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The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed in vitro diagnostic test intended for use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection of nucleic acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved in Cary-Blair transport medium obtained from individuals with simptoms of gastrointestinal infection. The following bacteria, parasites, and viruses are identified using the BioCode Gastrointestinal Pathogen Panel: - . Campylobacter (C. jejuni/C. coli) - Clostridium difficile (C. difficile) toxin A/B (Fresh samples only) - l Salmonella spp - Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio parahaemolyticus . - . Yersinia enterocolitica - . Enteroaggregative Escherichia coli (EAEC) - Enterotoxigenic Escherichia coli (ETEC) lt/st - E. coli 0157 serogroup - Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 - Shigella/ Enteroinvasive Escherichia coli (EIEC) - Cryptosporidium spp (C. parvum/C. hominis) - Entamoeba histolytica - Giardia lamblia (also known as G. intestinalis and G. duodenalis) - . Adenovirus F 40/41 - Norovirus GI/GII ■ - . Rotavirus A The BioCode GPP is indicated as an aid in the diagnosis of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. For In Vitro Diagnostic Use Only. For Prescription Use Only. Positive results do not rule out co-infection with organisms not included in the BioCode GPP. The agent detected may not be the definite cause of the disease. Negative results in the setting of clinical illness compatible with gastroenteriis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Adenovinus 40/41, Campylobacter, E. coli 0157, Shigella(EIEC, Yersinia enterocolitica, and Giardia lamblia were established additionally with retrospective clinical specimens. Performance characteristica, Giardia lamblia, Yersinia enterocolitica and Vibrio (V. parahaemolyticus, V. cholerae) were established primarily using contrived clinical specimens.

The BioCode® Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid-based test designed to be used with the BioCode MDx-3000 system. The BioCode MDx-3000 is an automated system that integrates PCR amplification, target capture, signal generation and optical detection for multiple gastrointestinal pathogens from a single stool specimen, either unpreserved or in Cary Blair. Stool specimens are processed, and nucleic acids extracted with easyMAG, MagNA Pure 96, KingFisher Flex and KingFisher Apex Dx. Once the PCR plate is set up and sealed, all other operations are automated on MDx-3000. The BioCode MDx-3000 Gastrointestinal Infection Panel simultaneously tests for 17 pathogens (see table below) from unpreserved stool specimens or stool collected in Cary-Blair transport medium. Results from the BioCode Gastrointestinal Pathogen Panel (GPP) test are available within less than 4 hours.

The BioCode Respiratory Pathogen Panel (RPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BioCode MDx 3000 Instrument. The BioCode of the simultaneous detection and identification of nucleic acids from multiple viruses and bacteria extracted from nasopharyngeal swab (NPS) samples obtained from individuals with signs and/or symptoms of respiratory tract infection. The following pathogens and subtypes are identified using the BioCode RPP: - Adenovirus - · Coronavirus (229E, OC43, HKU1, and NL63) - Human Metapneumovirus A/B - · Influenza A, including subtypes H1, H1 2009 Pandemic, and H3 - Influenza B - Parainfluenza Virus 1 - Parainfluenza Virus 2 - · Parainfluenza Virus 3 - · Parainfluenza Virus 4 - · Respiratory Syncytial Virus A/B - Rhinovirus/Enterovirus - · Bordetella pertussis - Chlamydia pneumoniae - Mycoplasma pneumoniae The detection and identification of specific viral and bacterial nucleic acids from individuals exhibiting signs and/or symptoms of a respiratory infection aids in the diagnosis of respiratory infection if used in conjunction with other clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Negative results in the setting of a respiratory illness may be due to infection with pathogens that are not detected by this test, or lower respiratory tract infection that may not be detected by a nasopharyngeal swab specimen. Positive results do not rule out co-infection with other organisms: the agent(s) detected by the BioCode RPP may not be the definite cause of disease. Additional laboratory testing (e.g. bacterial and viral culture, immunofluorescence, and radiography) may be necessary when evaluating a patient with possible respiratory tract infection. Due to the genetic similarity between Human Rhinovirus, the BioCode RPP cannot differentiate them. A positive BioCode RPP Rhinovirus/Enterovirus result should be followed up using an alternate method (e.g., cell culture or sequence analysis) if differentiation is required. The BioCode RPP detects Human Rhinovirus with reduced sensitivity. If a more accurate Rhinovirus result is required, it is recommended that specimens found to be negative for Human Rhinovirus/Enterovirus after examination using BioCode RPP be confirmed by an alternate method (e.g. FDA cleared molecular tests). Performance characteristics for Influenza A were established when Influenza A H1 2009 Pandemic and A H3 were the predominant Influenza A viruses in circulation. Performance of detecting Influenza A may vary if other Influenza A strains are circulating or a novel Influenza A virus emerges.

The BioCode® Respiratory Pathogen Panel is a respiratory pathogen multiplex nucleic acid test designed for use with the BioCode® MDx-3000 system. The BioCode® MDx-3000 is an automated system that integrates PCR amplification, target capture, signal generation and optical detection for multiple viral and bacterial pathogens from a single nasopharyngeal swab specimen collected in transport media. Specimens are processed and nucleic acids extracted with the NucliSens easyMAG or Roche MagNA Pure 96 automated systems. Once the PCR plate is set up and sealed, all other operations are automated on MDx-3000. The BioCode® RPP simultaneously tests for 17 pathogens and/or subtypes (see table below) from nasopharyngeal swab specimens collected in UTM or VTM. Results from the BioCode RPP test are available within about 5 hours, including off-board nucleic acids extraction.

The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the BioCode MDx 3000 Instrument. The BioCode GPP is capable of the simultaneous detection and identification of nucleic acids from multiple bacteria, viruses, and parasites extracted directly from unpreserved stool samples or stool preserved in Cary-Blair transport medium obtained from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria, parasites, and viruses are identified using the BioCode Gastrointestinal Pathogen Panel: - · Campylobacter (C. jejuni/C. coli) - · Clostridium difficile (C. difficile) toxin A/B (Fresh samples only) - · Salmonella spp - · Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio parahaemolyticus - · Yersinia enterocolitica - · Enteroaggregative Escherichia coli (EAEC) - · Enterotoxigenic Escherichia coli (ETEC) lt/st - · E. coli 0157 serogroup - Shiga-like toxin-producing Escherichia coli (STEC) stx1/stx2 - Shigella/ Enteroinvasive Escherichia coli (EIEC) - · Cryptosporidium spp (C. parvum/C. hominis) - Entamoeba histolytica - · Giardia lamblia (also known as G. intestinalis and G. duodenalis) - Adenovirus F 40/41 - Norovirus GI/GII - Rotavirus A The BioCode GPP is indicated as an aid in the diagnosis of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the BioCode GPP. The agent detected may not be the definite cause of the disease. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Adenovirus 40/41, Campylobacter, E. coli 0157, Shigella/EIEC, Yersinia enterocolitica, and Giardia lamblia were established additionally with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, Giardia lamblia, Yersinia enterocolitica and Vibrio (V. parahaemolyticus, V. vulnificus, and V. cholerae) were established primarily using contrived clinical specimens.

The BioCode Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid-based test designed to be used with the BioCode MDx 3000 system. The BioCode MDx 3000 is an automated system that integrates PCR amplification, target capture, signal generation and optical detection for multiple gastrointestinal pathogens from a single stool specimen, either unpreserved or in Cary Blair. Stool specimens are processed and nucleic acids extracted with the easyMAG and MagNa Pure. Once the PCR plate is set up and sealed, all other operations are automated on MDx 3000. The BioCode MDx 3000 Gastrointestinal Infection Panel simultaneously tests for 17 pathogens (see table below) from unpreserved stool specimens or stool collected in Cary-Blair transport medium. Results from the BioCode Gastrointestinal Pathogen Panel (GPP) test are available within less than 4 hours.

The BioCode Gastrointestinal Pathogen Panel (GPP) is a qualitative, gastrointestinal microorganism multiplexed nucleic acid-based assay capable of detecting of nucleic acids from the following organisms in unpreserved stool and Cary-Blair media: - Adenovirus 40/41 ● - Campylobacter (C. jejuni, C. coli) ● - Clostridium difficile (C. difficile) toxin A/B (from fresh specimens only) ● - Cryptosporidium (C. parvum, C. hominis) 0 - Entamoeba histolytica ● - Escherichia coli (E. coli) 0157 ● - Enterotoxigenic E. coli (ETEC) LT/ST ● - Enteroaggregative E. coli (EAEC) 0 - Giardia lamblia (also known as G. intestinalis and G. duodenalis) ● - Norovirus GI/GII ● - Rotavirus A ● - Salmonella spp. . - Shiga-like Toxin producing E. coli (STEC) stx1/stx2 ● - Shigella (S. boydii, S. sonnei, S. flexneri, S. dysenteriae)/EIEC ● - Vibrio spp. (V. cholerae, V. parahaemolyticus, V. vulnificus), specific identification of V. ● parahaemolyticus - Yersinia enterocolitica The BioCode Gastrointestinal Pathogen Panel (GPP) is indicated as an aid in the diagnosis of specific agents of gastrointestinal illness and results are meant to be used in conjunction with other clinical, laboratory, and epidemiological data. Positive results do not rule out co-infection with organisms not included in the BioCode Gastrointestinal Pathogen Panel (GPP). The agent detected may not be the cause of patient illness. Negative results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn's disease. Concomitant culture is necessary for organism recovery and further typing of bacterial agents. This device is not intended to monitor or guide treatment for C. difficile infection. Due to the small number of positive specimens collected for certain organisms during the prospective clinical study, performance characteristics for Campylobacter spp., E. coli 0157, Shigella/EIEC, Yersinia enterocolitica, and Adenovirus 40/41 were established primarily with retrospective clinical specimens. Performance characteristics for Entamoeba histolytica, and Vibrio spp. (V. parahaemolyticus, V. vulnificus, and Vibrio cholerae) were established primarily using contrived clinical specimens.

The BioCode Gastrointestinal Pathogen Panel (GPP) is a multiplex nucleic acid test designed to be used with the BioCode MDx 300 system. The BioCode MDx 3000 is an automated system that integrates PCR amplification, target capture, signal generation and optical detection for nultiple gastrointestinal pathogens from a single stool speciment or in Cary Blair. Stool specimens are processed and nucleic acids extracted with easyMAG, an automated system. Once the PCR plate is set up and sealed, all other operations are automated on MDx 3000. The BioCode Gastrointestinal Pathogen Panel simultaneously tests for 17 pathogens (see table below) from unpreserved stool specimens or stool collected in Cary-Blair transport medium. Results from the BioCode Gastrointestinal Pathogen Panel test are available within less than 5 hours.