Frequently asked questions
Oral Genome is an in-vitro salivary biomarker based test for risk assessment that can be performed both in-office and at-home. It serves as an adjunctive tool that assists dentists with caries risk assessment, caries susceptibility, and periodontal decision-making through the analysis of a saliva sample. The product utilizes both chemical and biological processes to analyze saliva samples for markers that indicate various oral conditions. Additionally, this test aids in the decision-making process for diagnoses and is used to educate on oral systemic conditions, helping to bridge the gap between dental and medical care by facilitating referrals to physicians.
For the analysis and utilization of Oral Genome saliva tests, we recommend several CDT codes based on the specific assessments and results. These include:
D0418: Analysis of a saliva sample
D0425: Caries susceptibility tests
D0601: Caries risk assessment and documentation, with a finding of low risk
D0602: Caries risk assessment and documentation, with a finding of moderate risk
D0603: Caries risk assessment and documentation, with a finding of high risk
D1330: Oral hygiene instructions
Providers using these CDT codes must ensure that they conduct the Oral Genome test comprehensively, discuss the results with their patients, and provide formal diagnostic risk assessments. These assessments should utilize clinical judgment and available evidence to support their use of these codes.
According to the ADA Guide to Salivary Testing, CDT codes enable every dentist to accurately document services delivered in a patient's dental record and reported on a claim. As written in the CDT manual's preface, the presence of a CDT code does not mean that the procedure is covered or reimbursed by a dental plan. Reimbursements for any procedure is determined by the dental benefits plan. Any questions about reimbursements are best addressed by contacting the particular insurance company involved.
D0418: Analysis of a saliva sample
D0425: Caries susceptibility tests
D0601: Caries risk assessment and documentation, with a finding of low risk
D0602: Caries risk assessment and documentation, with a finding of moderate risk
D0603: Caries risk assessment and documentation, with a finding of high risk
D1330: Oral hygiene instructions
Providers using these CDT codes must ensure that they conduct the Oral Genome test comprehensively, discuss the results with their patients, and provide formal diagnostic risk assessments. These assessments should utilize clinical judgment and available evidence to support their use of these codes.
According to the ADA Guide to Salivary Testing, CDT codes enable every dentist to accurately document services delivered in a patient's dental record and reported on a claim. As written in the CDT manual's preface, the presence of a CDT code does not mean that the procedure is covered or reimbursed by a dental plan. Reimbursements for any procedure is determined by the dental benefits plan. Any questions about reimbursements are best addressed by contacting the particular insurance company involved.
Oral Genome is categorized under the FDA’s General Wellness: Policy for Low Risk Devices. This classification means that our product is designed to enhance wellness and provide valuable health insights without requiring FDA premarket approval, typical for higher-risk medical devices. Additionally, while there are currently no dental saliva tests that have received FDA approval as noted by the ADA, we proactively ensure that our production facility operates under stringent EN ISO 13485 and FDA standards. This commitment guarantees that our products meet the highest levels of quality and safety, aligning with our dedication to maintaining the utmost standards of safety and efficacy.
Oral Genome's products are manufactured at a facility that is both EN ISO 13485 and FDA certified, ensuring adherence to the highest standards of quality and safety. We have developed our products in collaboration with a global biomedical technology company known for its advanced in-vitro diagnostic solutions. Our manufacturer is an experienced, large-scale producer of FDA-cleared and CE-marked products, including all of our offerings, which are also manufactured under stringent EN ISO 13485:2016 certifications for sales in Europe and the rest of the world. Our partnership with scientific leaders in diagnostic technology enriches our capability to innovate and deliver reliable products.
Our advanced image processing software is specifically designed to adapt to the wide range of smartphone versions. By implementing a machine learning system, the software continuously evolves and customizes its performance to suit the specific capabilities of your device. The blue placement card, where you position your test card, is meticulously calibrated during production to ensure precise print color matching. For every production batch, we calibrate the print to maintain consistent coloring and RGB values, which our image processing software then interprets with high accuracy. Additionally, each batch of test cards comes with a unique QR code, allowing us to calibrate precisely for each set, ensuring that your test results are as accurate as possible.
At Oral Genome, we prioritize the privacy and security of your data above all. We employ state-of-the-art encryption and robust security protocols to protect your personal and health information throughout every stage of our process. Your data is securely stored on protected servers and is accessible only to authorized personnel who adhere strictly to the highest standards of confidentiality. Furthermore, we comply with all applicable data protection regulations, including HIPAA, to ensure your information is safeguarded. Rest assured, maintaining your privacy is our top priority.
Our image processing software is crafted to address the challenge of accommodating variations in phone versions.
Through the implementation of a machine learning system, the software continuously evolves and customizes its performance for each smartphone.
The blue placement card, where you position your test card, undergoes meticulous calibration to achieve precise print color matching. For every production batch, we meticulously calibrate the print to ensure consistent coloring and RGB values, which are subsequently interpreted by the image processing software.
Additionally, each manufacturing batch is assigned a batch number, enabling us to calibrate with precision for each batch of test cards, thereby ensuring accuracy.
Through the implementation of a machine learning system, the software continuously evolves and customizes its performance for each smartphone.
The blue placement card, where you position your test card, undergoes meticulous calibration to achieve precise print color matching. For every production batch, we meticulously calibrate the print to ensure consistent coloring and RGB values, which are subsequently interpreted by the image processing software.
Additionally, each manufacturing batch is assigned a batch number, enabling us to calibrate with precision for each batch of test cards, thereby ensuring accuracy.
Ordering a test from Oral Genome is simple and straightforward. You can visit our website and navigate to the "Order Now" or "Shop" section, where you’ll find our available saliva test kits. Select the kit that best suits your needs, add it to your cart, and proceed to checkout. You'll be prompted to create an account or log in, after which you can complete your purchase using a secure payment method. Please note that you must be a licensed healthcare provider to order a test from Oral Genome. Once your order is confirmed, your test kit will be shipped directly to your address.
Each Oral Genome test card is viable for approximately two years. To ensure the accuracy and validity of your test, each box is labeled with an expiration date. The QR code on the test card also serves multiple purposes, including verifying test accuracy by identifying the test batch and confirming that it has not expired. This system guarantees that the product you use is effective and reliable up to its labeled expiration date.
No, reusing the test card is not feasible. Our test cards are specifically crafted for one-time use.