Biocartis announces development of Idylla™ COVID-19 test

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 5 September 2017 and is being designed to detect SARS-CoV-2 from respiratory samples such as nasopharyngeal swabs. Subject to a successful ‘Emergency Use Authorization’ 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 test (6), developed in collaboration with Immunexpress Pty Ltd (‘Immunexpress’), that distinguishes sepsis from non-infectious SIRS (systemic inflammatory response syndrome) and provides actionable results in about one hour (7). On 26 March 2020, Biocartis announced that it would lead the commercialization of this test in Europe as the exclusive distributor, while Immunexpress will lead commercialization in the US.

Herman Verrelst, Chief Executive Officer of 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.”

About Biocartis

Biocartis (Euronext Brussels: BCART) is an innovative molecular diagnostics (MDx) company providing next generation diagnostic solutions aimed at improving clinical practice for the benefit of patients, clinicians, payers and industry. Biocartis' proprietary MDx Idylla™ platform is a fully automated sample-to-result, real-time PCR (Polymerase Chain Reaction) system that offers accurate, highly reliable molecular information from virtually any biological sample in virtually any setting. Biocartis is developing and marketing a continuously expanding test menu addressing key unmet clinical needs, with a focus in oncology. This represents the fastest growing segment of the MDx market worldwide. Today, Biocartis offers tests supporting melanoma, colorectal and lung cancer. More information: www.biocartis.com.

Biocartis and Idylla™ are registered trademarks in Europe, the United States and other countries. The Biocartis and Idylla™ trademark and logo are used trademarks owned by Biocartis. This press release is not for distribution, directly or indirectly, in any jurisdiction where to do so would be unlawful. Any persons reading this press release should inform themselves of and observe any such restrictions. Biocartis takes no responsibility for any violation of any such restrictions by any person. Please refer to the product labeling for applicable intended uses for each individual Biocartis product. This press release does not constitute an offer or invitation for the sale or purchase of securities in any jurisdiction. No securities of Biocartis may be offered or sold in the United States of America absent registration with the United States Securities and Exchange Commission or an exemption from registration under the U.S. Securities Act of 1933, as amended.

Forward-looking statements

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(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