-
- 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
- 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†
- 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
- 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
| OGD-500
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
Direct-to-Consumer Benefits
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*
Proven technical performance*
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 |
✔ |
View donor user instructions
Performance characteristics**
OGD-500 |
Yield (µg) |
Concentration (ng/µl) |
A260/280 ratio |
|---|---|---|---|
Mean ± SD |
58.5 ± 47.0 |
68.1 ± 55.3 |
1.7 ± 0.1 |
Median |
48.4 |
55.3 |
1.7 |
95% of samples |
≥ 13.1 |
≥ 16.0 |
1.5 – 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
Protocols
Scientific Posters
User Instructions
User Instructions
Safety Data Sheets
Safety Data Sheets
Accessories
The collection protocol is very convenient, the extraction is very quick and simple, and the yield is great. We have collected from [donors] not willing to go for a blood draw, [including] children, elderly patients and overseas relatives. The ease of shipping and self-collection are remarkable.
Ruth McPherson, MD, PhD and Nihan Kavaslar, PhD
University of Ottawa Heart Institute
Overcoming challenges in DNA sample collection.
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