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  • Products → Human Genomics → Oragene•Dx | OGD-675

    DNA Collection Kits for Diagnostics

    Collect high-quality DNA samples for direct‐to‐consumer genetic testing

    Oragene Dx | OGD-675

    For assisted collection

    Collect high-quality DNA samples for direct‐to‐consumer genetic testing

    Launching a direct-to-consumer service entails implementing a reliable sample collection method, proven science, strong brand differentiation and scalable sample management. Oragene•Dx is an all-in-one system for the collection, stabilization and transportation of DNA from saliva. Use Oragene•Dx to launch and build a flexible and streamlined direct-to-consumer business.

    Overview

    Product Benefits

    • High quality, high quantity DNA†
    • Painless and reliable self collection
    • Long term room temperature sample stability
    • Transport and store at room temperature
    • Integrated 1D barcode + optional 2D bottom barcode for laboratory workflow efficiency

    Direct-to-Consumer Benefits

    • Proven reliable self‐collection at home or healthcare practitioners/physicians office or clinic*
    • Reduce the time and complexity of an FDA submission by leveraging the 510(k) clearance of Oragene∙Dx
    • Decrease cost of sample transport, management and storage with ambient temperature DNA stability
    • Compact and robust design for transport via the postal system enables easy access to customers
    • Increase efficiency and minimize sample handling with a tube format compatible with automated processing
    • Sample ready for transport, storage and processing
    • High-quality DNA proven for use on microarray and sequencing platforms†

    Oragene•Dx is proven for Prescription Use and Direct-to-Consumer (DTC) at home DNA saliva collection. Data obtained from a Saliva Collection Usability Study* (involving 212 naïve, adult, general population donors receiving a typical DTC saliva collection kit including instructions and two-way mailing box for return shipping) revealed the following:

    Proven easy to use*

    • 96.5% of donors agreed or strongly agreed that the instructions were easy to understand
    • 96% of donors understood how to collect their saliva sample properly
    • 99.5% of donors understood how to send the sample back to the laboratory
    • 100% of donors understood where and how to contact technical support for any questions

    Proven technical performance*

    • 95% of samples passed sample weight criteria (between 1-4 mL of total sample volume)
    • 97% of samples had a DNA concentration of 5 ng/μL or more
    • 96% of samples passed DNA sequencing call rate criteria

    Oragene•Dx product features

     
    Oragene®•Dx
    Completely non-invasive
    ✔
    Standardized tube format for automated processing equipment
    ✔
    Sample stability at room temperature
    1 year
    Bacteriostatic solution
    ✔
    Compact format for mailing
    ✔
    Icon link to the complete donor instruction

    View donor user instructions

    See the product up close

    Performance characteristics**

    OGD-675
    Yield (µg)
    Concentration (ng/µl)
    A260/280 ratio
    Mean ± SD
    13.5 ± 8.8
    41.1 ± 24.6
    1.7 ± 0.1
    Median
    11.0
    33.2
    1.7
    95% of samples
    ≥ 3.8
    ≥ 11.2
    1.6 – 1.9

    For in vitro diagnostic use. For collection of human DNA. Oragene•Dx has been cleared for in vitro diagnostic use in the U.S.A.

    † FDA cleared for in vitro diagnostic use for direct-to-consumer applications, K192920.

    * Based upon results derived from The Oragene®•Dx DTC User Comprehension Study, K192920.

    The Oragene®•Dx DTC User Comprehension Study, K192920 was conducted to support a 510(k) submission to FDA. The study was conducted to assess the acceptability of saliva samples collected with the Oragene®•Dx device for a typical direct-to-consumer application. The study demonstrated that customers comprehended the instructions for use provided with the Oragene•Dx device and could successfully provide a saliva sample at home with acceptable quality for use in genotyping.

    Full terms and conditions for all DNA Genotek products are available here.

    DNA Genotek's sample collection devices and nucleic acid stabilization chemistries are protected by issued and pending patents in numerous countries around the world.

    ** Data obtained by testing 450 samples from 245 individuals

    Literature

    Data Sheets

    Data Sheets

    PD-BR-00239: Oragene•Dx (OGD-675) data sheet (pdf)

    Download MK-BR-00035: Launching direct to consumer service of collection of high quality DNA sample for genetic testing.

    PD-BR-00233: Oragene® 600 series product weight and dimensions (pdf)

    PD-HB-00001: Oragene•Dx product handbook (pdf)

    MK-01030: 3 suggestions for improving saliva generation

    MK-00098: Infographic – DNA from saliva vs blood. Who wins the cost battle?

    Protocols

    Protocols

    Laboratory protocols for manual purification of DNA using DNA Genotek's prepIT•L2P DNA extraction kit

    PD-PR-00466: How to obtain a USPS Business Reply Mail (BRM) label artwork for a DNA Genotek two-way mailer box (pdf)

    Videos

    Processing of DNA Genotek saliva tubes on SARSTEDT Lab Automation (copyright SARSTEDT AG & Co. KG).

    Scientific Posters

    Scientific Posters

    MK-00061: DNA from saliva: Oragene®•Dx performance as demonstrated through 510(k) validation studies (pdf)

    User Instructions

    User Instructions

    Complete OGD-675 Collection Instructions

    Safety Data Sheets

    Safety Data Sheets

    PD-MSDS-00017: Oragene•Dx (OGD-675) (pdf)

    Accessories

    Accessories

    Mailing Accessories

    Storage Accessories

    Branding & Packaging

    Barcoding

    This is a truly great product. I have tried many different chemistries to obtain DNA… and I have not seen a better compromise for yield, purity, time to extract and ease of collection than Oragene.

    Mehdi Keddache, Coordinator
    Cincinnati Children's Hospital, DNA Sequencing Services

    DNA from saliva vs. blood

    Who wins the cost battle?

    Overcoming challenges in DNA sample collection.

    Download this research report to help you increase your compliance rate.

    Inside DNA Genotek

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    Contact us

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    Phone

    +1 (613) 723-5757

    Email

    info@dnagenotek.com

    Address

    3000 - 500 Palladium Drive
    Ottawa, Ontario, Canada
    K2V 1C2

    DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc. (NASDAQ: OSUR), focuses on providing high-quality biological sample collection products and end-to-end services for human genomics, microbiome and infectious disease applications. The Company's Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA 510(k) cleared saliva-based DNA collection devices for in vitro diagnostic use. DNA Genotek also offers Research Use Only products to collect and preserve large amounts of DNA or RNA from multiple sample types. DNA Genotek markets its products worldwide and has a global customer base with thousands of customers in over 100 countries.

    © 2022 DNA Genotek Inc., a subsidiary of OraSure Technologies, Inc., all rights reserved.

  • Industry Solutions
    • Human Genomics - Academic Research
    • Human Genomics - Clinical Diagnostics
    • Microbiome - Academic Research
    • Microbiology/Infectious Disease
    • Metabolomics
    • Biobanking
    • Animal
    • H L A Typing
  • Products
    • Human Genomics
      • All clinical DNA collection kits (saliva)
      • All research DNA & RNA collection kits (saliva)
      • DNA Extraction Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
        • HEMAgene | HG-BCD (blood)
    • Microbiome & Metabolomics
      • All Microbiome & Metabolomics Collection kits
      • Microbiome (IVD)
        • Gut
          • NEW OMNIgene•GUT DX | OMD-200 (IVD)
      • Microbiome (Research only)
        • Gut
          • OMNIgene•GUT | OMR-200
          • OMNIgene•GUT | OMR-200+ACP101
          • OMNIgene•GUT | DNA & RNA | OMR-205
        • Oral
          • OMNIgene•ORAL | OM-501 (saliva)
          • OMNIgene•ORAL | OMR-110 (gum/plaque)
          • OMNIgene•ORAL | OMR-120 (tongue)
        • Skin
          • OMNIgene•SKIN | OMR-140
        • Vaginal
          • OMNIgene•VAGINAL | OMR-130
      • Metabolomics
        • Gut
          • OMNImet•GUT | ME-200
    • Infectious Disease
      • COVID-19
        • COVID-19 Collection Kits
        • OMNIgene•ORAL | OME-505 (saliva)
        • ORAcollect•RNA | ORE-100
      • DNA & RNA Collection Kits
        • All DNA & RNA Collection Kits
        • OMNIgene•ORAL | OM-501 (saliva)
        • Colli-Pee | FV-5000 (urine)
      • DNA Extraction Reagents
        • prepIT•L2P | PT-L2P (saliva)
        • prepIT•Q2A | PT-Q2A (saliva)
    • Animal
      • Animal Microbiome
        • PERFORMAbiome•GUT | PB-200
      • Animal Genetics
        • PERFORMAgene | PG-100
    • Customization Options
      • Branding & Packaging
      • Barcoding
    • Accessories
      • Collection
      • Mailing
  • Services
    • Microbiome
      Amplicon and whole genome sequencing and analysis
    • Customization & Fulfillment
      Product customization and direct-to-donor shipments
  • Support
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    • FAQs
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