Oragene•Dx 1mL Sample Collection Kit

High DNA yield and stability ideal for clinical diagnostics, research and banking.

Ideal for self-collection
1ml saliva sample

Product Benefits:

• Painless, non-invasive collection
• Median A260/280 of 1.7 ‡
• Easy collection and transportation
• Oragene•Dx/saliva samples are stable for long-term room temperature storage
• Standardized tube format is compatible with automated processing equipment
• Oragene•Dx solution is bacteriostatic
• Intended for use with molecular diagnostic applications †
• Integrated barcode on tube for 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†

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.

Benefits for the patient:

• Improved patient care, convenience and compliance with easy-to-use saliva based DNA sample collection
• Option to collect in clinic, at point-of-care, or at home with self-collection kits
• Oragene™•Dx and ORAcollect™•Dx saliva kits collect superior samples from all patients, including children or patients that have difficulty with traditional collection methods

Benefits for the lab:

• DNA Genotek’s sample collection products are validated to perform on a wide range of downstream in vitro diagnostic tests
• Increase efficiency, minimize sample handling and reduce handling errors with compatible formats for high-throughput processing
• Lab integration services available to optimize sample processing and reduce validation time and costs for genetic testing

Benefits for the test manufacturer:

• Speed time to market by leveraging FDA cleared DNA Genotek products and decrease overall cost structure
• High-quality biological sample collection products that are scientifically validated
• Access patient samples at point-of-care and eliminate the need for phlebotomy costs and infrastructure
• Improve efficiency, cut costs and increase the number of tests conducted by offering a completely non-invasive, regulatory compliant and easy-to-use saliva sample collection kits
• Leverage experience and expertise in customization , lab integration and sample management through DNA Genotek products and services

There is a rising global popularity of genetic testing, among healthcare professionals, academics, researchers, and lately consumers looking to improve health outcomes through personalized medicine. Use Oragene™•Dx and ORAcollect™•Dx saliva collection kits to collect high-quality DNA saliva samples in order to power Next Generation Sequencing (NGS) technologies for in vitro diagnostics and therapeutic health services.

Join our customer base of thousands using DNA Genotek, who offer a wide assortment of molecular diagnostic services including gene expression profiling, microarrays, CNV/SNP typing, pathogen detection, infectiou disease testing, pharmacogenetic testing, sample banking, assays for personalized medicine and custom diagnostics.