- Reinforces Baxter and bioMérieux’s shared commitment to
enhancing acute kidney injury (AKI) management through informed
clinical decision-making and patient-centered approaches
- Aids hospitals in optimizing critical care resources by helping
anticipate appropriate level of care for AKI patients
- Research suggests CCL14 is the most predictive biomarker of
persistent severe AKI when compared with other AKI biomarkers
Baxter International Inc. (NYSE:BAX), a global leader in acute
care, and bioMérieux (EPA:BIM), a global leader in in vitro
diagnostics, today announced the CE marking of the
NEPHROCLEAR™ CCL14 Test. The NEPHROCLEAR™
CCL14 Test is designed to predict persistent severe acute
kidney injury (PS-AKI) and can be used to support timely clinical
decision-making and care pathways. The companies intend to
commercially launch the NEPHROCLEAR™ CCL14 Test in
western Europe in 2022.
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“Baxter is proud to partner with bioMérieux to offer the
NEPHROCLEAR™ CCL14 Test as an important new
diagnostic option to support individualized AKI management that
gives every patient the greatest opportunity for recovery,” said
Reaz Rasul, general manager of Baxter’s Acute Therapies business.
“We remain committed to advancing purposeful innovation across the
care continuum to help reduce complexity and enable efficiencies in
critical care, especially as hospitals continue to feel the impact
of the COVID-19 pandemic.”
“This new step in our collaboration with Baxter further
strengthens our innovative diagnostics solutions portfolio for the
management of AKI,” said Pierre Boulud, chief operating officer,
clinical operations, bioMérieux. “True to our public health
mission, we bring to the medical community this high-medical-value
immunoassay that has the potential to change the current strategy
of care for patients suffering from AKI.”
AKI is a sudden decrease in kidney function over a period of
hours to days, often as a result of illness, trauma or infection.
The sudden loss of kidney function leads to the accumulation of
toxins and fluid in the blood that, if left untreated, may lead to
death. Baxter recently collaborated with bioMérieux and Premier
Applied Sciences® (PAS) to conduct a study assessing the economic
and clinical impact of PS-AKI. Data from this study presented at
the International Symposium on Intensive Care and Emergency
Medicine (ISICEM) showed that PS-AKI (stage 3 AKI lasting ≥ 3 days)
is independently associated with a longer length of stay and higher
costs during index hospitalization and 30-day follow-up compared to
non-persistent AKI. Additional data from this study, presented at
the European Society of Intensive Care Medicine (ESICM) LIVES
congress, showed that PS-AKI is prevalent among hospitalized adults
in the U.S. and is associated with a significantly higher risk of
death during hospitalization, as well as readmissions, dialysis and
death during 30-day follow-up, compared to patients without
PS-AKI.
A consensus statement from the Acute Disease Quality Initiative
Consensus Conference underscores the importance of new biomarkers
like CCL14 (C–C motif chemokine ligand 14), the biomarker measured
by the NEPHROCLEAR™ CCL14 Test, in helping to manage
AKI by identifying high-risk patient groups, guiding therapy and
improving care pathways.1 Recent studies published in Intensive
Care Medicine,2 Critical Care3 and Journal of Thoracic and
Cardiovascular Surgery4 suggest that CCL14 is the most predictive
biomarker of PS-AKI when compared with other AKI biomarkers,
including NGAL, CHI3L1, L-FABP, Cystatin C, Proenkephalin, and
KIM-1.
The NEPHROCLEAR™ CCL14 Test provides a reliable
and precise measurement to help clinicians assess an individual
patient’s risk for developing PS-AKI. The test’s area under the
receiver operating characteristic curve (AUC), which is an
indicator of the overall accuracy of a diagnostic test, is 0.82,
illustrating the CCL14 biomarker’s ability to distinguish patients
who will likely develop PS-AKI from those who will not.2, 5 The
test results can help clinicians determine personalized treatment
approaches for each patient, including level of care and the need
for appropriate interventions, based on KDIGO (Kidney Disease
Improving Global Outcomes) clinical practice guidelines.3, 5, 6
When test results show a patient is at increased risk for PS-AKI,
they may be triaged to a higher level of care to help mitigate
potential complications of AKI.2, 3
Baxter and bioMérieux previously announced an agreement to
develop and distribute this novel AKI biomarker test to assess the
risk of PS-AKI and support clinical decision-making in AKI
management. Both companies will provide support at the customer
site for the NEPHROCLEAR™ CCL14 Test, while
bioMérieux retains control over the regulatory approval process and
Baxter retains control over the commercialization strategy. Baxter
is bioMérieux’s exclusive distributor of the NEPHROCLEAR™
CCL14 Test in Europe and will also be the exclusive
distributor in the U.S. pending clearance from the U.S. Food and
Drug Administration (FDA).
CE-Marked Intended Purpose/Important Safety Information for
the NEPHROCLEAR™ CCL14 Test
The NEPHROCLEAR™ CCL14 Test is an automated
immunofluorescence assay for use on the ASTUTE140® Meter for the
quantitative measurement of CCL14 (C-C motif chemokine ligand 14)
in human urine.
The NEPHROCLEAR™ CCL14 Test is intended to be used
in conjunction with clinical evaluation in adult patients who are
in the hospital for an acute illness or condition and have moderate
or severe (Stage 2 or 3) acute kidney injury (AKI) as an aid in the
risk assessment for developing persistent severe AKI (Stage 3 AKI
lasting ≥ 72 hours) within 48 hours of patient assessment.
Rx Only. For safe and proper use of the products mentioned
herein, please refer to the Operator’s Manual or Instruction for
Use.
About Baxter
Every day, millions of patients and caregivers rely on Baxter’s
leading portfolio of critical care, nutrition, renal, hospital and
surgical products. For 90 years, we’ve been operating at the
critical intersection where innovations that save and sustain lives
meet the healthcare providers that make it happen. With products,
technologies and therapies available in more than 100 countries,
Baxter’s employees worldwide are now building upon the company’s
rich heritage of medical breakthroughs to advance the next
generation of transformative healthcare innovations. To learn more,
visit www.baxter.com and follow us on Twitter, LinkedIn and
Facebook.
About bioMérieux
Pioneering Diagnostics
A world leader in the field of in vitro diagnostics for over 55
years, bioMérieux is present in 44 countries and serves more than
160 countries with the support of a large network of distributors.
In 2020, revenues reached €3.1 billion, with over 90% of
international sales (outside of France).
bioMérieux provides diagnostic solutions (systems, reagents,
software and services) which determine the source of disease and
contamination to improve patient health and ensure consumer safety.
Its products are mainly used for diagnosing infectious diseases.
They are also used for detecting microorganisms in agri-food,
pharmaceutical and cosmetic products.
bioMérieux is listed on the Euronext Paris stock market. Symbol:
BIM – ISIN Code: FR0013280286. Reuters: BIOX.PA/Bloomberg: BIM.FP.
Corporate website Investor website
This release includes forward-looking statements concerning the
NEPHROCLEAR™ CCL14 Test, including potential benefits
associated with the product. The statements are based on
assumptions about many important factors, including the following,
which could cause actual results to differ materially from those in
the forward-looking statements: demand for and market acceptance
for new and existing products; product development risks; inability
to create additional production capacity in a timely manner or the
occurrence of other manufacturing or supply difficulties (including
as a result of natural disasters, public health crises and
epidemics/pandemics, regulatory actions or otherwise); satisfaction
of regulatory and other requirements; actions of regulatory bodies
and other governmental authorities (including potential FDA
clearance of the NEPHROCLEAR™ CCL14 Test); product
quality, manufacturing or supply, or patient safety issues; changes
in law and regulations; and other risks identified in Baxter's most
recent filing on Form 10-K and other SEC filings, all of which are
available on Baxter's website. Baxter does not undertake to update
its forward-looking statements.
Baxter is a registered trademark of Baxter International Inc.
BIOMÉRIEUX, the BIOMÉRIEUX logo, ASTUTE140, and NEPHROCLEAR are
pending or registered trademarks belonging to bioMérieux or one of
its subsidiaries.
1 Ostermann M, Zarbock A, Goldstein S, et al. Recommendations on
Acute Kidney Injury Biomarkers From the Acute Disease Quality
Initiative Consensus Conference: A Consensus Statement. JAMA Netw
Open. 2020;3(10):e2019209.
doi:10.1001/jamanetworkopen.2020.19209
2 Hoste E, Bihorac A, Al-Khafaji, A, et al. Identification and
validation of biomarkers of persistent acute kidney injury: the
RUBY study. Intensive Care Med 46, 943–953 (2020).
https://doi.org/10.1007/s00134-019-05919-0
3 Bagshaw, S.M., Al-Khafaji, A., Artigas, A. et al. External
validation of urinary C–C motif chemokine ligand 14 (CCL14) for
prediction of persistent acute kidney injury. Crit Care 25, 185
(2021). https://doi.org/10.1186/s13054-021-03618-1
4 Massoth C, et al. Comparison of C-C motif chemokine ligand 14
with other biomarkers for adverse kidney events after cardiac
surgery. J Thorac Cardiovasc Surg. 2021 Mar
10:S0022-5223(21)00436-0. doi: 10.1016/j.jtcvs.2021.03.016
5 BioMerieux NephroClear CCL14 Test Kit Package Insert
6 International Society of Nephrology. (2012) KDIGO Clinical
Practice Guideline for Acute Kidney Injury. Kidney Int. Suppl.2,
1-138.
https://kdigo.org/wp-content/uploads/2016/10/KDIGO-2012-AKI-Guideline-English.pdf
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211021005916/en/
Media Contacts Baxter: Andrea Johnson, (224) 948-5353
media@baxter.com bioMérieux: Romain Duchez, +33 (0)4 78 87 21 99
media@biomerieux.com
Investor Contacts Baxter: Clare Trachtman, (224) 948-3020
bioMérieux: Franck Admant, +33 (0)4 78 87 20 00
investor.relations@biomerieux.com
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