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.
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)
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 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.
Payments for and Commercial Uses of Clinical Information
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: