Biocartis Group NV: Biocartis' Idylla(TM) Instrument and Idylla(TM) Console exempt from US FDA 510(k) notification requirements
(Thomson Reuters ONE) -
PRESS RELEASE: 12 July 2017, 07:00 CEST
Biocartis' Idylla(TM) Instrument and Idylla(TM) Console exempt from US FDA
510(k) notification requirements
Mechelen (Belgium), 12 July 2017 - Biocartis Group NV ('Biocartis' or the
'Company'), an innovative molecular diagnostics company (Euronext Brussels:
BCART), today announces that on 11 July 2017 the US FDA[1] published a final
list of devices that it has exempted from 510(k) premarket notification
requirements in accordance with the US 21(st) Century Cures Act (signed into US
law 13 December 2016). The product code applicable to the Biocartis Idylla(TM)
Instrument and Idylla(TM) Console is included on this list. Consequently,
Biocartis' Idylla(TM) Instrument and Idylla(TM) 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(TM) Instrument and Idylla(TM) 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(TM) 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(TM) Respiratory (IFV-RSV) Panel test.
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More information:
Renate Degrave
Manager Corporate Communications & Investor Relations Biocartis
email rdegrave(at)biocartis.com
tel +32 15 631 729 | mobile +32 471 53 60 64
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(TM) 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(TM) 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: (at)Biocartis_.
Biocartis trademark and logo are trademarks belonging to Biocartis and are used
and registered in Europe. Idylla(TM) is a registered trademark in the United
States and other countries. Idylla(TM) trademark and logo are used trademarks
belonging to Biocartis. The Idylla(TM) 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.
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[1] US Food and Drug Administration.
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Biocartis Group NV via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 12.07.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 551953
Anzahl Zeichen: 7330
contact information:
Town:
Mechelen
Kategorie:
Business News
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