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BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray® Torch, the New High Throughput FilmArray® System with FilmArray® Respiratory Panel

Marcy l’Etoile, France - January 12, 2016 – bioMérieux, a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular biology affiliate, has submitted the FilmArray® Torch to the U.S. Food and Drug Administration (FDA) for special[1] 510(k) clearance for use with the FilmArray® Respiratory Panel (RP).

 

The FilmArray® Torch is the latest advancement in syndromic infectious disease molecular testing from BioFire Diagnostics. Providing up to six times more sample throughput per square foot of benchtop space, the high throughput FilmArray® Torch is a fully integrated, random and continuous access multiplex PCR[2] system, designed to meet the throughput demands of any size hospital laboratory.

 

Scalable by design, the 2-module base configured FilmArray® Torch is capable of testing up to 42 patient samples per day, while the 12-module, fully configured FilmArray® Torch is capable of testing up to 262 patient samples per day[3].

 

With intuitive instrument control, an integrated barcode scanner, touchscreen interface, and FilmArray® Link technology, the FilmArray® Torch delivers an optimized user experience and seamless integration into laboratory information systems.

 

This submission highlights our continued effort to provide our customers with the most innovative molecular infectious disease diagnostic solutions,” said Randy Rasmussen, CEO of BioFire Diagnostics. “The FilmArray® Torch delivers the high sample throughput our customers demand without requiring them to sacrifice valuable benchtop space.

 

The 510(k) submission seeks authorized use of the FilmArray® Torch with the existing FilmArray® RP. The FilmArray® RP is a comprehensive panel of 20 respiratory viruses and bacteria in a single test that is performed directly on nasopharyngeal swab-associated viral transport media. “In only 4 years, the FilmArray® RP has become the standard of care in the diagnosis of upper respiratory tract infections – it has fundamentally changed the way clinicians diagnose patients,” added Randy Rasmussen.

 

BioFire announced its intention to seek 510(k) clearance of the FilmArray® Torch for use with all existing FDA-cleared FilmArray® panels in the coming weeks. Additional panels include: the FilmArray® Blood Culture Identification Panel, the FilmArray® Gastrointestinal Panel and the FilmArray® Meningitis/Encephalitis Panel.

 

FilmArray® is a multiplex PCR system that integrates sample preparation, amplification, and pathogen detection into one closed system. The FilmArray® requires only two minutes of hands-on time and has a total run time of about an hour. At the end of September 2015, the global FilmArray installed base in clinical labs increased to about 2,000 systems while revenue nearly doubled underscoring the rapid adoption of syndromic infectious disease testing in the U.S..



[1] The "Special 510(k): Device Modification" utilizes the design control requirement of the Quality System Regulation (21 CFR 820) and may be submitted for a modification to a device that has been cleared under the 510(k) process.

[2] Polymerase Chain Reaction.

[3] Based on a 24 hour day.

 

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595 Anglum Road
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MA 02142-1407, USA Cambridge
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North America

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Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
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Phone : +1 630 628 6055
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bioMérieux, Inc. - Main Building
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Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

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1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

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North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

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North America

bioMérieux, Inc. - Main Building
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Fax : +1 800 968 9494

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Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
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Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
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IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

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North America

bioMérieux, Inc. - Main Building
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Phone : +1 919 620 2000 or +1 800 682 2666
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bioMérieux, Inc. - CSC Building
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Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Dubai
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Finland
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

France
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Germany
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Greece
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Hungary
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Italy
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Netherland
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Norway
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Poland
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Portugal
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Russia
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Serbia
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Spain
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Sweden
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Turkey
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

United Kingdom
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

Australia
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

New Zealand
North America

bioMérieux, Inc. - Main Building
100 Rodolphe Street
Phone : +1 919 620 2000 or +1 800 682 2666
Fax : +1 800 968 9494

bioMérieux, Inc. - CSC Building
1101 Hamlin Road
Phone : +1 800 682 2666 or +1 919 620 2000
Fax : +1 800 968 9494

bioMérieux INDUSTRY - St. Louis Office
595 Anglum Road
Phone : +1 314 731 8500 or +1 800 634 7656
Fax : +1 314 731 8678

bioMérieux, Inc. Cambridge office
5 Cambridge Center, Suite 0802
MA 02142-1407, USA Cambridge
Phone : +1 617 679 8000
Fax : +1 617 679 8050

bioMérieux, Inc. - Lombard
1105 North Main Street
IL 60148-1360 Lombard
Phone : +1 630 628 6055
Fax : +1 630 628 6315

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