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Thermo Fisher Scientific Announces Expanded FDA Clearance for its B·R·A·H·M·S PCT Sepsis Biomarker

Thermo Fisher Scientific Inc., the world leader in serving science, recently announced it has received clearance from the U.S. Food and Drug Administration (FDA) that expands the clinical claims of the Thermo Scientific B·R·A·H·M·S PCT (procalcitonin) biomarker assay for sepsis risk assessment. PCT is a sensitive and specific biomarker of systemic bacterial infection. Clinicians can now use B·R·A·H·M·S PCT to help assess the response of septic patients to treatment by comparing a baseline PCT measurement with a PCT value taken on day four. The change in PCT over time, in conjunction with other laboratory findings and clinical assessments aids in assessing the cumulative 28-day risk of mortality for patients with severe sepsis or septic shock who are admitted to the intensive care unit.

A Biomarker for Premature Death

A single blood test could reveal whether an otherwise healthy person is unusually likely to die of pneumonia or sepsis within the next 14 years. Based on an analysis of 10,000 individuals, researchers have identified a molecular byproduct of inflammation, called GlycA, which seems to predict premature death due to infections.

LSI Medience Corporation and Kineticos Sign Agreement Related to the Presepsin Biomarker in Sepsis Management and Treatment

LSI Medience Corporation recently announced that the company has signed an Agreement with Kineticos, a Raleigh-Durham, NC based life sciences consulting company. Kineticos will support LSI Medience in identifying opportunities for Presepsin, a new biomarker in sepsis management, to demonstrate utility in clinical trials.

Rapid Blood Test to diagnose Sepsis at the Bedside Could Save Thousands of Lives, Study Suggests

Researchers at King’s College London have identified a biomarker – a biological ‘fingerprint’ – for sepsis in the blood, and showed it could be possible to diagnose the condition within two hours by screening for this biomarker at a patient’s bedside.

Thermo Fisher Scientific and Siemens Renew Partnership for Improved Detection of Sepsis Using B·R·A·H·M·S PCT Biomarker

Hospital laboratories outside the U.S. can benefit from a continued availability of the B·R·A·H·M·S PCT™ assay on ADVIA Centaur® systems, allowing them to diagnose sepsis early and safely.

Thermo Fisher and Siemens Healthcare Diagnostics renew their non-exclusive, long-term, royalty-bearing agreement for the use of Thermo Fisher’s Procalcitonin (B·R·A·H·M·S PCT™) technology, currently available as an automated immunoassay on the Siemens ADVIA Centaur® XP and CP systems in all countries outside the United States and China. The agreement extends a long-standing relationship between the companies.

ADVIA Centaur® B·R·A·H·M·S PCT™ immunoassay currently offers clinicians an integrated solution for accurately diagnosing sepsis and monitoring response to antibiotic therapy allowing for improved clinical decision making. The ADVIA Centaur® systems have a large global installed base in hospital clinical laboratories.

The PCT biomarker test is the gold standard for the early detection of sepsis in critically ill patients and is recommended to initiate, monitor and discontinue antibiotic treatment in the presence of relevant bacterial infections. Broader availability of PCT testing will lead to improved hospital management and care of patients with sepsis or at high risk of developing it.

“The continuation of our close collaboration with Siemens significantly increases the global reach of this critical biomarker, making it available to a broader patient population,” said Marc Tremblay, president of Thermo Fisher Scientific’s Clinical Diagnostics division. “The key for preventing sepsis is the early diagnosis of infections. Early diagnosis also reduces the health economic burden of sepsis therapy, a medical condition that is still very common today and accounts for hundreds of thousands of deaths each year. Therefore, PCT supports hospitals in optimizing their service levels and cost effectiveness in today’s challenging economic environment.”

The worldwide number of patients affected by sepsis is estimated to be 20 to 30 million annually and claims more lives than bowel and breast cancer combined. Despite advances in modern medicine, including antibiotics and vaccines, sepsis remains the primary cause of death from infection with hospital mortality rates between 30 to 60%1. Hospital costs to treat severe sepsis in the U.S. are estimated at $16 billion dollars annually. Much of this cost is attributed to misdiagnosis or delayed diagnosis, making rapid, more reliable detection a national, if not global, imperative. Research published in Critical Care Medicine showed that each hour of delay in therapy can decrease chances of patient survival by 7.6 percent.

Source: ThermoFisher Scientific