GAITHERSBURG, Md., Aug. 6, 2020 /PRNewswire/ -- GeneDx, Inc., a
subsidiary of BioReference Laboratories, Inc., an OPKO Health
company (NASDAQ:OPK), today announced the launch of
GenomeXpress, a rapid genome sequencing test. Verbal
GenomeXpress results of pathogenic and/or likely
pathogenic variants in known disease causing genes are delivered to
the ordering healthcare provider within approximately seven days
after the start of testing. A written report for all confirmed
variants is sent to the provider within approximately 14 days after
start of testing. With the addition of GenomeXpress, GeneDx
expands its industry-leading clinical genomics portfolio to now
include three rapid sequencing options.
Genome sequencing is a test used to identify variations in any
part of the genome and is an important tool for diagnosing genetic
diseases. By including both protein-coding and non-coding regions
of the human genome including promoter, intronic, and untranslated
regions, GenomeXpress allows for the detection of
characterized/pathogenic variants in regions that are not assessed
by exome sequencing. Genetic changes can cause over 13,000
different diseases and patients often present with overlapping
symptoms.1 Finding the correct diagnosis is not always
straight-forward and may require multiple tests, costly
evaluations, invasive procedures and long hospital stays. A rapid
diagnosis can alter management, shorten the length of hospital
stays, reduce healthcare costs and save lives.
"With the new offering of GenomeXpress, we are advancing
healthcare," said Jane Juusola,
Ph.D., FACMG, Director of Clinical Genomics for GeneDx. "Rapid
genome sequencing paired with GeneDx's massive and ever-expanding
genomic database provides clinicians, patients and their families
with more meaningful information. As our database grows, we are
better able to distinguish likely pathogenic variants from likely
benign variants and subsequently identify new disease-causing
genes. Every patient who receives a GenomeXpress test
will benefit from both our current and future knowledge of genetic
disease."
"New and emerging scientific understanding is an imperative
aspect of genomics," said Adam
Logal, President of GeneDx and Chief Financial Officer of
OPKO Health. "Leveraging GeneDx's diverse database with a rapid
genome sequencing test may provide patients and their families with
options they did not have before. GenomeXpress utilizes
GeneDx's clinical genomics expertise, laboratory excellence and the
limitless value of the genome, as a future-facing sequencing
technology."
Genome sequencing has a diagnostic utility of
42-73%1-6 with a higher yield for cases that
specifically include other family members.2,5,7-11 With
a clinical utility of greater than four times that of chromosomal
microarray, genome sequencing should be considered a first-line
genomics test for children with suspected genetic
diseases.2
About GeneDx, Inc.
GeneDx, Inc. is a global leader in
genomics, providing testing to patients and their families from
more than 55 countries. Led by its world-renowned clinical genomics
program, GeneDx has an acknowledged expertise in rare and
ultra-rare genetic disorders, as well as one of the broadest menus
of sequencing services available among commercial laboratories.
GeneDx offers a suite of additional genetic testing services,
including diagnostic testing for hereditary cancers, cardiac,
mitochondrial, neurological disorders, prenatal diagnostics and
targeted variant testing. GeneDx is a subsidiary of BioReference
Laboratories, Inc., a wholly owned subsidiary of OPKO Health, Inc.
To learn more, please visit www.genedx.com.
About OPKO Health
OPKO is a multinational biopharmaceutical and diagnostics company
that seeks to establish industry-leading positions in large,
rapidly growing markets by leveraging its discovery, development,
and commercialization expertise and novel and proprietary
technologies. For more information, visit www.opko.com.
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 regarding
BioReference's testing for COVID-19 and the timing of and
availability of the test, the expected daily capacity for testing,
the ability to expand our test capacity, our ability to increase
COVID 19 testing availability nationwide, as well as the timeline
for doing so, and the expected turnaround time for testing of
hospital and non-hospital patients, 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 the OPKO Health, Inc. Annual Reports on
Form 10-K filed and to be filed with the Securities and Exchange
Commission and in its other filings with the Securities and
Exchange Commission. In addition, forward-looking statements may
also be adversely affected by equipment and reagent shortages,
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.
References:
- Clark et al., 2019
- Clark et al., 2018
- Soden et al. 2014
- Rady Children's Hospital-San Diego (2020). Project Baby Bear
Final Report
- Petrikin et al., 2018
- Gilissen et al. 2014
- Bick et al., 2017
- Willig et al., 2015
- Farnaes et al., 2018
- Kingsmore et al., 2019
- Scocchia et al., 2019
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SOURCE GeneDx, Inc.