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BioCode® MDx-3000

BioCode® MDx-3000

An Automated, High-Throughput Molecular Diagnostic System
Utilizing Unique, Barcoded Magnetic Bead Technology

Providing solutions for a variety of infectious disease testing, ideal for moderate to high volume testing laboratories.

The BioCode® MDx-3000

is a high quality and automated digital multiplex system based on patented Barcoded Magnetic Bead (BMB) Technology, designed to optimize laboratory workflow.

This easy-to-use automated molecular diagnostic system integrates the post extraction processes of molecular diagnostic testing. The BioCode® MDx-3000 system is based on a 96-well microplate format providing cost-effective, high throughput testing. The system automates the PCR amplification, hybridization/target capture and detection steps of molecular testing. Automation, along with a simplified workflow, reduces hands-on time for labor savings and minimizes the potential for sample contamination.

Fluorescence signal from BMBs enables the determination of the presence or absence of various analytes or targets in the patient samples. The micro BMBs, about the diameter of a human hair, are tagged with immunochemistry or molecular probes, allowing the digital barcodes to be easily scanned and accurately identified up to 4,096 barcodes with no ambiguity for biological targets.

  • MDx-3000, Gastrointestinal Pathogen Panel & 17-Plex Respiratory Panel: FDA 510(k) cleared
  • SARS-CoV-2 & SARS-CoV-2 Flu Plus Assays: FDA EUA

TRANSFORMING YOUR EXPERIENCE

FEATURES & BENEFITS

    • Easy-to-use
    • Scalable throughput of up to 188 patient samples in an 8-hr shift
    • Fluorescence signal above cutoff is indicative of presence of a target DNA/RNA in sample
    • Simultaneous testing of up to 3 different panels on a single run
    • Reduce potential errors and accurately detect infection through automation

SMART SYSTEM ARCHITECTURE

    • Data Masking option enables select target reporting based on clinician’s order
    • Custom User Defined Mode supports the use of Laboratory Developed Tests
    • Automated post-run, build-in, sterilization to reduce potential contamination

SIMPLE SYSTEM DESIGN

    • Intuitive user interface with simple configuration options
    • Touchscreen workflow and integrated barcode scanner
    • Automated data management through LIS (Laboratory Information System) connectivity

DETAILS

Select a section below to learn more

HOW IT WORKS

Optically bar-coded beads are mass produced at low cost by well established semiconductor processes. These beads are functionalized with nucleic acids, proteins or other probe molecules, allowing highly multiplexed assays to be carried out in homogeneous or heterogeneous media.

BARCODED MAGNETIC BEAD (BMB) TECHNOLOGY

Over 4,096 barcodes to choose from

“Digital barcodes” combined with “immuno- and molecular chemistry” create a new, bio-inspired Barcoded Magnetic Beads (BMB) technology. This patented BMB with biopolymer composites and multiple layers of structural configuration, allows the barcode (4,096 available barcodes) to be easily scanned and accurately identified with no ambiguity. Because the fluorescence is detected at a steady state, the variation of the fluorescent signal is minimal, which is crucial for quantitative assays, such as protein analysis. This breakthrough technology significantly improves the identification and throughput capacity of in-vitro diagnostics.

Barcoded Magnetic Beads are formed by biocompatible polymer with paramagnetic material composite. Biocompatible polymer enables highly stable surface chemistry; paramagnetic material exhibits magnetic properties when an external magnetic field is applied, allowing for easy washing and separation.

Fluorescence signal above cutoff is indicative of presence of a target DNA/RNA in sample

HIGHLIGHTS

  • Digital Multiplexing: Outperform analog (dye) multiplexing; no microflow cytometer is required
  • Universal Platform: for both proteins and nucleic acids
  • Flexible Targets: Add-on more targets any time
  • Speed: All-in-one assay
  • Batch-to-Batch Consistency: well established and highly reproducible semiconductor process
  • Low Assay Cost: Use ~1/100 of assay (protein) materials compared with conventional ELISA
BMBs in a tube (left) react to a strong magnet (right).

FEATURES

Automation of key system processes (PCR amplification, hybridization/ target capture, and detection) reduces hands-on time and the potential for sample contamination.

• The 96-well microplate format provides a cost-effective alternative to high volume Multiplex testing.

• Throughput: 94 patient samples (94 x 18 = 1,692 data points) can be completed on the BioCode® MDx-3000 system in about 3.5 hours

• The BioCode® MDx-3000 system is user-friendly and takes little operator hands-on time.

• Operators can run the same assay panel or mix up to 3 different assay panels with the same protocols on one plate.

• Operators can program the system to mask results for tests not ordered on the patient.

• The BioCode® MDx-3000 system can be interfaced to your laboratory information system (LIS) to download system worklists and upload patient results.

SYSTEM

The BioCode® MDx-3000 system is an easy-to-use automated molecular diagnostic system that integrates the post extraction processes of molecular diagnostic testing. The BioCode® MDx-3000 system is based on a 96-well microplate format providing cost-effective, high throughput testing.

The BioCode® MDx-3000 system automates the PCR amplification, hybridization/target capture and detection steps of molecular testing. Automation, along with a simplified workflow, reduces hands-on time for labor savings and minimizes the potential for sample contamination. Up to 94 patient samples can be completed on the system in approximately 3.5 hours. Up to 3 different assay panels with the same test protocols can be run on the system at the same time.

The BioCode® MDx-3000 has a “User-Defined Mode” giving operators the ability to program and run Laboratory Developed Tests (LDT) on the system.

SPECIFICATIONS

Communications Interface: Touch screen, keyboard, hand-held scanner
Communications Ports: Ethernet, USB
Power Requirements: 100 – 240V; 50/60Hz
System Dimensions: 42” W x 31” D x 61” H

OPERATION

Nucleic acids (DNA/RNA) are extracted from samples using an automated extraction process.

The Patient Sample Work List is downloaded from the LIS into the BioCode® MDx-3000 or simply input by the operator using a barcode scanner, touch screen, or keyboard.

BioCode® MDx-3000 utilizes a BMB-Probe Mix for detection of all targets. To begin the run, the BMB-Probe Mix barcode is scanned to ensure the correct test panel, lot number, and expiration date are valid.

After the extraction and PCR setup steps are completed, the PCR plate is transferred to the BioCode® MDx-3000.

The operator makes sure all consumables are loaded on the system, closes the system door, initiates auto deck-check, and the run begins.

Walk-away automation; Operators are free to do other laboratory tasks during system operation.

Patient test results are displayed as soon as systems detection step is completed. No additional analysis or interpretation is needed.

WORKFLOW

Step 1:

Automated DNA/RNA extraction.

Step 2:

PCR setup.

Step 3:

Load PCR microplate onto BioCode® MDx-3000. The System automates the PCR amplification, hybridization/target capture, and detection process, and reports the results.

ASSAY PANELS

BioCode® SARS-CoV-2 Assay kit [Catalog no. 64C0304]

Catalog no. 64C0304

For use under the Emergency Use Authorization (EUA) only

The BioCode® SARS-CoV-2 Assay* is a multiplexed nucleic acid test intended for the qualitative detection of SARS-CoV-2 in upper respiratory specimens such as nasopharyngeal swabs (NPS), oropharyngeal swabs (OPS), and nasal swabs or bronchoalveolar lavage (BAL) from individuals who are suspected of COVID-19 by their healthcare provider.

The test is designed to detect two different conserved regions of SARS-CoV-2 N gene. The Assay does not detect common coronaviruses (OC43, HKU1, NL63, and 229E), MERS-CoV, or SARS-CoV.

The BioCode® SARS-CoV-2 Assay can be run as an independent test or in parallel with other FDA-cleared BioCode® assays on the BioCode® MDx-3000 instrument.


Flexible, High Throughput System

• Delivers up to 564 sample results in a day (188 patient samples in an 8-hour shift)
• Pooled testing of up to 5 individual upper respiratory specimens (NPS, OPS, and nasal swabs)
• Parallel testing with other FDA-cleared BioCode® assays


*The BioCode® SARS-CoV-2 Assay has not been FDA cleared or approved; the test has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.
The BioCode® SARS-CoV-2 Assay has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Emergency use of the BioCode® SARS-CoV-2 Assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

BioCode® SARS-CoV-2 Flu Plus Assay kit [Catalog no. 64C0305]

Catalog no. 64C0305

Detect and differentiate four pathogens from one sample, all in one test

The BioCode® SARS-CoV-2 Flu Plus Assay** is a multiplexed nucleic acid test intended for the qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, Influenza B, and/or Respiratory Syncytial Virus (RSV) in nasopharyngeal swabs.

The test is performed on the BioCode® MDx-3000 automated system. It can be run as an independent assay or in parallel with our FDA-cleared BioCode® Respiratory Pathogen Panel for a more complete respiratory infection profile of patients.


Multiplex Panel of Viruses of Respiratory Indications

• Differentiates between SARS-CoV-2, Flu A, Flu B, and RSV
• Identification of influenza A with H1 pdm09, H1 seasonal, H3 subtypes
• Data Masking option enables select target reporting based on clinician’s order ⱡ


BioCode® MDx-3000 Workflow Delivers:

• Flexible sample testing throughput, process up to 188 patient samples in an 8-hour shift
• Reliable and affordable testing


** This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories; This product has been authorized only for the detection
and differentiation of nucleic acid from SARS-CoV-2, Influenza A (with H1 pdm09, H1 seasonal, H3 subtypes), Influenza B and/or Respiratory Syncytial Virus (RSV), not for any other viruses or pathogens; and
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

ⱡ Results must include SARS-CoV-2.

BioCode® Gastrointestinal Pathogen Panel [Catalog no. 63G000]

Catalog no. 63G000

Detect and differentiate 17 pathogens from one sample, all in one test

The BioCode® Gastrointestinal Pathogen Panel (GPP) utilizes proven Barcoded Magnetic Beads (BMB) technology to detect specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of infections. The BioCode® GPP Assay is a flexible, cost efficient, comprehensive molecular test that detects and identifies the 17 most common causative pathogens in raw stool specimens or stool in Cary-Blair medium from symptomatic patients.

The assay can be run as an independent assay or in parallel with our other FDA-cleared BioCode® Assays on the BioCode® MDx-3000 automated system.


Flexible, High Throughput System

• Detect and identify nucleic acids from multiple bacterial, viral and parasitic pathogen targets found in human stool
• Process up to 188 patient samples in an 8-hour shift
• Data Masking option enables select target reporting based on clinician’s order


Pathogens Detected:

Bacteria

  • Campylobacter (C. jejuni/C. coli)
  • Clostridium dificile toxins A and B
  • Escherichia coli O157
  • Enterotoxigenic E. coli LT/ST (ETEC)
  • Enteroaggregative E. coli (EAEC)
  • Salmonella spp.
  • Shiga-like toxin producing
    • E. coli stx1/stx2 (STEC)
  • Shigella/ Enteroinvasive E. coli (EIEC)
  • Vibrio spp.
    • (V. cholerae/ V. parahaemolyticus/ V. vulnificus)
    • Vibrio parahemolyticus
  • Yersinia enterocolitica

Viruses

  • Adenovirus 40/41
  • Norovirus GI/GII
  • Rotavirus A

Parasites

  • Cryptosporidium (C. hominis/ C. parvum)
  • Entamoeba histolytica
  • Giardia lamblia

BioCode® Respiratory Pathogen Panel [Catalog no. 63R0001]

Catalog no. 63R0001

Detect and differentiate 17 pathogens and subtypes from one sample, all in one test

The BioCode® Respiratory Pathogen Panel (RPP) is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with the BioCode® MDx-3000 instrument. The BioCode® RPP is capable 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 assay can be run as an independent assay or in parallel with our other FDA-cleared BioCode® Assays on the BioCode® MDx-3000 automated system.


Flexible, High Throughput System

• Detect and identify 17 microbial pathogens and subtypes
• Process up to 188 patient samples in an 8-hour shift
• Data Masking option enables select target reporting based on clinician’s order


Pathogens Detected:

Viruses

  • Adenovirus
  • Coronavirus (229E, OC43, HKU1, and NL63)
  • Human Metapneumovirus A/B
  • Influenza A (subtypes H1 seasonal, H1 pdm09, and H3)
  • Influenza B
  • Parainfluenza 1
  • Parainfluenza 2
  • Parainfluenza 3
  • Parainfluenza 4
  • Respiratory Syncytial Virus A/B
  • Rhinovirus/Enterovirus

Bacteria

  • Bordetella pertussis
  • Chlamydia pneumoniae
  • Mycoplasma pneumoniae

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