Novitas Issues Proposed Local Coverage Determination for the 4Kscore® Test

Proposed LCD
will allow Medicare coverage within criteria for the 4Kscore® Test

MIAMI, June 28, 2019 (GLOBE NEWSWIRE) — OPKO Health, Inc. (OPK) today announced that Novitas Solutions, Inc. has issued a new proposed local coverage determination (LCD) for the 4Kscore® test, with defined coverage criteria.  Under the LCD, Medicare will reimburse the test for patients who meet the defined criteria.  The full text of the updated LCD can be found here.

The 4Kscore®
test is a blood test used by health care professionals to assess a man’s risk
of having aggressive prostate cancer after an abnormal prostate specific
antigen (PSA) test result.  OPKO has offered the 4Kscore® test since 2014
in the U.S., Europe, and elsewhere.

The 4Kscore®
test has been included in the National Comprehensive Cancer Network Guidelines®
(NCCN) since 2015, and European Association of Urology Prostate Cancer
Guidelines since 2016.

Novitas serves
as the Medicare Administrative Contractor for a jurisdiction that includes New
Jersey, where OPKO’s BioReference Laboratories, Inc. is located and where all
4Kscore® testing is performed.  On June 20, 2019, OPKO announced it
submitted a de novo request to the U.S. Food and Drug Administration seeking
regulatory clearance for the 4Kscore® test.

About OPKO Health, Inc.

OPKO Health is
a diversified healthcare company.  In diagnostics, its subsidiary
BioReference Laboratories, Inc. is the nation’s third-largest clinical
laboratory; GeneDx is a rapidly growing genetic testing business; the 4Kscore®
prostate cancer test is used to confirm an elevated PSA to help decide about next
steps such as prostate biopsy; Claros® 1 is a point-of-care diagnostics
platform with a total PSA test approved by the FDA and testosterone as the most
advanced test in development.  In our pharmaceutical pipeline, RAYALDEE is
our first pharmaceutical product to be marketed.  OPK88003, a once-weekly
oxyntomodulin for type 2 diabetes and obesity, recently reported positive data
from a Phase 2 clinical trial.  OPK88003 is among a new class of
GLP-1/glucagon receptor dual agonists.  OPK88004, a SARM (selective
androgen receptor modulator), is currently being studied for various potential
indications.  The company’s most advanced product utilizing its CTP
technology, a once-weekly human growth hormone for injection, is in Phase 3
trials and is partnered with Pfizer.  OPKO also has research, development,
production and distribution facilities abroad.  More information is
available at

Cautionary Statement Regarding Forward-Looking Statements

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 about expected benefits of the 4Kscore® test, the expected
final coverage determination for the test and conditions for coverage, whether
the test will be cleared or approved by the FDA, 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 Annual
Reports on Form 10-K filed and to be filed with the Securities and Exchange
Commission and in our other filings with the Securities and Exchange
Commission, as well as integration challenges for BioReference and other
acquired businesses, liquidity issues and the risks inherent in funding,
developing and obtaining regulatory approvals of new, commercially-viable and
competitive products and treatments, that earlier clinical results of
effectiveness and safety may not be reproducible or indicative of future
results, that the 4Kscore® and/or any of our compounds or diagnostic products
under development may fail, may not achieve the expected results or
effectiveness and may not generate data that would support the approval or
marketing of products for the indications being studied or for other
indications, that currently available over-the-counter and prescription
products, as well as products under development by others, may prove to be as
or more effective than our products for the indications being studied. 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.