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Applied BioCode Obtains FDA Clearance of the Roche MagNA Pure 96 Extraction System for its Gastrointestinal Pathogen Panel

SANTA FE SPRINGS, Calif.–(BUSINESS WIRE)–Applied BioCode announced today that it has received U.S. Food and Drug
Administration 510(k) clearance for the use of the Roche MagNA Pure 96*
Extraction System with the high throughput BioCode® MDx-3000 and
Gastrointestinal Pathogen Panel (GPP).

The BioCode® Gastrointestinal Pathogen Panel and BioCode® MDx-3000
System recently received U.S. Food and Drug Administration 510(k)
clearance, using the bioMerieux NUCLISENS® easyMAG® extraction system.
Now, with the addition of the MagNA Pure 96 System, Applied BioCode will
have access to higher volume laboratories that utilize the Roche system
for sample extraction. The MagNA Pure 96 System can extract DNA/RNA from
up to 96 patient samples in approximately 60 minutes. The combination of
the BioCode® MDx-3000 system and the Roche MagNA Pure 96 System will
allow laboratories to easily process up to 188 patient samples in a
single, 8-hour shift.

The comprehensive BioCode® Gastrointestinal Pathogen Panel provides
results for the 17 most common bacteria, viruses, and parasites that
cause infectious diarrhea. The panel includes targets for bacteria: Campylobacter
(C. jejuni and C. coli)
, Clostridium difficile toxin A&B, Salmonella
spp.
, Shigella/Enteroinvasive E. coli, Shiga-like
toxin producing E.coli, E. coli O157, Enterotoxigenic E.coli,
Enteroaggregative E. coli, Vibrio parahaemolyticus, Vibrio
spp. (including Vibrio vulnificus and Vibrio cholerae), Yersinia
enterocolitica
, viruses: norovirus group I/II, adenovirus 40/41,
rotavirus A, and parasites: Giardia lamblia, Cryptosporidium
(C. hominis and C. parvum)
, Entamoeba histolytica.

The BioCode® MDx-3000 system offers the high volume laboratory an
alternative to high cost, single use, cartridge-based molecular test
systems. This user-friendly automated system also offers target masking
capabilities within panels to address variation in test ordering
patterns and potential changes in panel reimbursement. The BioCode®
MDx-3000 system has the capability to process up to 3 different
multiplex panels on the same run. It also offers a User Defined Mode
where laboratories can develop their own multiplex assays to run on the
system.

The BioCode® Gastrointestinal Pathogen Panel was the first of many
syndromic infectious disease panels developed for the BioCode® MDx-3000
System. Applied BioCode also has a 20-plex Respiratory Pathogen Panel**
completing Clinical Trials for the US market.

* The MagNA Pure 96 System is a product of F. Hoffmann-La Roche Ltd.
**
In clinical trial, has not been cleared by the FDA.

About Applied BioCode, Inc.

Applied BioCode designs, develops, manufactures, and commercializes
multiplex testing products. The company has combined “digital barcodes”
with “immuno- and molecular chemistry” to create a new, bio-inspired
Barcoded Magnetic Beads (BMB) technology. The micro BMB, with a diameter
of human hair, is tagged with immunochemistry or molecular probes,
allowing the digital barcode to be easily scanned and accurately
identified for very high number (4,096 barcodes) of biological targets
with no ambiguity. The company products focus on the molecular
infectious disease segment of the market with assays that detect
pathogens for gastrointestinal infections, respiratory infections,
sexually transmitted infections, and others. Applied BioCode also
partners with a variety of diagnostic companies with applications that
include the infectious disease, autoimmune disease, allergy, gut
microbiome, and veterinary markets. The BioCode® MDx-3000 system with
GPP has obtained the CE-Mark for use in European countries, conforming
to CE-Mark regulations, and is U.S. FDA cleared.

Contacts

Dr. Winston Z. Ho
President, Applied BioCode, Inc.
+1-833-246-2633
[email protected]

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