Summary  

This Informed Consent document summarizes the benefits, limitations, and risks of undergoing blood and clinical data analysis by 20/20 GeneSystems, Inc. (“20/20”) to assess the potential likelihood of having one or more types of cancer (presently marketed under the trademark “OneTest™”; referred to in this document as “the Test”). It also describes how your blood specimen and health information may be used after the test is performed. For us to process your blood specimen and provide you and your healthcare provider with your results, you must confirm by signing below or otherwise acknowledging that you have read, understand, and agree to this Informed Consent. 

About the Test 

The Test measures a panel of protein biomarkers that circulate in the blood and combines those measurements with certain clinical factors to assess the likelihood that an individual may have cancer. A machine learning algorithm generates a score by comparing the results from the individual being tested with those of thousands of others similarly tested. 
 

Potential Benefits of the Test 

If the test results show a higher than normal likelihood of cancer and are followed up by other diagnostic tests such as imaging, you might detect early-stage cancer that could be potentially cured with surgery. Furthermore, since published studies have demonstrated that the levels of some of the biomarkers in the Test often rise as certain cancers grow (e.g. ovarian, pancreatic, colon) your initial test may serve as a baseline to improve the predictive ability of future tests.   

Also, by participating (optionally) in our ongoing Research & Development (see below) your test results and sample could contribute to the early detection of cancer for others. 
   

Potential Limitations and Risks of the Test 

The Test is intended to identify abnormally high levels of certain biomarkers (tumor antigens) known to be associated with several cancer types but also some benign conditions.   Moreover, no currently available tests measures all known cancer biomarkers and the best detection biomarkers may yet be discovered and validated. 

Analysis of results is based on currently available information in clinical databases and the medical literature, as well as algorithms and machine learning informatics that may be subject to change. New information may replace or add to the information that was used to analyze your results. Based on this new information and/or modifications to our machine learning informatics and algorithms, you understand and agree that 20/20 may or may not, at its sole discretion, amend or modify your Test report, which may result in a change in your score or cancer likelihood assessment. 20/20 may attempt to notify you of any material amendments or modifications. You hereby irrevocably waive any and all claims against 20/20 for any amendment or modification of the Test Report, or failure to do the same, in accordance with 20/20’s standard operating procedures. 

As of mid-2022, the Test algorithms were developed primarily with data from individuals of East Asian origin. Although we have evidence that the biomarker levels do not appreciably vary between East Asian and American populations we cannot predict whether the algorithm scores, which are derived using clinical factors in addition to biomarker levels, might vary between these populations.   

You understand that 20/20 is neither qualified nor licensed to provide individual interpretations of test results nor to offer advice as to what follow-up procedures might benefit particular persons who obtain this Test. Nevertheless, we may from time to time provide general guidance on our website www.OneTestforCancer.com and may also introduce or make available to healthcare professionals expert opinions on protein biomarker tests from various medical or scientific experts. You understand, however, that accurate cancer detection, especially at early stages, is exceedingly difficult, complex, biologically variable, and imperfect and can often result in unnecessary follow-up (false positives) and missed cancers (false negatives). In addition, if you have certain benign or chronic conditions, provide incorrect or incomplete information on the Health Questionnaire, or have a tumor that does not produce antigens at levels that our assays or analyzers can reliably detect, these conditions will likely alter the accuracy of the results.

The Test is NOT a definitive test for cancer. The only definitive test for any cancer is an analysis of biopsied tissue by a qualified pathologist. It is not uncommon to have high biomarker levels and/or a high algorithm-derived Test score but not have any cancer. Some individuals might have inflammatory or other diseases which could result in a false-positive result as determined by the Test. 

Low Test scores result should not be used to rule out the presence of cancer. Because the Test does not have 100% sensitivity, you may receive a false negative result (a score or biomarker report) even if you do have cancer. 

No single, easy to administer the tool, including this Test, reliably detects all early-stage cancers. 20/20 expressly disclaims any liability for false positives or false negatives due to any of the aforementioned factors, without limitation, and you expressly waive any claims against 20/20 expect those which result from the proven gross negligence or willful misconduct on the part of 20/20. 

Other sources of error, while rare, include sample mix-up, poor sample quality or contamination, and laboratory errors. 20/20 implements several safeguards to avoid technical errors, but as with all medical tests, there is nevertheless always a very slight chance of incorrect or inaccurate results due to laboratory error.    

The known risks of the blood draw are discomfort as the needle is inserted, bleeding, and bruising. Infection from a blood draw is rare but may happen. If you are uncomfortable at the sight of blood you may feel light-headed or faint. Risks will be minimized by having the blood drawn by a trained medical professional. 

There is a risk of loss of confidentiality about your personal and medical information. 

About Our Laboratory 

20/20 operates a clinical testing laboratory that meets the certification requirements for high complexity testing as set forth under the Clinical Laboratory Improvement Amendments (CLIA) as administered by the U.S. Department of Health & Human Services and the Maryland Department of Health. 

Blood Sample & Health Information Collection, Transport, and Testing 

A physician or other qualified healthcare provider will review your information, and if they agree that the Test is appropriate for you, will order the Test on your behalf and receive the results and go over them with you. If you don’t have a physician or your physician does not wish to order the Test, we will work with you to identify an independent, qualified medical practitioner or telemedicine provider who can help you with the interpretation of the test results. 

You will also be asked to complete and submit an electronic (or paper) Health Questionnaire to provide information about your current health status, disease history, and family history. This information from thousands of individuals like you will help train our computer programs to account for (i) benign conditions that might also elevate biomarkers in the absence of cancer and (ii) other diseases or risk factors that might elevate the cancer likelihood independent of biomarker values. Complete and accurate information on the Health Questionnaire will help improve the Test over time for you and other consumers. The Health Questionnaire will be maintained by 20/20 in complete confidence according to our Privacy Policy. 

A blood sample of up to 20 ml. (two small test tubes) will be collected by a phlebotomist from a vein in your arm in the same manner as is often done when you get a routine check-up. The blood (serum) specimen will be transported to 20/20’s lab using recommended temperature control processes. Unused serum may be frozen (-80oC) and stored for future research and development, for example, of new or alternative biomarkers such as DNA or RNA, unless you direct us otherwise. (See “Use of Blood Specimens and Information for Future Research & Development”, below.)  

After we run your sample and generate a report, you hereby request and authorize that a test report be communicated to you and the ordering physician for review. Unless you request otherwise, the test report will be sent to you electronically.   

Medical Follow-up Based on Test Results 

Upon completion of the Test, you are requesting that your results be made available to you and your provider as specified in your order form. By agreeing to this Informed Consent, you also agree that your biomarker values, health questionnaire, and results can be shared with your ordering provider, and with any healthcare provider that you or your ordering provider designates. You also agree that 20/20 may communicate with you about your order, results, account details, and other Test logistics and procedures. 

Having one or more biomarkers above the cut-off or having an algorithm score suggesting a higher than average likelihood of having cancer does not necessarily mean that you actually have cancer since many benign conditions can also raise biomarker levels. These results are intended to prompt a timely engagement between you and your healthcare providers about possible follow-up testing. This may include repeat testing of one or more biomarkers over time, an imaging test, or referral to a medical specialist.    

On the other hand, even if all biomarkers are below their cut-offs or have an algorithm score suggesting only an average likelihood of cancer does not rule out the possibility of having cancer. In no event should you consider this Test to be a substitute or replacement for routine cancer screening tests recommended in the guidelines of leading medical organizations including mammograms, colonoscopies, and PAP smears.    

By signing this Informed Consent, you understand and agree that your results must be reviewed with qualified medical personnel of your choosing and that you should not make medical decisions without consulting one or more healthcare providers. 20/20 does not provide medical services, diagnosis, treatment planning, or individualized advice. 

Follow-up information about whether or not you have developed cancer will be collected. This information will be very important to help us demonstrate the accuracy of the test and to make improvements. For those deemed at low risk, follow-up will be collected about one year after reporting the test results. For those deemed at high risk, follow-up may be sooner, (e.g. 1-2 months after reporting the test results. In all cases, the decision to receive follow-up testing (e.g. CT scans, ultrasound, etc.) or not will be yours alone in consultation with the medical professionals that you alone choose.  

Privacy and Data Security 

Your privacy and preserving the confidentiality of your health information is a very high priority for 20/20. Details about 20/20’s policies governing patient privacy and health information, including patient rights regarding such information, can be found at www.OneTestforCancer.com/privacy, or will be made available to you upon request by emailing support@OneTestforCancer.com. 20/20 complies with the applicable requirements of the Health Insurance Portability and Accountability Act of 1996 (as amended) regarding Personally Identifiable Information (PII). 20/20 implements certain physical, managerial, and technical safeguards that are designed to protect the integrity and security of your PII. 20/20 cannot, however, guarantee the security of any information you transmit to 20/20 or store on the 20/20 website, and you do so at your own risk. You agree that 20/20 is not liable for the unauthorized release of your PII, results, or medical information unless such release was the result of gross negligence or willful misconduct on the part of 20/20. In the event of a data breach, we intend to comply with all federal and state reporting requirements. By agreeing to this Informed Consent you agree that the laws and regulations of the US regarding data privacy and collection, use, processing, and storage of patient information shall govern 20/20’s performance of the Test and handling of your sample and information, even if they may differ from those of your country of residence. You further agree that by providing your sample, you are not violating any export ban or other legal restrictions in your country. 

People outside of 20/20 GeneSystems may need to review your results. Examples include government agencies and other safety monitors (such as the Food and Drug Administration, the Institutional Review Boards (IRBs), Office of Human Research Protection). These entities and/or individuals have an obligation to protect your health information.   

We work to make sure that everyone who needs to see your information keeps it confidential – but we cannot offer a 100% guarantee that your information will not be redisclosed.   

Information that does not include personally identifiable information from this study may be published in scientific journals or presented at scientific meetings. We plan to combine the results from thousands of customers like to assess the performance of the Test. The information may be given to the FDA or other government health agencies as part of applications. 

Your Blood Specimens and Information for Ongoing Research & Development (Optional)  

Unless you decline with written notice to research@2020gene.com, by signing this Informed Consent you acknowledge and agree that 20/20 and its research collaborators may de-identify (i.e. remove your name, address, and other information that identifies you) any unused portions of your blood or serum sample, health information, medical history (e.g., age, tobacco usage, family history of cancer, disease history, etc.), the Test analysis, results, and reports, and clinical outcomes over time,  (collectively “Clinical Information”) and aggregate this with de-identified Clinical Information from other consumers. This Clinical Information may be used by 20/20, or a third party under contract with 20/20 that agrees to be bound by the Privacy Policy herein, without limitation, for any of the following purposes (collectively “R&D”): 

• Future research and development including, without limitation, machine learning, and algorithm improvements; 

• Validation studies and generation of real-world evidence (RWE) of the Test’s accuracy and effectiveness through a prospective collection of clinical outcome data after the test results are first reported; 
• Data generation for regulatory compliance or new submissions or internal quality control 
• Integration of Clinical Information and outcomes (i.e. whether cancer is diagnosed after the test) from thousands of individuals for any of the aforementioned purposes.   
• Comparing possible Test variability between various ethnic and geographic communities (e.g. American, East Asian, etc.) and training our algorithms to account for any such variability discovered 
• Evaluating both the health and economic benefits vs. possible harms of the Test 

• Improve the Test’s ability to correctly pinpoint the specific organs in which cancer may be found while avoiding harm associated with false positives. 
• Studies to be published in peer-reviewed medical or scientific journals, using such de-identified information, either on its own or in collaboration with academic or commercial third parties. 

You understand that the Test algorithm has been developed based on known cancer outcomes within about one year after the biomarkers were measured for thousands of individuals and that 20/20 intends to continue to collect this real-world outcome data for ongoing algorithm development and improvement. To assist in this regard, you, therefore, agree to alert us if you are diagnosed with cancer within about one year after taking a Test and to permit your doctors to provide us with information verifying this diagnosis. If the contact information that you have provided changes, or the names of your medical professionals change, you agree to notify us of the same in a timely manner by contacting Research@2020gene.com.    

• You will likely be contacted at least 12-months after the performance of the Test to determine if a positive diagnosis of cancer has been received. If your Test results indicate a medium or high risk for developing cancer, follow-up data information collection may begin sooner, 2-3 months after reporting the test results.  

• If you choose to have follow-up diagnostic testing for cancer for any reason and at any time during the 12-month period subsequent to the performance of the Test, you will be asked to provide the investigative team with information about the results of any cancer diagnostic testing that you undergo. 
• If you have a medium or high-risk result on the Test, 20/20’s investigative team or CLIA lab Medical director will contact you or your doctor to collect information about your health status and the results of follow up testing that you obtained by any of the following means: 

• Phone 
• E-mail 
• Study web-based portal 
• As a participant of this ongoing study, you are agreeing to alert the investigative team if you are diagnosed with cancer at any future date, for at least one year after you received your Test results. In all cases, the investigative team will likely contact you at the one-year mark to verify whether or not a cancer diagnosis has or has not been received.  

You also agree unless you provide us with written notice to the contrary, that your Clinical Information and the results from any R&D may be shared with third-party collaborators.   Such third parties may include government, academic, or commercial third parties. 20/20 may engage in research with such third parties to develop new tests and inventions or to validate and improve existing technologies or processes. You acknowledge and understand that 20/20 may receive financial compensation to conduct such research, which may include providing your de-identified data to such third parties. 

• You can opt out of R&D by notifying us at Research@2020gene.com. However, if you consent and later opt-out, 20/20 cannot exclude any Clinical Information from any R&D that was performed before you opted out.   
• You have the right to make inquiries about the status of any of our R&D that utilizes your Clinical Information by contacting Research@2020gene.com to the extent that responding to your inquiries does not require disclosing company confidential information, trade secrets, competitive intelligence, or other proprietary information or know-how. 
• If any new tests, technologies, processes, or inventions are made as a result of the research activities described above (whether made by 20/20 or by a third party), you agree that you will not receive any compensation, nor will you have any right, title, and/or interest in or to such new or improved tests, technologies, processes, or inventions. 
• 20/20 may contact you to solicit feedback (including through optional surveys, interviews, or testimonials), and describe new tests and services developed by 20/20 and its collaborators that may be of interest to you. You can opt out of this communication at any time. 
• 20/20 may access information about you contained in state or federal Cancer Registries to enable it to learn of your clinical outcomes after receiving the tests. 

Payments for and Commercial Uses of Clinical Information  

• As complete consideration for your participation in this research & development, the Test has been provided to you at a discount from its standard list price.  20/20 has the right to use any and all unused serum specimens, information from the Health Questionnaire, and algorithm analysis and calculations (collectively “Clinical Information”) for commercial purposes including, without limitation, product and algorithm development and improvements and intellectual property development and commercialization, without any additional payments or compensation to you. 20/20 also has the right to license, market or sell anonymized Clinical Information to any third party that agrees to comply with the Confidentiality and Privacy provisions herein without additional permissions from or compensation to you.  
• 20/20 is paying the costs of this research & development, including compensation to the research team and product developers. Your physician or healthcare provider may also be compensated by us for the following: (i) receiving initial and ongoing training by us and outside medical experts on the clinical use of the Test, (ii) explaining the Test to you and the nature of this Consent, (iii) reviewing the Test results with you, (iv) following up with you and perhaps other medical specialists to ascertain health outcomes (at most 12 months) after you have taken the test, and (v) conveying this data back to us in a timely manner. 

Consent 

I confirm that I have read (or have had read to me), all of the information in this Informed Consent document, and I understand what it says. I have had the opportunity to ask any questions I may have about the 20/20 Test and related issues, and any questions so posed have been answered to my satisfaction. I freely and voluntarily consent to undergo this testing, and I specifically acknowledge and consent to at least the following: 

• I am the individual providing the blood sample and I am at least 18 years of age, or I am the parent or legal guardian of a minor who is providing the sample for testing. 
• I understand that this Test is not intended to diagnose whether I have or will get cancer or any other disease. It is intended to tell me the levels of certain tumor-associated biomarkers and the likelihood of having cancer at the time the Test is taken relative to others previously tested for those biomarkers.   

• I should not make any medical decisions based on these results without speaking to qualified healthcare providers first. 
• The procedures involved, the purpose of storing my serum samples, and the strengths and limitations of the Test have all been made clear to me.  
• My de-identified blood sample and health information, and results (unless I have requested otherwise), may be added to databases used for regulatory compliance; internal quality control; laboratory validation studies; research and development; and educational purposes.  
• My sample and all my related personal information will be transferred to 20/20’s laboratory in the United States for analysis, use, processing, and storage, and will be subject to the laws, rules, and regulations of the United States. 
• If a minor will be tested, I further acknowledge and understand that while report information may be similar for adults and minors, the Test was neither designed nor intended for use with minors, and the consequences of testing minors are relatively new and less understood. 

• I also agree to the 20/20 Terms of Service and Privacy Policy, which are available at www.2020gene.com, www.OneTestforCancer.com, or upon request. 
•  I voluntarily agree that my unused blood specimen and health information can be stored and retained indefinitely by 20/20 GeneSystems for future research and development of OneTest™ or any related or ancillary products to aid in the early detection of cancer. 
•  As part of ongoing research and development to validate and improve the Test, I consent to allow my related personal health information to be shared with 20/20 GeneSystems, Inc., including the results of follow-up diagnostic imaging test and/or interventional procedures leading to a diagnosis of cancer performed subsequent to the Test. I agree to help the company obtain this follow-up information from me or my healthcare providers in a timely manner.  
•  I understand that the results of the aforementioned research may be patentable or have commercial value; I will have no legal or financial interest in any commercial development resulting from the research.