What scientific standards does IntellxxDNA use when developing its reports?

Scientific curation at IntellxxDNA is led by Sharon Hausman-Cohen, MD, a Harvard-trained physician and researcher. Under her leadership, a multidisciplinary research team with expertise in genetics, molecular biology, microbiology, biomedical science, and scientific research methods continually reviews and curates the scientific literature.

Our goal is identify and prioritize the findings most strongly supported by the best available scientific evidence and most relevant to clinical decision making. This focused approach keeps reports clinically useful and grounded in evidence .

How is the peer reviewed published scientific evidence evaluated?

IntellxxDNA reviews peer-reviewed scientific literature to determine:

• Which health concerns and biological functions are meaningfully associated with each SNP. In making that determination, IntellxxDNA gives greatest weight to high-quality studies with statistically significant findings, meaningful odds ratios or effect sizes, replicated results or support from a strong body of evidence, and a plausible functional effect on biological pathways or gene expression.
• Which health concerns each SNP is meaningfully associated with and how it may affect biological pathways or gene expression. The strength of each SNP’s association with a particular health concern.
• Which interventions are supported by the available evidence and can be linked to the SNP-specific mechanisms and biological pathways associated with a particular health concern.

Which findings meet the evidentiary threshold for clinical decision-making.

When reviewing the scientific literature, the IntellxxDNA research team considers multiple factors to ensure that only high-quality evidence informs the clinical decision support provided to clinicians. These factors include:

• Effect size (such as odds ratios)
• Confidence intervals
• p values, demonstrating strong statistical significance – this means p<0.05 for clinical trials and p<10-8 for GWAS studies.
• Study design and overall quality
• Sample size and statistical power
• Robust beta coefficients
• Replication of findings
• Diversity of the study population, when available
• Clinical relevance and biological plausibility

When multiple studies are available, particularly when their findings may conflict, the IntellxxDNA research team examines the reported data, study design, and methodology to determine which conclusions and genomic associations are best supported by the overall body of evidence. Greater weight is generally given to larger, well-designed studies, the statistical significance of the findings, including the reported p values, and, when available, studies that include more diverse populations.

How are intervention recommendations developed?

Interventions are evaluated independently from SNP associations.

IntellxxDNA prioritizes:

1. Human clinical studies directly linking a genetic variant, biological pathway, and intervention.
2. Human safety and outcomes data are factored into our weighting scales and order of interventions.
3. Human clinical studies demonstrate an intervention's effect on the relevant biological pathway or mechanism.
4. Animal studies when human evidence is not yet available. Note: some animal data is presented by necessity for topics such as traumatic brain injury and stroke due to the difficulties in doing human prospective trials in these populations.
5. Cell studies only when higher levels of evidence do not yet exist. For example: For all interventions unless marked as “research use only” (such as peptides).

Because genomic medicine is an evolving field, direct human studies linking a specific genetic variant, biological pathway, and intervention with concern-specific outcomes -for a particular health concern are not always available. When appropriate, IntellxxDNA identifies interventions - based on the strongest available evidence together with established biological mechanisms.

To keep reports clinically useful, IntellxxDNA prioritizes interventions supported by the strongest available evidence rather than including every intervention mentioned in the literature or supported only by a theoretical rationale.

Can clinicians review supporting research?

Yes. Transparency is a core part of the IntellxxDNA platform. Scientific references supporting SNP interpretations and intervention recommendations are available directly within the platform, allowing clinicians to review the original publications alongside the report findings.

Is the research updated?

Yes. Our research team continually reviews newly published clinical research and updates SNP interpretations, health concern associations, and intervention recommendations as stronger evidence and clinically relevant evidence emerge.

Direct-To-Consumer Genotype Tests

You may have seen commercials for companies that provide DNA tests and health reports to the general public, often piggybacking on the public’s interest in genealogy and ancestry. We appreciate that their marketing efforts have brought the concept of genomics and health into the public eye, however the tests and reports that they deliver to the public are not medically comprehensive. These tests only show variants relayed through selected, single SNPs, which don’t tell the whole story from a clinical perspective.

Whole Genome (WGS) or Whole Exome Sequencing (WES) vs. IntellxxDNA

Some companies offer whole genome sequencing (WGS) or whole exome sequencing (WES). On the surface, sequencing “all of your DNA” may sound like the most complete option. But what does that really mean for the results you receive?

WGS and WES are valuable when the goal is to identify rare genetic diseases or pathogenic mutations. These technologies are particularly good at detecting rare single-gene disorders or large structural changes in DNA, such as insertions, deletions, or repeats. Conditions like Tay-Sachs disease, sickle cell disease, Huntington’s disease, or hereditary breast cancer (e.g., BRCA mutations) are examples where WGS/WES may be useful.

However, WGS and WES are generally not designed to help with common chronic conditions such as cognitive decline, depression, ADHD, cardiometabolic disease, or most forms of autism. These conditions are not caused by a single rare mutation. Instead, they arise from the combined effects of many common genetic variants—none of which are rare—together with environment and lifestyle factors.

That’s where IntellxxDNA is different. Instead of highlighting rare variants you cannot change, our platform focuses on clinically relevant, actionable genetic insights tied to everyday health challenges. IntellxxDNA helps clinicians and patients understand how common genetic patterns influence health, how they interact with lifestyle and environment, and—most importantly—what you can do about them.

IntellxxDNA™ Clinical Tests & Analytic Reports

Created by clinicians for clinicians, IntellxxDNA™ is a clinical decision support tool that provides genomic data and analytics based on gene-to-gene and gene-to-environment interactions through SNP technology.

Whereas most commercial tests focus on just a few alleles or single SNPs, our technology and proprietary methodology dives into the interplay within multiple SNPs, as well as the role that minor alleles play in gene function. IntellxxDNA™’s reporting provides analytics on SNP variables and pairs these findings with odds ratios, a critical factor in clinical decision-making.

IntellxxDNA™’s data and analytics look at the complex intricacies of a patient’s genomic profile and how small variations within their DNA affect their quality of life and health risks. We include evidence-based, well-researched potential intervention strategies – encompassing environment, lifestyle, nutrition, supplements and medications. These components make our reports accessible and actionable for ease-of-use in clinical decision-making.

What information does IntellxxDNA receive about your patients and who is it shared with?

In order to use IntellxxDNA’s services, you (or your practice administration) will arrange for your patient to provide a saliva sample and to have the completed sample sent to a third party laboratory for testing. The laboratory sends the test results to IntellxxDNA and we use the test results to create the reports that you order regarding that patient.

We may also have information that you or your patient provide to us, such as information that identifies the patient (like your patient’s name and contact details) and payment information.

IntellxxDNA shares information that we receive about your patient with you as their clinician. For example, we include your patient’s relevant test results in the reports are shared with you through your IntellxxDNA clinician portal. We may also share your patient information with a limited number of third parties that have a need to access the information in order for us provide the services, such as our technology providers. In limited situations, we may also be legally required to make patient information available to regulatory authorities, law enforcement, courts and similar mandatory disclosures.

We protect the information that we have about your patients in accordance with applicable laws and regulations. We also comply with the terms of the Business Associate Agreement (“BAA”) that we entered into with you when you agreed to our clinician contract for IntellxxDNA’s services. The BAA is available to you through your IntellxxDNA portal. We also require any third parties that may have access to your patient information to enter into confidentiality agreements with us, in compliance with the BAA.

Can my patient get access to information that is provided by IntellxxDNA in clinician reports or access their lab test results?

IntellxxDNA supports the legal rights that patients have to access health information that is received and kept by companies like us that provide services to clinicians. The Business Associate Agreement that we entered into with you as a clinician also requires us to comply with applicable legal rights for patients to access data.

You have the ability (through your IntellxxDNA clinician portal) to provide your patients with access to a patient report (through their IntellxxDNA patient portal). The patient report includes the test results that have been used to create the reports ordered by you. Patients should request this report access through your office.

If your patient would like to receive access to other information (such as “raw” test results or billing or invoice information that we may have), please direct the patient to contact us at support@intellxxdna.com.

What happens to patient data over time?

Patient data is stored securely over time so that the IntellxxDNA services can continue to support your patient care over time and also to allow for you to request report updates and additional reports as scientific understanding evolves.

Under the contract that patients enter into with IntellxxDNA patients have the right to de-activate their IntellxxDNA account. If your patient chooses to de-activate their patient account with IntellxxDNA, it is important to know that this will mean that none of that patient’s data will be available to you or to them, at all. This means that, if you or another clinician wants to access IntellxxDNA services for that patient’s treatment, the patient will need to purchase IntellxxDNA services again and will need to submit a saliva sample for new testing. IntellxxDNA may retain information regarding deactivated accounts as necessary to meet its legal and compliance requirements.

If your patient wants information about account deactivation, please direct them to contact our support team at support@intellxxdna.com.

What happens if the company changes ownership?

Like other healthcare and technology companies, if IntellxxDNA is acquired or undergoes a major business change, data may be transferred to a new owner.

In that case, patient data would continue to be protected under applicable privacy and security laws, the patient’s contract with us, and their existing choices (such as whether they authorize research participation) would still apply.

Will IntellxxDNA use patient data for research?

No, unless your patient gives a specific written consent to have their data included in research or education.

When you as a clinician request IntellxxDNA services for a patient, you agree to a clinician services contract with us and your patient also agrees to a patient contract with us. These contracts limit how IntellxxDNA can use your patient’s data. They do not permit us to use your patient’s information for research or educational purposes.

However, we know that there may be situations where you may want your patient’s information to be used in research or education. If this happens, IntellxxDNA can only use your patient’s data for these purposes if the patient has signed a special written authorization form. This form requires IntellxxDNA to “de-identify” your patient’s data before it is used for research/education. This means that your patient’s name and other personal details are removed from the data that is shared with researchers so that the data provided for research/education is no longer directly tied to your patient as an individual. De-identifying your patient’s information allows researchers to study patterns without knowing who the data belongs to. The form also allows your patient to specify the specific use purposes that the patient agrees to. We can provide you with this special research authorization form.

If your patient has signed the special research authorization form and later decides that they no longer want their patient de-identified information to be included in future research, they can withdraw their patient authorization for future use by contacting us at support@intellxxdna.com.

Can I or my patient disguise how the patient’s identity appears in the IntellxxDNA system?

Yes. You can choose to use a name or identifier that is not your patient’s full or real name when registering the patient in our system. You or your practice administration office must do this at the time that they first request IntellxxDNA services for you.

If your patient has already been entered into our system under their real name, the patient may request that we use an alias going forward. However, a name change request may not delete the name originally used for your patient account in historical, archived or other data storage resources.