The SARS-CoV-2 test is targeted to help healthcare providers manage COVID-19 pandemic through rapid, easy testing of individuals with flu-like symptoms
Biocartis Group has announced the development of a SARS-CoV-2 test, the virus that causes COVID-19, on the fully automated, rapid and easy to use molecular diagnostics platform Idylla.
Upon regulatory approval, the Idylla SARS-CoV-2 test is targeted to help healthcare providers manage the COVID-19 pandemic through rapid and easy testing of individuals with flu-like symptoms. In addition, the Idylla SARS-CoV-2 test may be used in combination with the recently CE-marked IVD SeptiCyte RAPID Test[1] on Idylla to facilitate the management of patients within the hospital intensive care unit (ICU). When used together, this combined testing solution on Idylla has the unique potential to identify patients with severe disease, as recent data[2] indicate that sepsis is the most frequently observed complication in COVID-19[3]. Biocartis develops the Idylla SARS-CoV-2 test with support from multiple undisclosed partners as part of a joint commitment to respond to the COVID-19 pandemic.
The Idylla SARS-CoV-2 test will be based on the Idylla Respiratory (IFV-RSV) Panel[4] that received 510(k) clearance by the US FDA on September 5, 2017 and is being designed to detect SARS-CoV-2 from respiratory samples such as nasopharyngeal swabs. Subject to a successful ‘Emergency Use Authorisation’ by the US FDA, launch of the Idylla SARS-CoV-2 test is expected in the second half of 2020[5]. The US FDA 510(k) clearance of the SeptiCyte RAPID Test on Idylla is expected along the same timelines.
The SeptiCyte RAPID Test (CE-IVD) on Idylla is a rapid host-response[6] test, developed in collaboration with Immunexpress, that distinguishes sepsis from non-infectious SIRS (systemic inflammatory response syndrome) and provides actionable results in about one hour[7]. On March 26, 2020, Biocartis announced that it would lead the commercialisation of this test in Europe as the exclusive distributor, while Immunexpress will lead commercialisation in the US.
Herman Verrelst, Chief Executive Officer, Biocartis, commented: “Developing a respiratory panel device detecting SARS-CoV-2 on Idylla, especially when used in unique combination together with the Septicyte RAPID Test on Idylla, is expected to address the significant current and longer term unmet needs in hospitals and specifically in ICU’s to more efficiently triage patients with flu-like symptoms. As such, unnecessary ICU admissions could potentially be prevented or average length of hospital stays could be reduced.”
References:
[1] Developed in collaboration with Immunexpress. More info here
[2] Zhou et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study, published online 9 March 2020, https://doi.org/10.1016/S0140-6736(20)30566-3
[3] Sepsis developed at a median of 9 days (7–13) after illness onset among all patients, followed by ARDS (12 days [8–15]), acute cardiac injury (15 days [10–17]), acute kidney injury (15 days [13–19.5]), and secondary infection (17 days [13–9])
[4] Legally acquired in 2018 from Janssen Diagnostics, a division of Janssen Pharmaceutica NV (‘Janssen’) who co-developed the assay Source: https://investors.biocartis.com/sites/default/files/press-releases/2019/170904-PR-510k-clearance-IFV-RSV-Panel-ENG.pdf
[5] Subject to interactions with the US FDA
[6] 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
[7] Moreover, SeptiCyte® RAPID not only discriminates sepsis from SIRS 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
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