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BioMérieux Sees Broad Test and Tools Portfolio as Advantage in Sepsis Dx Market

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NEW YORK (GenomeWeb) – Helping clinicians effectively respond to the threat of sepsis sits at the core of BioMérieux's strategy to provide effective diagnostic tools and tests for infectious diseases, as was evident by comments and presentations given by the company's executives earlier this month at the American Association for Clinical Chemistry Annual Scientific Meeting & Clinical Lab Expo in Philadelphia.

BioMérieux provides an array of options based on molecular technology, procalcitonin biomarkers, and MALDI-TOF mass spectrometry that enable physicians and laboratorians to not only identify pathogens leading to sepsis, but also to better understand how well a patient is responding to therapies and whether they should even be given antibiotics.

"One main theme is that it is technically and generally very difficult to create diagnostics for infectious diseases," Mark Miller, BioMérieux's chief medical officer, told GenomeWeb. "These are complex diseases. The pathogens are complex, often multiple, and diagnosis really requires expertise."

Sepsis is life threatening and presents a unique challenge for physicians who need to identify it early and then decide what they can do to help patients survive.

"We consider sepsis to be extremely important," Miller said during a company presentation at AACC. "It's important for the healthcare system, for patients, and for BioMérieux, because we want to supply the tools that are necessary to allow the healthcare system, the physicians, the labs, and the hospitals to be able to care for these patients."

Of all in-patient conditions in the United States, septicemia is among the most expensive. "It is extreme, costing $20.3 billion in 2011 — and probably more today — representing 5.2 percent of total inpatient costs," Miller said, "and that's a place where most people start because the healthcare system is challenged by costs."

A number of competitors are in the market with tests based on varying technologies, including Roche Diagnostics, Abbott, T2 Biosystems, and others.

For the patient, being diagnosed with sepsis is an emotional and generally difficult time, Miller said. Physicians are challenged with differentiating patients with sepsis or septic shock from those with related conditions such as systemic inflammatory response syndrome.

Setting healthcare costs and reimbursement issues aside, "The goal is the same for everybody," Miller said. "Ultimately, the objective is to save lives."

"BioMérieux doesn't just sell PCT biomarker tests or blood culture tests for sepsis," Miller said. "We have a very complete toolbox that allows hospitals, healthcare systems, and clinicians to address the entire sepsis spectrum, and provide tools necessary to help them make decisions."

The firm provides tools for the key steps in sepsis detection, including specimen collection, sepsis diagnosis, direct examination, bacteria isolation, pathogen identification, and antimicrobial susceptibility testing.

For specimen collection, clinicians have a choice between the company's Virtuo, which is pending 510(k) clearance by the US Food and Drug Administration, and the BacT-Alert, suitable for collecting an array of microorganisms, including bacteria, fungi, and mycobacteria. For sepsis diagnosis the company provides the FilmArray syndromic molecular test with multiple arrays, and the Vidas BRAHMS PCT procalcitonin biomarker test, as well as MALDI-TOF mass spectrometry that identifies pathogens to confirm bacterial infections by determining the chemical structure of a molecule through analysis of its mass and the charge of its ions.

Just last month BioMérieux received FDA 501(k) clearance for the expanded use of its Vidas BRAHMS PCT assay for managing sepsis patients with elevated risk of mortality.

The test, originally approved for use in patients in the first day following admission to an intensive care unit, was cleared for monitoring PCT levels over 96 hours to help physicians make treatment decisions for high-risk sepsis patients. The assay, which runs on BioMérieux's fully automated Vidas instrument, is designed to measure changes in blood levels of procalcitonin and can differentiate bacterial from viral infections.

"We can now say that when you look at PCT levels on day four and compare it to when the patient walks in for testing, this is a fantastic measure of how the patient is doing on top of the indications you already have in front of you," Miller said.

Complementing the PCT biomarker test in its product portfolio, BioMérieux's BioFire FilmArray is a fully automated molecular testing system that uses PCR and melt-curve analysis and simultaneously tests for multiple infectious agents in a single panel from a positive blood culture and in about an hour. FilmArray tests for 27 targets, including gram positive bacteria, gram negative bacteria, yeast, and antibiotic resistant genes.

In 2014, BioMérieux acquired the test by completing the purchase of BioFire Diagnostics for $450 million in cash and BioFire's net debt of about $35 million.

BioFire's first commercial test, the FilmArray Respiratory Panel, received 510(k) clearance from the US Food and Drug Administration in 2011 for the simultaneous detection of 15 respiratory viruses. A year later, the FDA granted 510(k) clearance for five additional pathogens.

The PCT biomarker test and FilmArray are complementary to each other, Miller said. "We get a lot of requests for clinical trials [that use both tests]," he explained. "When we acquired BioFire and the respiratory panel was available, we got a lot of calls from people saying that we would love to do a prospective trial of PCT with BioFire FilmArray panels, because each of them gives information and the two of them together are unbeatable."

FilmArray gives you the biggest bang for the buck in terms of looking for all the pathogens you want in the quickest amount of time and in the easiest way possible, he said. PCT looks at infections and various conditions from the host side, from the viewpoint of how the host is responding.

BioMérieux said it believes it can eventually have six panels that are FDA cleared for FilmArray. Its respiratory, blood culture identification, gastrointestinal, and meningitis test panels have already been cleared by the FDA, while lower respiratory and febrile infant test panels are in development.

The firm is also developing a molecular immunosuppression biomarker assay, currently for research use only, that is based on an evaluation of the association between CX3CR1 messenger RNA expression and mortality in patients who are in intensive care for sepsis.

And the company has an agreement with Astute Medical to develop and market the Vidas NephroCheck, an assay to assess the risk to sepsis patients of developing acute kidney injury (AKI). According to the firm, sepsis leads to AKI in 32.4 percent of patients.

"The AKI biomarkers are FDA cleared on the Astute platform," Miller said. "We are now modifying that test to go on our Vidas platform. We have tens of thousands of Vidas platforms in the world, so adapting the assay onto Vidas would allow us to have it available in many countries around the world, and with many hundreds of thousands of patients right away." 

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