Transplant Genomics, Inc. Confirms TruGraf Will Receive Medicare Coverage Effective November 25, 2019
October 11 2019 - 1:29AM
Business Wire
Regulatory News:
Eurofins (Paris:ERF)
Transplant Genomics, Inc. (“TGI”), a molecular diagnostics
company committed to improving organ transplant outcomes with
non-invasive serial monitoring guided by genomics, today announced
that the Company’s TruGraf ® Blood Gene Expression Test qualifies
for Medicare coverage effective November 25, 2019. The Centers for
Medicare and Medicaid Services (CMS) released the final version of
the coverage policy issued by Palmetto GBA, the Medicare
administrator responsible for the MolDX technology assessment
program that evaluated TruGraf.
"This is a major milestone for TGI. TruGraf is the first blood
test that allows physicians to reassure patients with stable renal
function following kidney transplants that their graft is not
harboring silent rejection without the need for an invasive and
costly surveillance biopsy. Approximately 25% of stable kidney
transplant recipients harbor silent rejection, which previously
could only be ruled out by performing surveillance biopsies on
patients who appear to be perfectly fine" said Dr. Stan Rose,
President, Transplant Genomics. "Working together with our sister
Eurofins company Viracor, we have already begun discussions with
transplant nephrologists around the country who are looking forward
to incorporating TruGraf testing into their practice. “It’s been
estimated that greater than 60% of US kidney transplant patients
are covered by Medicare, meaning that most American kidney
transplant recipients with stable renal function will be eligible
to benefit from TruGraf testing,” added Rose.
Eurofins U.S. Clinical Diagnostics organization now offers an
expansive suite of testing services covering pre-transplant through
post-transplant patient monitoring. We provide the country’s most
comprehensive portfolio of transplant diagnostic tests, benefiting
the lives of kidney donors, those with end stage renal disease
awaiting transplant, and kidney transplant recipients.
About Transplant Genomics, Inc.
Transplant Genomics, Inc. (“TGI”) is a molecular diagnostics
company committed to improving organ transplant outcomes, with an
initial focus on kidney transplant recipients. Working with the
transplant community, TGI is commercializing a suite of tests
enabling diagnosis and prediction of transplant recipient immune
status. Test results will support clinicians with information to
optimize immune-suppressive therapy, enhance patient care and
improve graft survival. Test services are offered through TGI’s
CLIA laboratory in Pleasanton, CA. TGI was acquired by Eurofins in
2019.
Eurofins – a global leader in bio-analysis
Eurofins Scientific through its subsidiaries (hereinafter
sometimes “Eurofins” or “the Group”) believes it is a scientific
leader in food, environment, pharmaceutical and cosmetics products
testing and in agroscience CRO services. It is also one of the
global independent market leaders in certain testing and laboratory
services for genomics, discovery pharmacology, forensics, CDMO,
advanced material sciences and for supporting clinical studies. In
addition, Eurofins is one of the leading global emerging players in
specialty clinical diagnostic testing. With about 45,000 staff in
more than 800 laboratories across 47 countries, Eurofins offers a
portfolio of over 200,000 analytical methods for evaluating the
safety, identity, composition, authenticity, origin and purity of
biological substances and products, as well as for innovative
clinical diagnostic. The Group objective is to provide its
customers with high-quality services, accurate results on time and
expert advice by its highly qualified staff.
Eurofins is committed to pursuing its dynamic growth strategy by
expanding both its technology portfolio and its geographic reach.
Through R&D and acquisitions, the Group draws on the latest
developments in the field of biotechnology and analytical chemistry
to offer its clients unique analytical solutions and the most
comprehensive range of testing methods.
As one of the most innovative and quality oriented international
players in its industry, Eurofins is ideally positioned to support
its clients’ increasingly stringent quality and safety standards
and the expanding demands of regulatory authorities around the
world.
The shares of Eurofins Scientific are listed on the Euronext
Paris Stock Exchange (ISIN FR0000038259, Reuters EUFI.PA, Bloomberg
ERF FP).
Important disclaimer:
This press release contains forward-looking statements and
estimates that involve risks and uncertainties. The forward-looking
statements and estimates contained herein represent the judgment of
Eurofins Scientific’s management as of the date of this release.
These forward-looking statements are not guarantees for future
performance, and the forward-looking events discussed in this
release may not occur. Eurofins Scientific disclaims any intent or
obligation to update any of these forward-looking statements and
estimates. All statements and estimates are made based on the
information available to the Company’s management as of the date of
publication, but no guarantee can be made as to their validity.
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version on businesswire.com: https://www.businesswire.com/news/home/20191010005920/en/
MEDIA: Darren Lee, Vice President Transplant
Marketing Eurofins U.S. Clinical Diagnostics
508-337-6200 or DarrenLee@EurofinsUS.com
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