Biomérieux Inc. acquired Astute Medical Inc. last April for a scant $90 million. It markets the U.S. FDA-cleared Nephrocheck test for acute kidney injury (AKI) that it gained from the startup, which had previously been a partner under a deal dating back to 2015.

Now, the Marcy-l'Étoile, France-based company has made a deal with Baxter International Inc. to develop biomarker-based AKI tests that go beyond the critically ill population in intensive care units that Nephrocheck serves. The pair are aiming to create biomarker tests that will diagnose and inform the treatment of AKI, but declined to further specify indications or the financial details of the partnership. Baxter offers a variety of critical care products that are used to treat AKI patients, particularly in dialysis.

Beyond Nephrocheck

"There are many other unmet medical needs in terms of assessing, treating and preventing acute kidney injury, or AKI. One of the questions is: do we have good biomarkers, Nephrocheck or others, for patients that are less critically ill. So, for patients who come into the emergency room, say with high fevers or with congestive heart failure, heart attack or stroke do we have good ways of assessing those patients? Do we have biomarkers that work in less critically ill patients?" Mark Miller, EVP and CMO at Biomérieux, told BioWorld MedTech.

"When somebody does go into acute kidney injury do they actually require dialysis? How long can you wait? What type of injury do they have in their kidney? Is that a temporary injury? Is it a permanent injury? So, there are quite a few unmet medical needs and important AKI questions that we still can't answer," he continued. "There are diagnostic tests that may be able to respond to some of these. Hence the interest in the deal between Baxter and Biomérieux to address those sorts unmet medical needs, to see if we can develop diagnostics for that as well based on the success of Nephrocheck."

Nephrocheck is specifically indicated for adult patients who have had acute cardiovascular and or respiratory compromise in the prior 24 hours and are in the ICU to predict their risk of moderate to mild AKI within the subsequent 12 hours.

The test is based on a pair of biomarkers: IGFBP-7 (Insulin-like Growth Factor-Binding Protein-7) and TIMP-2 (Tissue Inhibitor Metalloproteinases-2). These and other undisclosed potential biomarkers that were in the works at Astute Medical could be integrated into a future test developed by Biomérieux and Baxter.

"We're committed to improving outcomes for critically ill patients across the continuum of care, which includes identifying opportunities to diagnose AKI earlier so a patient can receive the best therapy," said Reaz Rasul, general manager of Baxter's Acute Therapies business. "By working with the team at Biomérieux, we'll be able to combine their expertise in diagnostics with our experience in bringing the latest medical advancements to the ICU."

Acute Therapies was one of the fastest growing businesses for Baxter, offering double-digit growth in 2018. Last year, Baxter had $11.1 billion in revenues, an increase of 4 percent over the prior year. So, any enhancements to this high-growth segment would obviously be welcome.

Value-based diagnostics

Biomérieux's business is split between clinical and industrial applications. Within clinical applications, microbiology is the largest, followed by immunoassays and molecular biology. In diagnostics, its focus is antibiotic resistance with roughly 80 percent of its products devoted to various assessments around that.

The formula seems to be working. Biomérieux had €2.4 billion (US$27.4 billion) in 2018 sales with a growth rate of 9.9 percent. On the R&D front, Biomérieux is quite interested in sepsis, which would be complementary to expanded AKI tests.

"Sepsis is an overwhelming system wide infection that affects organs; it's a kind of a hyper immune response of the body to an infection," said Miller. "Sepsis is associated with AKI in about half of patients. So, sepsis is something that we've always been interested in that we continue to do R&D in. With AKI, there's a really good fit there in terms of helping patients with both the sepsis part and the AKI part."

Biomérieux is also interested in developing additional tests that enable a syndromic approach, enabling physicians to quickly identify the underlying cause in order to treat it correctly. On this front, the company offers a pneumonia test. Pneumonia is one of the most common causes for patients to end up in the hospital – and a significant portion of those patients have sepsis and/or AKI as well.

The company is focused on proving the worth of its tests – and to establish pricing based on the value to patients and institutions, a notion it has distilled into the concept of "value-based diagnostics." Biomérieux devotes much of its clinical trial resources toward demonstrating improvements in patient outcomes, time savings and/or costs – as part of an effort to gain higher reimbursement for more useful tests. Often two assays that run on the same machine will be reimbursed at the same rate, rather than based on their treatment value, noted Miller

"We do believe that diagnostics are undervalued, if you look at the history of diagnostics vs. therapeutics or vaccines. Diagnostics are always considered to be the poor cousin in the family," Miller said. "They're always underappreciated, underfunded, under-resourced and underutilized. With the advent of antibiotic resistance and the reliance on antibiotics stability testing and other testing for pathogens to differentiate between the viral infection and bacterial, where you don't even need an antibiotic, those kinds of issues come to the forefront now."

He concluded, "With AKI and pneumonia, these are areas where we have diagnostics that we didn't before. So, as we develop better and more innovative diagnostics, their value is being more appreciated and the funding is slowly increasing, the appreciation is increasing. But I can't say the value is where it should be."