Terms and Conditions of Testing Services
Last Modified: March, 2022
20/20 GeneSystems, Inc., (“20/20”) a Delaware Corporation, is providing its OneTest™ blood test and algorithm, only to those who agree to the following terms and conditions (hereinafter “Terms of Service”).
By accessing or using this service, you expressly agree to be bound and abide by these Terms of Service. Please read them carefully.
- Requirements for Use of the Services
By using the Services, you represent and warrant to us that you are (i) of legal age to form a binding contract with 20/20, (ii) agree to these Terms of Service, and (iii) are not barred under any applicable laws from doing so or from receiving Services in the jurisdiction where you reside or where you use them. You must be a US resident who is 18 years or older to submit a blood sample, although the product is not currently recommended for individuals under age 40 due to the lower prevalence of cancer below that age.
- Additional Terms
Your use of the Services is also subject to any additional applicable terms, policies, or rules that we may post or provide a link to on our website www.OneTestforCancer.com. These additional terms include 20/20’s Privacy Policy and Informed Consent for Research & Development (if you choose to contribute to our database to help our machine learning algorithm improve). All such additional terms, policies and rules are considered part of these Terms of Service and are incorporated by reference.
- Description of Services
The Services currently include (i) analysis of the levels of certain biomarkers in the blood sample you provide, and (ii) for those who agree to our Informed Consent for Research & Development information from to a machine learning algorithm that predicts the likelihood of certain cancers based on your biomarker analysis and other clinical factors. These Services are presently available under the trademark “OneTest™” although we may offer the Services under one or more different trademarks or brand names in the future. Thus, any use of the term OneTest™ in these Terms of Service also refers to the same or related products that may be marketed under a different trademark or brand name.
- Changes to these Terms of Service and the Services
At our sole discretion, we may revise and update these Terms of Service and post the updated Terms of Service on our website www.OneTestforCancer.com. All changes are effective immediately upon posting to our website and will apply to all access to and use of the Services from that point onward. Your continued use of the Services after we post revised Terms of Service means that you acknowledge and agree to the revised Terms of Service.
We reserve the right to withdraw or amend the Services or any portion thereof in our sole discretion at any time without notice. We will not be liable if for any reason the Services or any portion are unavailable at any time or for any period.
- Promotional Spokespeople and Salespeople
From time to time, 20/20 may engage spokespersons, influencers, bloggers or other individuals or entities that have been compensated or incentivized to speak on behalf of 20/20. When you receive information from such a third-party source, such as a television or radio show host or actor, or a social media account, please note that such individuals or organizations may have been compensated by 20/20 for their statements or representations. Statements made on behalf of our product, if not authorized or approved by 20/20, may not be attributable to 20/20 and should not necessarily be relied upon in your decision to purchase our product.
- Ordering our Test
To access OneTest™, you must register for a portal account and complete (a) a Test Request Form (a/k/a Requisition Form) which must be countersigned by a physician or other qualified healthcare practitioner, (b) a Health Questionnaire, and (c) this Terms of Services Agreement.
We cannot perform the Services without collecting information from you but we will only collect information that will assist us in providing the Services that you have requested. For the Services to be provided as intended, you must provide accurate and correct information. Failure to provide the required information or to execute required documents may result in your sample(s) not being tested. By registering for the Services, you represent and warrant that the information you provide is accurate, current, and complete. You also agree that all information you provide to us, no matter how you do so, is governed by our Privacy Policy. You consent to us using your information in ways that are consistent with that policy.
You are required to create a 20/20 Online Account, choose a password, and treat your password as confidential. You agree not to let someone else access the Services using your username, password, or other information. You agree to let us know immediately of any unauthorized account access or any other breach of security. You also agree to ensure that you exit from your account at the end of each session. When accessing your account from a public or shared computer, you should use particular caution so that others are not able to view or record your password or your other information. 20/20 cannot and will not be liable for any loss or damage that results from your failure to comply with these obligations. You authorize 20/20 to authenticate your identity when accessing the Services. This may include asking you for your date of birth and other information that will allow 20/20 to reasonably verify your identity.
If we believe that you have violated these Terms of Service, we have the right at any time to disable or terminate your access to your account and/or the Services.
- Processing the Test
A venipuncture blood sample is required and must be shipped to our laboratory no more than 30 days after you complete the Health Questionnaire. Doing so will help to assure the quality and accuracy of your cancer likelihood score.
Your venipuncture blood sample must be returned in the specimen collection kit (or equivalent) according to the requirements in our instructions. Failure to ship your specimen in the manner described in the shipping instructions may result in a rejection of your specimen. provided to your healthcare practitioner.
By submitting your blood sample to our laboratory you agree to the following:
- You are submitting your own blood sample or a sample for someone for whom you are legally authorized to act.
- You are 18 years of age or older, or you are submitting a sample for a person who is 18 years of age or older for whom you are legally authorized to act.
- The blood sample was collected from a vein.
- You allow 20/20 to perform analysis on the blood sample you submit.
20/20 does not submit or process insurance claim paperwork or claims for the Services. OneTest™ is not covered under any coverage policy by insurance plans at this time. We do not expect the Services to be paid for by any health insurance policy and cannot guarantee that the fees charged for any Services will be reimbursed by any insurance provider.
- Interpreting Test Results
You understand that the health-related interpretations provided by OneTest™ are for informational purposes only and are not intended to definitively diagnose or treat any diseases or conditions. You should consult a physician or other qualified health professional before acting on any interpretation.
You further understand that neither 20/20 nor its employees or consultants can offer individualized medical advice to you beyond what is provided in our Test Report. You acknowledge that 20/20 does not warrant the accuracy, completeness, timeliness, or usefulness of the content, quality, interpretations, or recommendations of our Test Report or any other information provided through the Services.
- Participation in ongoing research and development
OneTest™ includes algorithms that were developed using health outcomes data (i.e., whether or not there was a diagnosis of cancer) collected approximately one year after the biomarker level assessment from tens of thousands of individuals that received this blood test. We seek to continuously improve our algorithms by collecting health outcomes data in a like manner from consumers like you.
As a condition of receiving certain discounts that we may offer from time to time, we are asking you to participate in this ongoing research and development and, to alert us to any confirmed diagnosis of cancer after taking OneTest™. Participation in this research and development is optional and voluntary. If you would like to participate, we ask you to provide your informed Research and Development Consent consistent with our Privacy Policy. We will only use your health outcomes information for research and development purposes with approval from an institutional review board (IRB) and with your consent.
- Communications
Consistent with our Privacy Policy you agree to receive communications from us in connection with your test and if you agree to participate in the research study, follow-up regarding your health outcomes, which may include emails, texts, or telephone calls. mobile push notices, or messages on our website.
You may wish to retain copies of these communications for your records. You agree that all digital agreements, notices, disclosures, and other communications that we provide to you meet any legal requirement that such communications be in writing.
- Intellectual Property Rights
OneTest™ (including but not limited to all information, software, code, algorithms, database, proprietary techniques, and patentable subject matter) are owned by 20/20 and its licensors and are protected by the United States and international copyright, trademark, patent, trade secret and other intellectual property or proprietary rights laws. To the extent that your data, in combination with data from many other individuals similarly tested, contributes to new intellectual property, ownership thereof shall remain with 20/20 and may be sold or licensed to third parties, as long as your personal identity is maintained anonymous, without remuneration to you.
- Geographic Restrictions
20/20 is a United States company that provides Services to persons over the age of 18 in the United States. We make no claims that the Services or any of its content are accessible or appropriate outside of the United States. Access to the Services may not be legal by certain persons or in certain countries. If you access the Services from outside the United States, you do so on your own initiative. If you do so, you will be responsible for compliance with local laws.
- Notice of Technical Limitations of OneTest™
Cancer can arise from minor genetic changes to otherwise normal cells in the body. As a result accurate detection of cancer, especially in its early stages, and reliably distinguishing cancer from non-cancer, poses substantial technical challenges. Thus, every test for cancer, including OneTest™, has important technical limitations that you should carefully consider before ordering this test and interpreting the results. These limitations include the following:
- OneTest™ is based on our current knowledge of many diverse technical disciplines including, without limitation, cancer genetics and biology, pathology, immunology, epidemiology, biostatistics, bioinformatics, computational biology, and artificial intelligence. This knowledge changes almost daily as more is learned through research and development. Thus an OneTest™ report based on the current state of knowledge may be interpreted differently in the future.
- OneTest™ is NOT a definitive test for cancer. The only definitive test for any cancer is an analysis of biopsied tissue by a qualified pathologist.
- OneTest™ is intended as an initial screening to indicate the potential need for further follow-up testing to confirm the presence of cancer. It is possible for an individual to have a high probability of cancer according to the OneTest™ but not have cancer. A low OneTest™ score result should not be used to rule out the presence of cancer.
- OneTest™’s algorithms were developed based on scientific studies of a specific population (East Asia). Thus, the interpretations you receive may be based on a population that differs from your ethnicity or genetic background. The algorithms derived from data from an East Asian population may not exactly translate to an American population.
- A high score (false positive) for an individual tumor marker may result from benign conditions which are not cancer.
- False-negative results may occur when a person receives a low score but has cancer. In addition, false-positive results may occur when a person receives a high score but does not have cancer.
- Every tumor is different. Every person has variations that are either unique to them or are not well described in medical and scientific literature.
- OneTest™ reveals the probability, likelihood, or risk of cancer. Most of those deemed to have a higher likelihood of cancer than the average person will not be found to have cancer.
- Repeat testing of individuals who have biomarker results at a slightly high or ambiguous level will usually be advised
20/20 takes its laboratory quality very seriously. Our laboratory meets quality control standards set by the Clinical Laboratory Improvement Amendments (CLIA). Despite our focus on quality, problems with our sample process may occur from time to time. These problems may result from sample misidentification, a contaminated sample, or insufficient serum (blood). We continuously perform quality control on our processes and procedures. Even so, errors may result during data generation in the lab and in the processing of the data on servers.
Tumor marker information that you choose to share with your health professional may become part of your medical record. That means it could be accessible to other health professionals and possibly health insurance providers in the future. Please see our Privacy Policy for further information about how we handle your information and your options for disclosure of such information.
OneTest™ should supplement, but never replace, routine cancer screening tests recommended by your healthcare professional and/or leading national medical organizations such as the American Cancer Society and various medical specialty organizations that publish practice guidelines. These screening tests that you should continue to receive include, without limitation, mammograms, colonoscopies, and PAP smears. (The PSA test that is part of OneTest™ is identical to those available from national lab chains).
Our Services do not incorporate a complete view of your health history. Before you act on any health information provided through OneTest™, please first consult with a healthcare professional. In addition, not all results from OneTest™ can or should be acted upon. If you have questions or concerns about your health, you should speak with a health professional.
OneTest™ is a Laboratory Developed Test (LDT) that is not currently regulated by the U.S. Food & Drug Administration (FDA). OneTest™ is subject to regulation by the Center for Medicare & Medicaid Services (CMS) and the Maryland Department of Health under the Clinical Laboratory Improvement Amendments (CLIA). In general, CLIA approval is directed at the technical performance and analytical validity of the test (i.e. whether the test delivers consistent results) rather than the impact of the test on disease outcomes.
The laboratory equipment and kits used to analyze the biomarkers in OneTest™ are cleared by the FDA for certain uses. Except for the PSA test, which is approved by the FDA for use in screening for prostate cancer, most of the other biomarker test kits used in the OneTest™ are cleared by the FDA generally for assessments of those suspected of having cancer or detecting recurrence of cancer among those previously diagnosed.
- Disclaimer of Warranties
20/20 makes its best efforts to collect accurate data, build accurate and useful algorithms, perform accurate blood testing, and offer analysis and reports of high quality. HOWEVER, WE DO NOT WARRANT THE ACCURACY OR USEFULNESS OF OUR PRODUCTS OR TECHNOLOGIES, NOR DO WE ENDORSE, WARRANT OR GUARANTEE THE ACCURACY OR USEFULNESS OF ANY OF THE TECHNICAL INFORMATION MADE AVAILABLE BY US IN CONNECTION WITH THIS PRODUCT (INCLUDING, WITHOUT LIMITATION, THE TEST REPORT).
YOUR USE OF THE SERVICES, ITS CONTENT, AND ANY FEATURES OR ITEMS OBTAINED THROUGH THE SERVICES, INCLUDING OneTest™, IS AT YOUR OWN RISK. THE SERVICES, THEIR CONTENT, AND ANY FEATURES OR ITEMS OBTAINED THROUGH THE SERVICES ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS, WITHOUT ANY WARRANTIES OF ANY KIND, EITHER EXPRESS, IMPLIED, OR STATUTORY. NEITHER 20/20 NOR ANYONE ASSOCIATED WITH 20/20 MAKES ANY WARRANTY OR REPRESENTATION WITH RESPECT TO THE COMPLETENESS, SECURITY, RELIABILITY, QUALITY, ACCURACY, OR AVAILABILITY OF THE PRODUCTS OR SERVICES. WITHOUT LIMITING THE FOREGOING, NEITHER 20/20 NOR ANYONE ASSOCIATED WITH 20/20 REPRESENTS OR WARRANTS (i) THAT THE SERVICES, THEIR CONTENT, OR ANY FEATURES OR ITEMS OBTAINED THROUGH THE SERVICES WILL BE ACCURATE, RELIABLE, ERROR-FREE, OR UNINTERRUPTED, (ii) THAT DEFECTS WILL BE CORRECTED, (iii) THAT OUR SITE OR THE SERVER THAT MAKES IT AVAILABLE ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS OR (iv) THAT THE SERVICES OR ANY FEATURES OR ITEMS OBTAINED THROUGH THE SERVICES WILL OTHERWISE MEET YOUR NEEDS OR EXPECTATIONS OR THOSE OF YOUR HEALTHCARE PROVIDER.
20/20 AND ALL PARTIES ASSOCIATED WITH 20/20 HEREBY DISCLAIM ALL WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT, AND FITNESS FOR PARTICULAR PURPOSE.
You understand that we cannot and do not guarantee or warrant that content available for downloading from our website or any links provided on our website will be free of viruses or other destructive code. You are responsible for implementing sufficient anti-virus protection to meet your needs. You are also responsible for maintaining a means external to our website for any reconstruction of any lost data. WE WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGE CAUSED BY A DISTRIBUTED DENIAL-OF-SERVICE ATTACK, VIRUSES, OR OTHER TECHNOLOGICALLY HARMFUL MATERIAL THAT MAY INFECT YOUR COMPUTER EQUIPMENT, COMPUTER PROGRAMS, DATA, OR OTHER PROPRIETARY MATERIAL DUE TO YOUR USE OF OUR WEBSITE OR ITEMS OBTAINED THROUGH THE WEBSITE OR TO YOUR DOWNLOADING OF ANY MATERIAL POSTED ON IT, OR ON ANY SITE LINKED TO IT.
THE FOREGOING DOES NOT AFFECT ANY WARRANTIES WHICH CAN NOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
- Limitation of Liability
IN NO EVENT WILL 20/20, 20/20 AFFILIATES OR THEIR LICENSORS, SERVICE PROVIDERS, EMPLOYEES, AGENTS, OFFICERS, OR DIRECTORS BE LIABLE FOR DAMAGES OF ANY KIND, UNDER ANY LEGAL THEORY, ARISING OUT OF OR IN CONNECTION WITH YOUR USE, OR INABILITY TO USE, THE SERVICES, OR ANY CONTENT ON OUR WEBSITE OR SUCH OTHER WEBSITES, INCLUDING ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, INCLUDING BUT NOT LIMITED TO, PERSONAL INJURY, PAIN AND SUFFERING, EMOTIONAL DISTRESS, LOSS OF REVENUE, LOSS OF PROFITS, LOSS OF BUSINESS OR ANTICIPATED SAVINGS, LOSS OF USE, LOSS OF GOODWILL, LOSS OF DATA, AND WHETHER CAUSED BY TORT (INCLUDING NEGLIGENCE), BREACH OF CONTRACT OR OTHERWISE, EVEN IF FORESEEABLE.
THE FOREGOING DOES NOT AFFECT ANY LIABILITY WHICH CAN NOT BE EXCLUDED OR LIMITED UNDER APPLICABLE LAW.
- Indemnification
You agree to defend, indemnify, and hold harmless 20/20, its affiliates and licensors and their respective officers, directors, employees, contractors, agents, licensors, and suppliers from and against any claims, liabilities, damages, judgments, awards, losses, costs, expenses or fees (including reasonable attorneys’ fees) resulting from your violation of these Terms of Service or your use of the Services, including, without limitation, any use of the content, services, and products of the Services other than as expressly authorized in these Terms of Service or your use of any information obtained from the Site.
- Dispute Resolution
If a dispute arises between you and 20/20, you agree to first contact 20/20’s Customer Support technicalsupport@onetestforcancer.com to seek a resolution. If our Customer Support is not able to resolve the issue, then except for disputes relating to the infringement or other misuse of intellectual property rights:
- Such dispute will be resolved through binding arbitration rather than in court.
- This arbitration will be administered by the American Arbitration Association (“AAA”).
- Such arbitration will follow the rules of the AAA (“AAA Rules”), as modified by these Terms of Service.
- The arbitration will be conducted in the English language.
- Any arbitration hearing will be held in Montgomery County, Maryland.
If the arbitrator finds that either the substance of your claim or the relief sought is frivolous or brought for an improper purpose (as set forth in the Federal Rules of Civil Procedure Rule 11), then the AAA Rules will apply regarding payment of arbitration costs. The AAA Rules and fees are available online at www.adr.org or can be obtained by calling the AAA at 1-800-778-7879.
You and 20/20 both agree that either party may bring suit in court to enjoin infringement or another misuse of intellectual property rights.
You and 20/20 agree that each may bring claims against the other only in your or its individual capacity, and not as a plaintiff or class member in any purported class, consolidated or representative proceeding. Further, unless both you and 20/20 agree otherwise, the arbitrator may not consolidate more than one person’s claims, and may not otherwise preside over any form of a representative or class proceeding.
If this Section is found to be unenforceable, then this Section will be null and void. In such case, you and 20/20 agree that the exclusive jurisdiction and venue described in the Section will govern any action arising out of or related to these Terms of Service.
- Waiver and Severability
No waiver of these Terms of Service by 20/20 shall be deemed a further or continuing waiver of such term or condition or any other term or condition. Any failure of 20/20 to assert a right or provision under these Terms of Service shall not constitute a waiver of such right or provision.
If any provision of these Terms of Service is held by a court of competent jurisdiction to be invalid, illegal, or unenforceable for any reason, such provision shall be eliminated or limited to the minimum extent such that the remaining provisions of these Terms of Service will continue in full force and effect.
- Entire Agreement
These Terms of Service, our Privacy Policy, and Research & Development Consent (if you choose to participate in the optional OneTest™ algorithm development) constitute the sole and entire agreement between you and 20/20 with respect to the Services and supersede all prior and contemporaneous understandings, agreements, representations and warranties, both written and oral, with respect to the Services.
- Miscellaneous
These Terms of Service and any dispute or claim arising out of, or related to, them, their subject matter, or their formation (in each case, including non-contractual disputes or claims) will be governed by and construed in accordance with Maryland law, without regard to its conflicts of laws principles and excluding the applicability of United Nations Convention for the International Sale of Goods. To the extent that any lawsuit or court proceeding is permitted hereunder, you and 20/20 agree to exclusively litigate such disputes in the state courts located in Montgomery County and the federal courts located in Maryland, and both parties consent to venue and personal jurisdiction in Maryland. You may not assign any of your rights in these Terms of Service, and any such attempt is void. 20/20 may assign its rights to any of its affiliates or subsidiaries, or to any successor in the interest of any business associated with the Services. 20/20 and you are not legal partners or agents of one another.
