- Reinforces Baxter’s commitment to purposeful innovation that
supports broader acute kidney injury (AKI) management to improve
patient outcomes
- Combines Baxter’s global leadership in blood purification and
focus on advancing patient-centered care with bioMérieux’s global
leadership in diagnostics
- Recent study highlights role of biomarker in predicting
persistent severe AKI
Baxter International Inc. (NYSE:BAX), a global leader in acute
care, today announced a distribution agreement with bioMérieux
(EPA:BIM), a global leader in in vitro diagnostics, for the
NEPHROCLEARTM CCL14 diagnostic test. The NEPHROCLEARTM CCL14 test
is currently in development for use in assessing the risk of
developing persistent severe acute kidney injury (AKI). The
agreement is part of a previously announced collaboration between
Baxter and bioMérieux to improve identification and treatment of
AKI. Financial terms of the agreement were not disclosed.
As part of the agreement, Baxter will be bioMérieux’s exclusive
distributor of the NEPHROCLEARTM CCL14 test in Europe and the U.S.
following regulatory approval and launch in both markets. Baxter
and bioMérieux will share in-country commercialization, while
bioMérieux will retain control over the regulatory approval
process. Incorporating new diagnostic products into Baxter’s Acute
Therapies portfolio advances the company’s efforts to support
overall patient management by providing solutions that enable
efficiencies in critical care.
“Baxter’s agreement with bioMérieux will allow us to introduce a
new diagnostic offering to our Acute Therapies portfolio and offer
clinicians a meaningful tool as they manage the complexities of AKI
in their patients,” said Reaz Rasul, general manager of Baxter’s
Acute Therapies business.
AKI is a potentially life-threatening condition where the
kidneys suddenly stop working, often as the 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. AKI is an increasingly common
complication of acute illnesses in intensive care units and
hospitals.1 2 3 The ability to predict persistent severe AKI could
help physicians determine which patients are likely to recover on
their own and which patients may require more intensive management,
including evaluation of renal replacement therapy (“dialysis”) to
replace the function of the kidneys.4 Currently, physicians are
evaluating the likelihood of renal recovery and making decisions on
when to initiate renal replacement therapy with conventional
markers such as creatinine and urine output, which have well-known
limitations.
“bioMérieux continues to focus on high-medical-value diagnostics
which directly benefit patients and improve their healthcare. The
development of the NEPHROCLEARTM CCL14 test is consistent with our
mission to aid in the care of individuals with acute medical and
critical conditions like AKI and complements our existing
pioneering assays for these types of patients such as procalcitonin
(PCT) and NEPHROCHECK®,” said Mark Miller, executive vice president
and chief medical officer at bioMérieux.
Role of CCL14 Biomarker in Predicting Persistent AKI
A recent study published in Intensive Care Medicine found that
urinary CCL14 (C–C motif chemokine ligand 14), the novel biomarker
measured by the NEPHROCLEARTM CCL14 test, is the most predictive of
persistent stage 3 AKI, the most severe form of AKI,5 when compared
with other AKI biomarkers (NGAL, CHI3L1, L-FABP, Cystatin C,
Proenkephalin, KIM-1 and IL-18).6 The multi-center international
prospective observational study, titled “Identification and
validation of biomarkers of persistent acute kidney injury: the
RUBY study,” enrolled 364 patients in the intensive care unit with
moderate or severe AKI (KDIGO stage 2 or 3), of whom 331 were
available for the primary analysis. In the analysis cohort, 110
patients (33%) met the criteria for persistent stage 3 AKI.
The study considered a broad set of potential biomarkers that
were measured in urine and/or plasma by technicians blinded to
clinical data. The study authors used the area under the receiver
operating characteristic curve (AUC), which summarizes the overall
accuracy of a diagnostic test, to assess the predictive ability of
the biomarkers. They found that the CCL14 biomarker had an AUC (95%
CI) of 0.83 (0.78–0.87),6 which can be considered excellent7 and
was significantly (p<0.05) greater than values for the other
biomarkers tested.6
The NEPHROCLEARTM CCL14 test is not currently approved for use
in Europe or the United States.
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 more than 85 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.
This release includes forward-looking statements concerning the
NEPHROCLEARTM CCL14 test, including potential benefits associated
with the investigational 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: ability to maintain supply
continuity; actions of regulatory bodies and other governmental
authorities; contractual requirements, 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.
1 Siew ED, Davenport A: The growth of acute kidney injury: a
rising tide or just closer attention to detail? Kidney Int
2015;87:46-61.
2 O’Connor ME, Kirwan CJ, Pearse RM, Prowle JR: Incidence and
associations of acute kidney injury after major abdominal surgery.
Intensive Care Med 2016;42:521-530.
3 Susantitaphong P, Cruz DN, Cerda J, Abulfaraj M, Alqahtani F,
Koulouridis I, Jaber BL: World incidence of AKI: a meta-analysis.
Clin J Am Soc Nephrol 2013;8:1482-1493.
4 Chawla LS, Bellomo R, Bihorac A, et al. Acute Disease Quality
Initiative W (2017) Acute kidney disease and renal recovery:
consensus report of the Acute Disease Quality Initiative (ADQI) 16
Workgroup. Nat Rev Nephrol 13(4):241–257.
https://doi.org/10.1038/nrneph.2017.2
5 Kidney International Supplement (2011). 2012 Mar; 2(1):
19–36.
6 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
7 Mandrekar, Jayawant N. Receiver Operating Characteristic Curve
in Diagnostic Test Assessment. Journal of Thoracic Oncology
2010;5:1315-1316.
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Media Contact Andrea Johnson, (224) 948-5353
media@baxter.com
Investor Contact Clare Trachtman, (224) 948-3020
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