Section 1 – Patient Information

This section provides information about The DNA Company’s Testing, Supplement, and Education service (the “DNA Co. Offerings test”). The service is provided by The DNA Company, and undergoing this test, using any supplements offered, or following any education shared is your choice. We encourage you to ask any questions you may have about these offerings. By signing this form, you authorize The DNA Company to provide your personal information to licensed healthcare providers and their delegates (collective, “Licensed Healthcare Provider”) to evaluate the appropriateness of the DNA Co. Offerings for you and provide the requested services. The DNA Company and the Licensed Healthcare Providers may use your information in providing the DNA Co. Offerings test, evaluating the quality of the DNA Co. Offerings test, and to coordinate additional services that may be recommended, including using the contact information provided to contact you about such additional services.

 

Purpose of the Service.

The DNA Co. Offerings are recommended for use in adults and children alike. The DNA Co. Offerings are intended to be used in addition to and not to replace, medical or wellness services your healthcare provider recommends. Use of DNA Co. Offerings may not recommended in individuals who are pregnant, younger than 18 years old, or undergoing active medical treatment. The DNA Co. Offerings may not be appropriate for individuals who are experiencing or have a history with certain other health conditions, such as suicidal ideations or depression.

The purpose of the DNA Co. Offerings is to educate, empower, support, and provide supplements for individuals who seek to action their own health in an education fashion, using the most powerful tools available today .

DNA Co. Offerings uses additional self-reported data to construct a personalized blueprint across your DNA and Genomic profile that are clinically known to be impacted by your identified risk factors to calibrate the interpretation of any acute symptomatic or cell-free DNA signals. You acknowledge, understand, and agree that the quality of the DNA Co. Offerings is dependent on truthful and accurate self-reported responses.

Our tests are designed to assist in a multitude of wellness and educational ways. The Gut360 will help detail results in your Microbiome, the DNA 360 provides for a genetic expression and action plan, the early detection of cancer through the LiquidB product enhances the chances of identifying potential issues sooner rather than later. However, it’s important to understand that while we aim to maximize detection accuracy, and by signing this, you acknowledge, understand, and agree that no screening process can guarantee the identification of all cancers and some cancers may still be missed. You also acknowledge, understand, and agree that it’s a valuable tool in your health monitoring toolkit, but not an absolute safeguard.

 

Service Process.

The DNA Company Inc. (“The DNA Company”), the company that created the DNA Co. will service your blood sample to look for cancer signals. The DNA Company will report the results of the DNA Co. Offerings to the Licensed Healthcare Provider who will share the results with you. Depending on the service results and other clinical and risk factors, you will be referred back to your primary healthcare provider and together you and your primary healthcare provider may decide what additional follow-up services, using clinically established procedures, are needed to confirm if cancer is present based on the results of the DNA Co. Offerings test.

 

Limitations of the Service.

The DNA Co. KliquidB Offerings does not detect all cancers and should be used in addition to routine cancer screening services recommended by a healthcare provider. DNA Co. Offerings are intended to guide clinical support from your licensed health care professionals. Results should be interpreted by a healthcare provider in the context of medical history, and clinical signs and symptoms. You acknowledge, specifically to the LiquidB product and understand, and agree that a service result of “cancer signal not detected” does not rule out cancer. You also acknowledge, understand, and agree that a service result of “cancer signal detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., biopsy) to confirm cancer. If cancer is not confirmed with further diagnostic testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. You understand and acknowledge that false-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) service results do occur. By signing this form, you agree to proceed with the risk of a false-positive or false-negative result and release The DNA Company, the clinical laboratory, and the Licensed Healthcare Provider from any and all liability related to the same. The service is prescription (Rx) only. You understand, acknowledge, and agree that you may only obtain the DNA Co. Offerings pursuant to an order signed by the Licensed Healthcare Provider.

 

Laboratory Information.

The clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The DNA Co. Offerings was developed, and its performance characteristics were determined by the laboratory. The clinical laboratory is regulated under CLIA to perform high-complexity testing. All genomic tests are intended for clinical purposes. The DNA Co. Offerings has not been cleared or approved by the Food and Drug Administration. You understand and acknowledge that you are agreeing to a service that has not been approved by the Food and Drug Administration. You agree to proceed with any risks related to the DNA Co. Offering test and release The DNA Company, the clinical laboratory, and the Licensed Healthcare Providers from any claims that may result directly or indirectly from the DNA Co. Offering test, including any claims or damages related to Food and Drug Administration approvals.

 

Disclosure of Service Results.

Your DNA Co. Offerings results are confidential; these results, as well as your leftover blood sample and medical information, may be disclosed only to the following limited group of individuals and organizations unless you have provided us with written approval to share the information with additional parties:

• The Licensed Healthcare Provider to whom The DNA Company discloses
• Your healthcare providers (or their designated representative)

You may also request your DNA Co. Offerings results by contacting The DNA Company’s Customer Service.

 

Secondary Data Uses.

The individuals or entities listed above may generate, keep, use, and/or share your service result information that has been disclosed or information that readily identifies you in accordance with applicable federal law. In addition to your DNA Co. Offerings results, your leftover blood sample and medical information (including certain follow-up clinical information) that have been disclosed or information that readily identifies you may be shared within The DNA Company. You acknowledge, understand, and agree to the following:

These secondary uses may:

• Improve or evaluate the performance, safety, effectiveness, or quality of The DNA Company’s products;
• Help develop guidelines for health care providers to follow when other patients receive Cancer Signal results from the service;
• Inform you or your healthcare provider about treatments, products, and services from The DNA Company or other companies that are relevant to your service result;
• Inform you or your healthcare provider about clinical trials for which you may be eligible; and/or
• Be used for service validation, research, and/or other future purposes, unless prohibited by applicable law;
• Be used as de-identified data in aggregate form to investigate the overall cancer detection performance and mortality reduction of the DNA Co. Offerings and use these results in public communication.

 

Retention of Samples.

The clinical laboratory will retain all samples for a minimum of 2 years after issuance of the final test result in accordance with CLIA regulation and to the extent allowed by applicable law. The clinical laboratory may then choose to destroy the sample or retain the processed blood sample indefinitely and use the blood sample without information that readily identifies you for certain activities, including research purposes, to the extent allowed by applicable law. You are not entitled to compensation for the use of your blood sample or rights to any products or discoveries resulting from use of your blood sample. If you do not want your leftover blood sample to be retained or used in the manner described in this consent, you may request that your sample be destroyed by contacting the DNA Company’s Customer Service Department.

 

Ownership of Results.

By agreeing to the DNA Co. Offering service, you release your rights to biological samples collected and retained for servicing and your rights to any results generated from the servicing unless you specifically contact The DNA Company’s Customer Service Department to request that your sample be destroyed.

 

Use of Information for Research

The DNA Company may de-identify your test results, which means removing information that could directly identify you, specifically your name, date of birth, and contact information. These de-identified results may then be used for clinical research purposes, aimed at improving medical treatments, diagnostics, and patient care. Your participation in this research is entirely voluntary and you can withdraw your consent without affecting your medical care or legal rights by contacting The DNA Company’s Customer Service Department within 60 days after signing this consent.

 

Privacy and Data Security

Your privacy is important to The DNA Company. Details about The DNA Company’s policies governing patient privacy and health information, including patient rights regarding such information, can be found at www.thednacompany.com/policies/privacy-policy, or will be made available to you upon request by emailing The DNA Company’s Customer Service Department. The DNA Company complies with the applicable requirements of the US Health Insurance Portability and Accountability Act of 1996 (HIPAA). The DNA Company implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your protected information. You agree that The DNA Company is not liable for the unauthorized release of your information, unless such release was the result of gross negligence or willful misconduct on the part of The DNA Company. In the event of a data breach, we intend to comply with all applicable reporting requirements.

 

Patient Acknowledgement and Signature

By requesting the DNA Co. Offerings test, I confirm that I have read this patient information section and any other information provided to me by The DNA Company or the ordering healthcare provider, including the purpose, risks, benefits, and alternatives of this service. I have been provided the opportunity to ask all appropriate questions and am satisfied with the explanations. I understand that providing my signature below means that I have fully read and understand this consent form. I understand that this test is voluntary and I hereby agree to take part in this servicing. I understand that my leftover blood sample may be retained indefinitely by The DNA Company. I understand that I will be given a copy of this form to keep for my records.

The person signing this consent, whether the patient or a parent, guardian, or another person with legal responsibility for the patient, is of legal age and has the authority to provide consent to authorize this test. I understand that I may receive a copy of this consent upon request at any time.

 

Section 2 – DNA Co. Offerings Liquid Biopsy Test

This document has been prepared to inform you about the liquid biopsy test which The DNA Company provides its multi-cancer detection service. It is not intended as a substitute for pre-test counseling. Prior to completing this form, you are encouraged to ask any questions you may have regarding this voluntary test or alternative testing options.

 

General Information.

When cancer develops in the body, the genetic information (DNA) in the cells is altered, known as a mutation. Cancer cells often shed mutated DNA into the bloodstream as “cell-free DNA” (cfDNA). Therefore, cfDNA in the blood has been recognized as a potential marker of cancer. These cfDNA fragments can be detected in a blood sample that is analyzed using advanced gene sequencing techniques. This method is called “liquid biopsy”.

The DNA Company’s DNA Co. Offeringsis offered as a screening tool for potential cancer signal detection and may assist your healthcare team in making informed decisions about how to proceed with your medical care, including additional screening tests and medical management.

Potential results include low risk findings without further recommendations or high-risk findings that necessitate further diagnostic measures, which should be reviewed by your primary care doctor. The results of these tests should not substitute any standard screening guidelines.

 

Methodology.

The DNA Company’s DNA Co. Offering screening test uses a validated laboratory process to isolate cfDNA from a blood sample. The cfDNA is then analyzed using deep sequencing technology.

Once the cfDNA is sequenced, the machine learning model, DEEPGEN, compares the patient’s mutational profile against the mutational profiles of patient populations diagnosed with seven different cancers. The model then assesses the statistical similarity between the patient and groups of patients diagnosed with cancer. Your test results will include an evaluation of your cancer risk based on analyses using the DEEPGEN machine learning model. Your test results will also include a listing of any cancer-associated variants found in your sample. The Licensed Healthcare Provider will discuss the risks, findings, and potential implications with you.

This screening test is not designed to diagnose cancer, and it does not replace society-guided cancer screening recommendations. It is possible your primary care physician may recommend additional tests, including laboratory tests, imaging studies, biopsies, and others, to follow up after a positive result. Recommendations for follow-up testing should be provided by your primary care physician.

You understand and acknowledge that this test may generate false-positive or false-negative results for a variety of reasons. By signing this form, you agree to proceed with the risk of a false-positive or false-negative result and release The DNA Company, the clinical laboratory and the Licensed Healthcare Provider from any and all liability related to the same.

A false-positive result may occur in cases of:

• Benign tumors: Research indicates that mutations in the blood might be increased in patients with benign
• Inflammatory diseases: Research indicates that certain inflammatory diseases can cause the presence of mutations that have also been found in cancer.
• Other diseases: Liquid biopsy is a novel technology and extensive data on other diseases are not yet available. Mutations might be elevated by the presence of other diseases.
• Technical errors: Unexpected technical errors can occur, even though the robustness of this technology has been demonstrated through Clinical Laboratory Improvement Amendments (CLIA) certification, which is required for market approval.
• Other reasons not specified that may be discovered over

A false-negative result might occur if:

• The mutations of your tumor are not covered by the panel (DEEPGEN) and are thus
• There was not enough cfDNA in your blood sample to be detected by the DEEPGEN This is particularly likely in small or early-stage cancers with limited access to the blood system.
• Technical errors: Unexpected technical errors can occur, even though the robustness of this technology has been demonstrated through Clinical Laboratory Improvement Amendments (CLIA) certification, which is required for market approval.
• Other reasons not specified that may be discovered over

 

Risks & Limitations.

It is important to understand the general risks and limitations of liquid biopsy testing, including the following:

• Three tubes (10 ml each) of blood will be required to perform the liquid biopsy Adverse reactions to a blood draw are rare but may include dizziness, fainting, pain, bleeding, bruising, and infection.
• This test does not diagnose cancer. Not detecting any mutations does not rule out that you have cancer today, nor does it mean that you do not have a risk of developing cancer later.
• The test offered is only intended to identify mutations associated with some of the most common types of tumors. Tumors not associated with the somatic mutations and cancers analyzed by this test will not be identified.
• This test does not test for germline variants associated with hereditary cancer syndromes. The test is designed to detect only somatic mutations in cfDNA.
• This test may not provide results due to: (1) non-genetic factors; (2) individual genetic variation; (3) insufficient scientific information on the relationship between genetic information and health outcomes; (4) laboratory problems and/or other technical reasons; or (5) incomplete gene sequence information.
• Other risks of this test include the potential psychological impact of test results, genetic discrimination, and loss of confidentiality. Test results and information may be part of the patient’s permanent medical record and may be available to individuals and organizations with legal access to such records.
• Although we will take every precaution to protect your personal information, there is a risk that your privacy may be Storing the information in a secure computer database will limit that risk but does not eliminate it completely.
• This testing should not be used as a substitute for any standard of care cancer screening. Please adhere to your primary care physician’s recommendations with respect to the same.

Further Considerations.

Certain results of the liquid biopsy test may warrant further evaluation as determined by your primary care physician. The DNA Company is not responsible for the costs of any further evaluation which may consist of, but is not limited to, laboratory testing, imaging, and specialist referrals.

The amount of cfDNA emitted by the tumor may be below the detection capability of the test. If this happens, the results will be considered indeterminate, and a second specimen will be requested for analysis at no additional cost. After testing the second blood sample, a negative or positive result may be reported, as appropriate.

 

Patient Acknowledgement and Signature

I hereby consent to The DNA Company’s DNA Co. Offeringsfor cancer risk analysis. I understand that providing my signature below means that I have fully read and understand this consent form. I understand that this test is voluntary. I acknowledge that I have read the benefits, risks, alternatives, and limitations of this test, as described in this document, and I understand those as written. I have been provided the opportunity to ask all appropriate questions and am satisfied with the explanations. I understand that a copy of this consent form will be provided to me for my records.

The person signing this consent, whether the patient or a parent, guardian, or another person with legal responsibility for the patient, is of legal age and has the authority to provide consent to authorize this test. I understand that I may receive a copy of this consent upon request at any time.

 

Section 3 – Virtual Consultation and Follow-Up:

After your DNA Co. Offerings reports are generated, you may select to have a Licensed Healthcare Provider discuss your results over a video telehealth consultation, as scheduled by The DNA Company. In the event the video platform is unavailable, you may be given the option to schedule a phone visit with the Licensed Healthcare Provider or communicate with the Licensed Healthcare Provider via written communication. This telehealth consultation offers a valuable opportunity to ask questions and clarify concerns with a healthcare professional in a convenient manner. By signing this form you acknowledge and understand that your visit with the Licensed Healthcare Provider will be scheduled and provided via a telehealth platform, and you agree to proceed with the consultation using telehealth modalities. Please be aware, this consultation is supplementary and does not substitute for follow-up care from your primary healthcare provider, and by signing this form, you understand, acknowledge and agree that it is your responsibility to follow up with your primary care provider. Depending on your results and personal health history, further diagnostic evaluations may be advised by your primary care provider. You understand, acknowledge, and agree that the Licensed Healthcare Provider will not be responsible for providing you ongoing care after the telehealth consultation is complete.

 

Consent for Virtual Consultation Services:

I consent to engage in telehealth consultations as part of The DNA Company DNA Co. Offerings. I understand these consultations uphold the same standards of confidentiality and data protection as traditional in-person consultations. I recognize the benefits of telehealth consultations for their convenience and accessibility, and I commit to ensuring a secure and private setting on my end for these discussions. I understand that telehealth consultations may involve electronic communication of my personal health information to providers who may be located in other areas, including out of state. I understand that I have the right to inspect all information obtained and recorded in the course of a telehealth interaction and may receive copies of this information for a reasonable fee.