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Biocartis Group N.V.. (7/12/17). "Press Release: Biocartis’ Idylla Instrument and Idylla Console Exempt from US FDA 510(k) Notification Requirements". Mechelen.

Region Region United States (USA)
Organisations Organisation Biocartis Group N.V. (Euronext Brussels: BCART)
  Group Biocartis (Group)
  Organisation 2 FDA (US Food and Drug Administration)
  Group United States (govt)
Products Product Idylla™ molecular diagnostics system
  Product 2 Janssen Idylla™ Respiratory (IFV-RSV) Panel test
Persons Person Sikri, Vishal (Biocartis 201704– General Manager of Biocartis US before Sysmex Inostics + Sysmex + Abbott)
  Person 2 Degrave, Renate (Biocartis 201611 Manager CorpComm + IR)
     


Biocartis Group NV (‘Biocartis’ or the ‘Company’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announces that on 11 July 2017 the US FDA1 published a final list of devices that it has exempted from 510(k) premarket notification requirements in accordance with the US 21st Century Cures Act (signed into US law 13 December 2016). The product codes applicable to the Biocartis Idylla™ Instrument and Idylla™ Console are included on this list. Consequently, Biocartis’ Idylla™ Instrument and Idylla™ Console are no longer subject to 510(k) notification requirements prior to being placed on the US market for in vitro diagnostic use with FDA approved or cleared assays. All other US 510(k) requirements, including current Good Manufacturing Practices (cGMP) and vigilance reporting, remain in effect. With this exemption in place, Biocartis is complying with the instructions in the publication and can now withdraw the pending 510(k) submission for the Idylla™ Instrument and Idylla™ Console.

Vishal Sikri, General Manager of Biocartis US, reacted: “The publication of this list by the US FDA will allow us to speed up the introduction of our fully automated Idylla™ platform in the US. This positive news is one more step towards our vision of bringing high value, rapid molecular diagnostic testing to hospitals in the US.”

Today’s announced exemption does not change the ongoing undertaking of Biocartis and its strategic partner Janssen Diagnostics to obtain 510(k) clearance for the Janssen Idylla™ Respiratory (IFV-RSV) Panel test.


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More information:

Renate Degrave
Manager Corporate Communications & Investor Relations Biocartis
email rdegrave@biocartis.com
tel +32 15 631 729 | mobile +32 471 53 60 64
Twitter: @Biocartis_ | LinkedIn: www.linkedin.com/Biocartis


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 launched the Idylla™ platform in September 2014. Biocartis is developing and marketing a rapidly expanding test menu addressing key unmet clinical needs in oncology and infectious diseases. These areas represent respectively the fastest growing and largest segments of the MDx market worldwide. Today, Biocartis offers ten oncology tests and two infectious disease tests in Europe. More information: www.biocartis.com. Press Photo Library available here. Follow us on Twitter: @Biocartis_.


Biocartis trademark and logo are trademarks belonging to Biocartis and are used and registered in Europe. Idylla™ is a registered trademark in the United States and other countries. Idylla™ trademark and logo are used trademarks belonging to Biocartis. The Idylla™ platform is CE-marked and is for sale in the US. Due to regulatory restrictions, not all of the products may be available in all countries. Please refer to the package insert for applicable intended uses for each individual product.


Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections concerning future events such as the Company's results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.


1 US Food and Drug Administration.

   
Record changed: 2017-07-20

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