High medical value biomarkers impact how a disease is managed. The introduction of new biomarkers into medical practice can influence patients’ health in many ways. But there is a lot that goes on behind the scenes before research is turned into a diagnostic test that saves lives.
Heart failure (HF) is one of the costliest medical conditions to manage. Its high prevalence, often long hospitalisation stays and frequent readmissions to hospital place a heavy burden on patients, their families and also on healthcare resources.
There had always been an urgent demand for a cost-effective and accurate way to diagnose and manage HF. By 2005, NT-proBNP (N-terminal prohormone of brain natriuretic peptide) as a blood biomarker would fill this gap, becoming a Roche Diagnostics success story. It is an achievement we share with an external partner.
The story begins in the early 1990s. Although Biosite Diagnostics’s BNP assay was already being used in Europe, it was not delivering stable results. The biomarker disappeared too quickly from the blood, causing results to be unreliable. Believing that a better healthcare solution was out there, Roche began tirelessly looking for alternatives.
After vigilant examination of research literature and conference papers, Roche learned in late 1990 of the NT-proBNP biomarker discovery at Oslo’s academic centers. The molecule’s characteristics—including prolonged shelf life, durability and stable levels in blood—could support the typical laboratory workstream. The clinical utility looked promising, persuading Roche to invest in NT-proBNP as a high medical value assay for diagnosing acute HF. To be successful, however, it would need to be a sensitive assay and a means to rule out acute HF, especially for patients in emergency departments.
Following the internal go-ahead from Roche`s medical and development teams, Roche approached the Norwegian Medinnova Foundation (now Inven2), the technology commercialisation arm of the University of Oslo. Roche and Medinnova started to negotiate a license to develop and market their patented NT-proBNP molecule for use on the own cobas immunochemistry analyzers (Elecsys assays). The license agreement was concluded in 1999. After several years of development and heavy investment in clinical studies, Roche launched the Elecsys assay for cobas instruments. A point-of-care assay followed a couple of years later.
On the commercialisation side, Roche also out-licensed NT-proBNP to a number of IVD companies.
As a result of Roche conscious and significant investment in clinical studies and medical education, NT-proBNP is now recommended in major international guidelines (European Society of Cardiology [ESC] Clinical Practice Guidelines and the American AHA/ACC/HFSA Guidelines). After having started as a biomarker for the diagnosis of acute HF, NT-proBNP is now recognized as the gold standard in HF management along the patient journey.1
Today, NT-proBNP is among the most successful assays in Roche’s immunochemistry menu. It is now used all over the world.
This great advance in patient care has been the result of the many years of collaboration—between Roche, Medinnova, and medical experts, as well as double-digit millions in investments—that went into making NT-proBNP the gold standard biomarker of heart failure. Roche’s faith in the convincing research of the University of Oslo did not waver, knowing the assay would soon make a difference to the lives of many people. The symbiotic relationship between Medinnova and Roche has helped millions of patients get the personalised treatment they needed when they needed it.
Roche remains hungry for innovative opportunities and is always on the lookout for new solutions that address unmet medical needs. This is particularly true in the area of heart failure, where Roche continues to be active and is increasing its investment. Roche therefore welcomes new innovative opportunities, new biomarkers and new clinical approaches that can become the future gold standard in heart failure and other highly burdensome diseases. Because they are founded on trust and solid data, partnerships with Diagnostics are built to last. Together, with the sparking of new ideas from outside sources, and Roche’s ability to create and roll out a tool proven to make patients’ lives easier, we can do now what tomorrow’s patients need next.
If you have an opportunity for collaboration or an interesting technology, or if you have an asset in one of our areas of interest, we would like to hear from you.
McKie PM, Burnett JC Jr. (2016) NT-proBNP: The Gold Standard Biomarker in Heart Failure. J Am Coll Cardiol. 2016 Dec 6;68(22):2437-2439.