Test Available Exclusively through Labcorp in the
U.S. and Canada
Lille, France;
Cambridge,
MA; May
3, 2021 - GENFIT
(Nasdaq and Euronext: GNFT), a late-stage
biopharmaceutical company dedicated to improving the lives of
patients with metabolic and liver diseases, today
announced the launch of NASHnext®, a novel, noninvasive diagnostic
test for nonalcoholic steatohepatitis (NASH). The test is offered
exclusively in the U.S. and Canada through Labcorp, a leading
global life sciences company. NASHnext® is powered by NIS4™,
GENFIT’s proprietary diagnostic technology that uses a novel,
blood-based molecular biomarker test to identify NASH and
significant fibrosis, also referred to as at-risk NASH, in patients
with at least one metabolic risk factor, as published in The Lancet
Gastroenterology and Hepatology. 1
NASH, the most severe form of nonalcoholic fatty
liver disease (NAFLD), is a highly underdiagnosed cause of severe
liver complications. NAFLD, a precursor to NASH, is estimated to
affect nearly 80 million people in the U.S., but only 5 percent of
patients are aware of their liver disease due to its asymptomatic
nature and limited availability of tests, with highly invasive
liver biopsy being the current clinical standard to diagnose it.
Individuals meeting appropriate clinical criteria to support
suspected cases of NAFLD or NASH are target populations for
NASHnext® testing, one of the first blood-based tests that provides
a simple score for the diagnosis of both NASH and significant to
advanced liver fibrosis.
“Labcorp supported the research and development
of NASHnext® through our Drug Development business, and now through
our diagnostics capabilities, we can bring this valuable experience
and the test to millions of patients. NASH is a widespread yet
underdiagnosed liver disease with very serious consequences
including end-stage liver disease and cardiovascular events,” said
Brian Caveney, M.D.,
chief medical officer and president of
Labcorp Diagnostics. “NASHnext®
has the potential to substantially benefit very large patient
populations by providing people with essential information
regarding their liver health. With a clear diagnosis and the help
of their doctors, patients will be able to make informed decisions
and implement strategies to monitor or slow the progression of
their liver disease.”
In September 2020, GENFIT entered into a
licensing agreement with Labcorp for the development and
commercialization of a blood-based molecular diagnostic test
powered by GENFIT’s NIS4™ technology. Since early 2019, Labcorp
Drug Development has been offering the test to global researchers,
which has also provided Labcorp with valuable experience in the
validation and performance of the test. With the clinical launch of
NASHnext®, healthcare providers and patients across the U.S. and
Canada now have convenient access to this powerful new tool that
provides vital information about a serious health condition that is
underdiagnosed.
“The commercialization of NASHnext® by Labcorp
is a major milestone for the entire NASH field. We believe that the
capabilities and reach of Labcorp, a highly regarded life sciences
company, will allow for wide and early availability of the test to
help both patients and healthcare professionals manage NASH at
scale,” said Suneil
Hosmane, Global Head of Diagnostics at
GENFIT.
GENFIT is a pioneer in NASH diagnostics and is
committed to the development of additional diagnostics and
therapeutics in chronic liver disease.
Labcorp has been a leader in the development of
drugs and diagnostics for more than 50 years and is a recognized
global leader in NASH clinical trials. For more information about
NASH, visit: http://www.labcorp.com/NASH.
Financial terms for this agreement have not been
disclosed.
ABOUT GENFIT
GENFIT is a late-stage biopharmaceutical company
dedicated to improving the lives of patients with cholestatic and
metabolic chronic liver diseases. GENFIT is a pioneer in the field
of nuclear receptor-based drug discovery, with a rich history and
strong scientific heritage spanning more than two decades. GENFIT
is currently enrolling in ELATIVE™, a Phase 3 clinical trial
evaluating elafibranor in patients with Primary Biliary Cholangitis
(PBC). Elafibranor is an investigational compound that has not been
reviewed and has not received approval by any regulatory authority.
As part of GENFIT’s comprehensive approach to clinical management
of patients with liver disease, the Company is also developing
NIS4™, a new, non-invasive blood-based diagnostic technology which
could enable easier identification of patients with at-risk NASH.
NIS4™ technology has been licensed to LabCorp® in the U.S. and
Canada for the development and commercialization of a blood-based
molecular diagnostic test powered by NIS4™ technology. GENFIT has
facilities in Lille and Paris, France, and Cambridge, MA, USA.
GENFIT is a publicly traded company listed on the Nasdaq Global
Select Market and on compartment B of Euronext’s regulated market
in Paris (Nasdaq and Euronext: GNFT). www.genfit.com
ABOUT LABCORP
Labcorp is a leading global life sciences
company that provides vital information to help doctors, hospitals,
pharmaceutical companies, researchers, and patients make clear and
confident decisions. Through our unparalleled diagnostics and drug
development capabilities, we provide insights and accelerate
innovations to improve health and improve lives. With more than
70,000 employees, we serve clients in more than 100 countries.
Labcorp (NYSE: LH) reported revenue of $14.0 billion in FY2020.
Learn more about us at http://www.Labcorp.com or follow us on
LinkedIn and Twitter @Labcorp.
FORWARD LOOKING STATEMENTS
This press release contains certain
forward-looking statements with respect to GENFIT, including those
within the meaning of the Private Securities Litigation Reform Act
of 1995, with respect to GENFIT, including statements regarding the
potential market size and patient population for NASHNext®, the
diagnostic test powered by GENFIT’s NIS4® diagnostic technology and
developed by its partner Labcorp, the test’s and technology’s
ability to identify NASH with significant fibrosis and its
potential to contribute to NASH management and monitoring at a
large scale, and Labcorp’s capacity to disseminate it on a large
scale. The use of certain words, including “consider”,
“contemplate”, “think”, “aim”, “expect”, “understand”, “should”,
“aspire”, “estimate”, “believe”, “wish”, “may”, “could”, “allow”,
“seek”, “encourage” or “have confidence” or (as the case may be)
the negative forms of such terms or any other variant of such terms
or other terms similar to them in meaning is intended to identify
forward-looking statements. Although the Company believes its
projections are based on reasonable expectations and assumptions of
the Company’s management, these forward-looking statements are
subject to numerous known and unknown risks and uncertainties,
which could cause actual results to differ materially from those
expressed in, or implied or projected by, the forward-looking
statements. These risks and uncertainties include, among other
things, the uncertainties inherent in research and development,
including in relation to safety, biomarkers, progression of, and
results from, its ongoing and planned clinical trials, review and
approvals by regulatory authorities of its drug and diagnostic
candidates, exchange rate fluctuations and the Company’s continued
ability to raise capital to fund its development, as well as those
risks and uncertainties discussed or identified in the Company’s
public filings with the AMF, including those listed in Chapter 2
“Main Risks and Uncertainties” of the Company’s 2020 Universal
Registration Document filed with the AMF on 23 April 2021 under n°
D.21-0350, which is available on the Company’s website
(www.genfit.com) and on the website of the AMF (www.amf-france.org)
and public filings and reports filed with the U.S. Securities and
Exchange Commission (“SEC”) including the Company’s 2020 Annual
Report on Form 20-F filed with the SEC on April 23, 2021. In
addition, even if the Company’s results, performance, financial
condition and liquidity, and the development of the industry in
which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments
in future periods. These forward-looking statements speak only as
of the date of publication of this document. Other than as required
by applicable law, the Company does not undertake any obligation to
update or revise any forward-looking information or statements,
whether as a result of new information, future events or
otherwise.
LABCORP CAUTIONARY STATEMENT REGARDING
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking
statements, including but not limited to statements with respect to
Labcorp’s (the Company’s) future operations, expansion of offerings
and capabilities, and opportunities for future growth. Each of the
forward-looking statements is subject to change based on various
important factors, many of which are beyond the Company’s control,
including without limitation, the impact of the COVID-19 pandemic
on our business and financial condition, as well as on general
economic, business, and market conditions, competitive actions and
other unforeseen changes and general uncertainties in the
marketplace, changes in government regulations, including
healthcare reform, customer purchasing decisions, including changes
in payer regulations or policies, other adverse actions of
governmental and third-party payers, changes in testing guidelines
or recommendations, the effect of public opinion on the Company’s
reputation, adverse results in material litigation matters, failure
to maintain or develop customer relationships, our ability to
develop or acquire new products and adapt to technological changes,
failure in information technology, systems or data security, and
employee relations. These factors, in some cases, have affected and
in the future (together with other factors) could affect the
Company’s ability to implement the Company’s business strategy, and
actual results could differ materially from those suggested by
these forward-looking statements. As a result, readers are
cautioned not to place undue reliance on any of our forward-looking
statements. The Company has no obligation to provide any updates to
these forward-looking statements even if its expectations change.
All forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Further information on
potential factors, risks, and uncertainties that could affect
operating and financial results is included in the Company’s most
recent Annual Report on Form 10-K and subsequent Forms 10-Q,
including in each case under the heading RISK FACTORS, and in the
Company’s other filings with the SEC.
CONTACT
GENFIT | Investors
Tel: +1 (617) 714 5252 |
investors@genfit.com
PRESS RELATIONS | Media
Hélène LAVIN – Press relations | Tel: +333 2016
4000 | helene.lavin@genfit.com
CONTACT LABCORP:
Media: Christopher Allman-Bradshaw –
336-436-8263
Media@Labcorp.com
Investors: Chas Cook – 336-436-5076
Investor@Labcorp.com
1 Harrison SA, Ratziu V et al. A blood-based biomarker panel
(NIS4) for non-invasive diagnosis of non-alcoholic steatohepatitis
and liver fibrosis: a prospective derivation and global validation
study. Lancet Gastroenterol Hepatol, (in press). Accessed August 3,
2020.
https://www.thelancet.com/journals/langas/article/PIIS2468-1253(20)30252-1/fulltext
GENFIT | 885 Avenue Eugène Avinée,
59120 Loos - FRANCE | +333 2016 4000 |
www.genfit.com
- GENFIT announces the launch by Labcorp of NASHnext® A Novel
Noninvasive Diagnostic Test Powered by GENFIT’s NIS4™ Technology to
Identify Patients with At-Risk NASH
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