO will successfully commercialize the 4Kscore, the market for and
expected sales of 4Kscore, whether the test will be an important benefit
for Urologists and their patients and will lead to lower overall
healthcare costs, as well as other non-historical statements about our
expectations, beliefs or intentions regarding our business, technologies
and products, financial condition, strategies or prospects. Many factors
could cause our actual activities or results to differ materially from
the activities and results anticipated in forward-looking statements.
These factors include those described in our filings with the Securities
and Exchange Commission, as well as the risks inherent in funding,
developing and obtaining regulatory approvals of new,
commercially-viable and competitive products and treatments. In
addition, forward-looking statements may also be adversely affected by
general market factors, competitive product development, product
availability, federal and state regulations and legislation, the
regulatory process for new products and indications, manufacturing
issues that may arise, patent positions and litigation, among other
factors. The forward-looking statements contained in this press release
speak only as of the date the statements were made, and we do not
undertake any obligation to update forward-looking statements. We intend
that all forward-looking statements be subject to the safe-harbor
provisions of the PSLRA.
OPKO Health, Inc.
David Okrongly, 305-575-4100
Source: OPKO Health, Inc.
Released March 18, 2015
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