Neonatal sepsis is a leading cause of death for newborns

Testing IL-6 can indicate a neonatal sepsis infection earlier than other biomarkers

Earlier diagnosis of neonatal sepsis can lead to improved outcomes and a reduction of long-term complications from sepsis

Basel, 18 October 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the Elecsys IL-6 immunoassay has become the first IL-6 test to have a certified claim for use in diagnosis of neonatal sepsis, in countries accepting the CE Mark.*

Elecsys IL-6 aids physicians in combating the impact of neonatal sepsis by facilitating an early diagnosis. Early and improved diagnosis can contribute to appropriate use of antibiotics, as well as potentially decreasing mortality rates and mitigating long-term consequences of sepsis.

“Sepsis is one of the leading causes of death in newborns and we need to do everything we can to prevent these deaths," said Matt Sause, CEO of Roche Diagnostics. "Receiving the first approval for IL-6 use with newborns, is a significant step forward in helping clinicians confidently diagnose neonatal sepsis earlier and save more lives.”

Neonatal sepsis is an infection involving the bloodstream within the first four weeks of life and results in high rates of morbidity and mortality. Neonatal sepsis can initially present with subtle signs, but can rapidly progress to multisystem organ failure. Early detection and prompt intervention are essential to prevent severe and life-threatening complications.

Testing IL-6 is suitable for early diagnosis of neonatal sepsis as it increases rapidly in response to infection, much earlier than other markers, making it a better early warning marker of inflammation, infection, or sepsis. With earlier diagnosis, clinicians can make earlier and more appropriate interventions to give neonates the best chance of a positive outcome. The Elecsys IL-6 can help to achieve this with the test only taking 18 minutes to run and only using a small amount of blood.

About neonatal sepsis

Sepsis is a condition that can be caused by bacteria, fungi or viruses in the blood and is the result of the body’s response to infection. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. 20% of deaths worldwide are sepsis-related and patient survival decreases by ~8% with each hour of delay before effective treatment.

The first 28 days of life (the neonatal period) are the most vulnerable time for child survival. Every year, an estimated 2.5 million neonates die in their first month of life, accounting for nearly one-half of deaths in children under 5 years of age. An estimated 375 000 neonatal deaths due to sepsis occurred globally in 2018, which represented 15% of all neonatal deaths, making sepsis one of the leading causes of newborn death.

Newborns often present with non-specific signs and symptoms, which means an early diagnosis of neonatal sepsis can be difficult. Some laboratory tests used in sepsis diagnosis have a low sensitivity, particularly in the early phase of infection. It is also difficult to collect sufficient blood volumes from neonates, especially low birthweight infants, so using a small sample size is important to be minimally invasive to the baby. If a sufficient blood sample cannot be taken, it may lead to low positivity rate in blood cultures. In addition, blood culture results can take up to 48 hours, therefore treatment is often started before results are known.

The prognosis of neonatal sepsis depends on early recognition and appropriate treatment, although signs and symptoms are often nonspecific and may overlap with those of other severe conditions, such as meningitis and pneumonia. These clinical signs include respiratory distress and cyanosis, apnoea, feeding difficulties, lethargy or irritability, and poor perfusion.

About Elecsys IL-6

Elecsys IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum and plasma. This assay is used to assist in identifying severe inflammatory responses in patients. A test takes 18 minutes to run and only needs a sample volume of 30 μL (cobas® e411, e601, e602); or 18 μL (cobas® e402, e801), one of the smallest volumes on the market. The Elecsys IL-6 immunoassay is an electrochemiluminescence immunoassay “ECLIA” and is intended for use on cobas e immunoassay analyzers.

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the twelfth consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2020 employed more than 100,000 people worldwide. In 2020, Roche invested CHF 12.2 billion in R&D and posted sales of CHF 58.3 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan