November 12, 2015 9:20am EST
Download as PDF
MIAMI--(BUSINESS WIRE)--
OPKO Health, Inc. (NYSE:OPK) announced today that the American Medical
Association (AMA) Current Procedural Terminology (CPT®) Editorial Panel
has granted a Category I CPT code for its 4Kscore® Test, the only blood
test that accurately identifies an individual patient’s risk for
aggressive prostate cancer. This important event upgrades the 4Kscore
Test from a Category III Administrative code to a Category I CPT code, a
designation reserved for established diagnostic tests, and will provide
broader access to the 4Kscore Test to urologists and their patients
across the United States.
“The CPT Category I approval is recognition by the leading panel of
medical experts in the United States that the 4Kscore Test is now an
established diagnostic test addressing an important unmet medical need,”
said David Okrongly, Ph.D., President of OPKO Diagnostics. “The multiple
peer-reviewed clinical studies, inclusion of the 4Kscore Test in the
2015 National Comprehensive Cancer Network (NCCN) guidelines for
Prostate Cancer Early Detection, and the growing adoption of the test in
the United States were key factors in the decision by the CPT Editorial
Board reviewers.”
“This is a major milestone for the 4Kscore Test toward providing access
to the 4Kscore Test for all eligible patients,” said Phillip Frost,
M.D., OPKO's Chairman and Chief Executive Officer. “We believe it will
help streamline claims processing and accelerate further coverage and
adoption decisions by payers, physicians, and patients.”
About the 4Kscore Test
The 4Kscore is the only blood test that accurately identifies an
individual patient’s risk for aggressive prostate cancer, the lethal
form of prostate cancer. The 4Kscore uses a proprietary algorithm that
incorporates the blood levels of four different prostate-derived
kallikrein proteins: Total PSA, Free PSA, Intact PSA and Human
Kallikrein-2 (hK2), plus the patient's age, and other clinical
information to calculate the percentage risk (probability) of finding a
Gleason Score 7 or higher grade of 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 and is included as a
standard of care in the 2015 NCCN Prostate Cancer Early Detection
Guidelines. The 4Kscore Test provides individualized risk for the
presence of aggressive prostate cancer and adds new information to the
shared decision making discussion between the Urologist and the patient.
About Category I CPT Codes
In addition to facilitating reimbursement in government programs such as
Medicare and Medicaid, CPT codes are used by other insurance companies
and government payers to describe health care services and procedures.
The AMA CPT Editorial Panel has established criteria for Category I
designation of new diagnostic tests and the details are available on the
AMA website. In summary, the Category I criteria include: performance of
the test in an appropriately regulated laboratory environment, ordering
of the test by many physicians and at a volume consistent with the
intended clinical use, demonstration that the use of the test is
consistent with current medical guidelines, and published scientific
evidence of clinical efficacy.
About OPKO Health
OPKO Health, Inc. is a diversified healthcare company that seeks to
establish industry-leading positions in large, rapidly growing markets.
Our diagnostics business includes Bio-Reference Laboratories, the
nation’s third-largest clinical laboratory with a core genetic testing
business and a 420-person salesforce to drive growth and leverage new
products, including the 4Kscore® prostate cancer test and the Claros®1
in-office immunoassay platform. Our pharmaceutical business features
Rayaldee™, a treatment for secondary hyperparathyroidism in stage 3-4
chronic kidney disease patients with vitamin D deficiency (March 29,
2016 PDUFA date) and VARUBI™ for chemotherapy-induced nausea and
vomiting (oral formulation approved by FDA and pending launch by partner
Tesaro, IV formulation in Phase 3). Our biologics business includes
hGH-CTP, a once-weekly human growth hormone injection (in Phase 3 and
partnered with Pfizer), and a long-acting Factor VIIa drug for
hemophilia (entering Phase 2a). We also have production and distribution
assets worldwide, multiple strategic investments and an active business
development strategy. More information is available at www.opko.com .
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 expected benefits of the
4Kscore, the power of the 4Kscore to provide valuable information to
accurately identify aggressive prostate cancer and guide clinical
decision making, whether it will accurately predict high-grade
cancers, improve patient outcomes and reduce health care costs, whether
OPKO will successfully commercialize the 4Kscore, and the market for and
expected sales of 4Kscore, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151112005826/en/
OPKO Health, Inc.
Tara Mackay, 305-575-4100
Investor Relations
or
Media
Rooney
& Associates
Terry Rooney, 212-223-0689
or
Marion
Janic, 212-223-4017
or
Investors
LHA
Anne
Marie Fields, 212-838-3777
or
Bruce
Voss, 310-691-7100
Source: OPKO Health
Released November 12, 2015
email Email Alerts
location_city Company Profile
contact_page Contacts
rss_feed RSS News Feed
account_tree Sitemap
Apply on OPKO Health (Ireland)’s careers page