PRESS RELEASE: 30 November 2021,
SeptiCyte® RAPID Receives 510(k) clearance by
Sepsis is the body’s overwhelming and life-threatening response to infection which encompasses immune system dysregulation and can lead to tissue damage, organ failure, and death3. Today, diagnosing sepsis is challenging because conventional techniques such as blood culture or the detection of sepsis-related biomarkers such as lactate and procalcitonin are slow and often not very accurate4. At the time of treatment, physicians disagree on the right treatment in 40-60% of cases5 because no accurate diagnostics are available to deliver a result at this time, which leads to the widespread overuse of antibiotics3.
SeptiCyte® RAPID6 is a fully automated, rapid host-response7 test that distinguishes sepsis from infection negative systemic inflammation in patients suspected of sepsis. It provides actionable results8 in about one hour, enabling physicians to optimize their patient management decisions.
Herman Verrelst, Chief Executive Officer of
“The 510(k) clearance for SeptiCyte® RAPID comes at the right moment in the COVID-19 pandemic, specifically as winter approaches and various respiratory viruses proliferate. The burden of unceasing COVID-19 related hospitalizations emphasizes the importance of an early and accurate diagnosis of sepsis, especially in intensive care settings where quick action is needed. Moreover, our recent clinical validationstudy9 demonstrates that SeptiCyte® RAPID continues to be more efficient and effective than traditional methods10, which is needed now more than ever," said
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1 Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k)
2 The Idylla™ Instrument and Idylla™ Console have been exempted by the
3
4 Source: https://septicyte.com/wp-content/uploads/2021/09/IMM-013-16x9-04-01-SC24-FINAL.pdf, last consulted on
5 Source: https://immunexpress.com/about-sepsis/, last consulted on
6 SeptiCyte® RAPID is developed by
7 Host-response based tests focus on measuring biomarkers that are indicative of the response of a patient’s immune system to an infection rather than measuring pathogens that are the cause of the infection
8 Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS (Systemic Inflammatory Response Syndrome) but also correlates with viral sepsis infection, versus procalcitonin (PCT) which increases with severity of bacterial but not viral infection and is also a non-specific marker of inflammation
9 Presented during the 2021
10 In a recent study presented by
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