Superior Point-of-Collection Sampling
& Analyte Preservation Advantages
- SDNA-RUO – For Research Use Only
- SDNA-1000 RX Only – FDA 510k Device Clearance
- SDNA-2000 – OTC Health Canada & CE Clearance
- SDNA-3000 RX Only – Health Canada & CE clearance
- SMD-RUO – For Research Use Only
Innovating Sample Collection, Advancing Saliva Testing
Easily Expanding Testing Access to More Patient Populations
BioMAX® specimen collection devices have been engineered to lead the sampling collection and analyte stabilization market for IVD molecular diagnostic applications. In a demonstration of its superior sample quality, quantity, safety, and point-of-collection innovation, the BioMAX® SDNA-1000 was selected as the first EUA-authorized collection device for COVID-19 saliva diagnostic testing – (Read More). In addition, the SDNA-1000 was also awarded FDA 510k device clearance -(Read More).
- BioMAX® SDNA-RUO – For Research Use Only
- BioMAX® SDNA-1000 – (RX Only) FDA 510k Device Clearance
- BioMAX® SDNA-2000 – OTC Health Canada & CE Clearance
- BioMAX® SDNA-3000 – (RX Only) Health Canada & CE clearance
- BioMAX® SMD-RUO – For Research Use Only
Instrumental in helping to accelerate the scientific journey, the BioMAX® self-contained specimen collection system offers two analyte preservation buffers to choose from based on your testing application. Additionally, the BioMax® device provides critical sample consistency and extended nucleic acid stability at ambient temperatures.
- SDNA (DNA/Viral RNA analyte stabilization)
- SMD (Multi-Omic Proteomic/Genetic analyte stabilization)
Additional BioMAX® Innovation Information:
- BioMAX® SDNA patented buffer provides 10-second in-device live viral neutralization – (Read more) for COVID-19, Flu A, Flu B, and RSV at ambient temperatures, mitigating risk of exposure for patients and downstream processes.
- Spectrum’s BioMAX® saliva collection systems ship with unique barcode serialization.
- Optional customized secondary packaging, clinical kitting, and direct-to-patient fulfillment solutions.
- SDNA Safety Data Sheet – (Download)
- SMD Safety Data Sheet – (Download)
Designed to Eliminate
Self-Collection Errors
User error from the self-collection of saliva samples is one of the most common points of test failure.
Instead of another band-aid, we designed a solution.
Do not eat, drink, chew gum, or smoke at least 30 minutes before collecting your saliva.
Designed to Eliminate Self-Collection Errors
User error from the self-collection of saliva samples is one of the most common points of test failure.
Instead of another band-aid, we designed a solution.
Do not eat, drink, chew gum, or smoke at least 30 minutes before collecting your saliva.
Industry Changing
COVID-19 Saliva Testing
How you collect, preserve, and transport saliva is pivotal. The simplicity and effectiveness of the BioMAX® system delivers a new standard of care for patients and efficiency for laboratories.
- First FDA Authorized COVID-19 saliva testing solution – (Read More)
- First FDA Authorized at-home saliva collection device for COVID-19 testing – (Read More)
- Identify infections at their earliest stage before the onset of symptoms – (Read More)
- In-device 100% inactivation of the live virus within the device at ambient temps – (Read More)
- Maintains critical biosample consistency – (Read More)
- 99.998% testing accuracy & more sensitive – (Read More)
- Post-collection stability with no degradation in sample efficacy – (Read More)
- No temperature-controlled storage or sample transport
- Process multiple tests from a single collected sample
How-To Product
Video Tour
Huge amounts of innovative engineering have been poured into the development of our SDNA saliva collection device. Today its ease of use has been rewriting specimen collection protocols across the nation and worldwide. The intuitive design and minimal steps are a welcomed answer to those seeing clinical study and project failures due to repeat bio-sample self-collection errors from the lack of viable options.
How-To Product
Video Tour
Huge amounts of innovative engineering have been poured into the development of our SDNA saliva collection device. Today its ease of use has been rewriting specimen collection protocols across the nation and worldwide. The intuitive design and minimal steps are a welcomed answer to those seeing clinical study and project failures due to repeat bio-sample self-collection errors from the lack of viable options.
What does technically
superior mean?
What does technically superior mean?
Process 8,000 COVID-19 Tests/day (+variants)
Proof-PointThermo Fisher's Amplitude Solution + the SDNA-1000 expand testing capacity with minimal time, equipment, & staff
“SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to ensure accurate test results”
Saliva is a Better Biosample for Detecting Infection
Proof-PointStudies Echo Rutgers Significant Saliva Findings
Understanding the breakthrough discovery saliva has delivered goes far beyond expanding COVID-19 testing options. It offers the safest & most robust biomaterial for detecting viral infections and mitigates any risk of infection throughout the entire testing process.
Saliva Sample Viability Transport Study
Proof-PointTested in extreme hot and cold temperatures
FDA Expands current EUA to include the at-home collection of saliva samples for COVID-19 testing. Direct-to-patient at-home collection adds testing complexity and risks sample consistency, sample viability, and sample stability. See the stats and specifics behind the FDA EUA authorization.