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Testing Consent Form (Except NV, NY)

Bioscope.ai Testing Consent Form

This Testing Consent Form (“Consent Form”) will provide you with information regarding the laboratory test(s) provided by Bioscope.ai, Inc. (“Bioscope”) that your health care provider has ordered for you. These tests may include whole genome sequencing and microbiome analysis. You should discuss the test(s) with your health care provider. To assist you in understanding the reason for this testing, this form provides information about the testing process and potential results.

Purpose and Implications of Testing
The purpose of laboratory testing is to analyze biological samples to provide information that can assist your health care provider in making diagnoses, determining treatment options, or guiding lifestyle changes. The specific purpose of your test(s) will depend on the type of test ordered by your health care provider and may include the following:

  • Genetic Testing. Whole genome sequencing (WGS) is a genetic test that reads nearly all of your DNA which is the genetic instruction set found in your cells. Your DNA contains approximately 20,000 to 25,000 genes and roughly 3 billion base pairs. WGS is performed to determine if a genetic disease may be present, if there is an increased risk for a genetic disease, or if there is an increased risk of passing a genetic disease onto a child. It can also identify genetic characteristics and traits that provide information about how you may respond to medications or the effectiveness of a particular drug (pharmacogenomics), which can assist your health care provider in determining which medications to prescribe. However, genetic testing cannot always determine when or what symptoms of a condition may show, which symptoms will occur first, how severe the condition will be, or how the condition will progress over time.

  • Microbiome Analysis. Microbiome testing analyzes the DNA of microorganisms such as bacteria, fungi, and viruses present in your stool sample to provide insights into microbial composition and function. These tests can provide information about your current health status and biological function that may assist your health care provider in making clinical decisions. During microbiome sequencing, some of your human DNA may also be captured incidentally. This human DNA is not individually analyzed, interpreted or reported as part of the microbiome test. The only use of incidentally captured human DNA in microbiome testing is to calculate an aggregate quantity (i.e., the total proportion of human versus microbial DNA in the sample). No genetic variants, disease risks, or other individualized genomic information will be derived from human DNA obtained through microbiome testing.

In rare cases, persons who have undergone genetic testing and have been diagnosed with a genetic condition have experienced problems with health insurance coverage, employment, and social discrimination if the genetic test results or genetic data become known to others. Federal law (the Genetic Information Nondiscrimination Act, or GINA) prohibits discrimination based on genetic information in health insurance and employment. However, GINA does not cover life insurance, disability insurance, or long-term care insurance. State laws may provide additional protections. For more information about how you are protected against discrimination based on your genetic information, you can visit https://www.genome.gov/about-genomics/policy-issues/Genetic-Discrimination.

Description of Bioscope’s Testing Services
Bioscope facilitates various laboratory tests ordered by your health care provider. These tests are performed by one or more qualified laboratories or testing service providers contracted by Bioscope (each, a “Testing Laboratory”). Testing Laboratories may hold different certifications or accreditations depending on the type of test performed; details regarding each Testing Laboratory’s certifications are available on our Subprocessors page. Tests may include, but are not limited to, the following:

  • Genetic Testing. The Testing Laboratory, on behalf of Bioscope and your health care provider, may perform whole genome sequencing, which is a genetic test. The sequencing is performed on DNA extracted from a biological sample. The purpose of this testing is to analyze DNA to find any genetic variants, including common variants and abnormal variants that might cause disease, make it more likely to develop a disease, and/or increase the chance of having a child affected by a disease. The testing may also identify other genetic variants, characteristics, and traits, and identify ancestry information. Whole genomic sequencing examines essentially all of the DNA in the human genetic code, including coding and non-coding regions.

  • Microbiome Analysis. The Testing Laboratory on behalf of Bioscope and your health care provider, may perform microbiome analysis. This test analyzes microbial DNA from a collected stool sample to identify microbial compositions, patterns, and characteristics that may assist your health care provider in clinical decision-making. Any human DNA incidentally captured during this process is handled as described in the Purpose and Implications of Testing section above.

Possible Results and Significance of the Results
The results of your test(s) will depend on the type of test performed. Your health care provider will discuss your specific results with you.

Genetic Testing Results. Genetic testing aims to identify a wide variety of genetic variants, genetic characteristics, and genetic trait correlation. The results of the test could provide information about the geographic origins of your ancestors and provide insights into your genetic traits. The results may also provide you with information about you or your genetic relatives that you do not expect or that makes you uncomfortable, such as potential health risks. Results of genetic tests could also reveal that reported familial relationships are not true biological relationships. Moreover, the genetic test could include findings that are:

  • Positive, meaning some variants have been identified that are known to cause disease symptoms or impact the effectiveness or safety of a particular medication based on available scientific evidence at the time of testing. Results that indicate that some variants may (i) contribute to the diagnosis of a genetic condition or impact how your health care provider treats a health condition, (ii) reveal carrier status for a genetic condition, (iii) reveal a predisposition or an increased risk for developing a genetic disease in the future, or (iv) have implications for other family members. If the results of your genetic test come back as positive for certain variants, confirmatory testing by a CLIA-certified method may be recommended before clinical decisions are made, as the bioinformatics pipeline used to analyze whole genome sequencing data is not separately CLIA-certified. You should consult with your health care provider or pursue genetic counseling to determine appropriate next steps.
  • Indeterminate, meaning some variants have been identified that could potentially contribute to disease symptoms, but there is no conclusive evidence either way. An indeterminate result may (i) lead to a suggestion that testing additional family members may be helpful, (ii) remain uncertain for the foreseeable future, or (iii) be resolved over time.
  • Negative, meaning some variants that are known or likely to cause disease symptoms or impact the effectiveness or safety of a particular medication based on the available scientific evidence at the time of testing have not been identified. Such results may (i) reduce but not eliminate the possibility that any of your diagnosed health conditions has a genetic basis, (ii) impact how your health care provider treats your health condition, (iii) reduce but not eliminate your predisposition or risk for developing a genetic disease in the future, or (iv) be uninformative. As noted above, the bioinformatics pipeline used to analyze whole genome sequencing data is not separately CLIA-certified. A negative result does not definitively rule out a genetic condition, and confirmatory testing through a CLIA-certified method may be recommended, particularly if there is a strong clinical suspicion or family history.

Microbiome Test Results. Results of microbiome analysis may provide information about your microbial composition and related health indicators. These results reflect a point in time analysis and may change over time due to environmental, dietary, or other factors. Your health care provider will interpret these results in the context of your overall health and medical history.

Limitations and Effectiveness of Testing
Please note that laboratory tests, including genetic tests, are not definitive. Due to limitations in technology or incomplete medical knowledge, some clinically significant findings may not be detected. Therefore, it is not possible to completely exclude all risks for all possible conditions for you and your family members, including your children. Moreover, in some cases, a test may indicate an abnormality that does not correspond to a clinical condition, or may fail to detect a condition that is present. There may also be possible sources of error including, but not limited to, trace contamination, rare technical errors in the laboratory, rare variants that compromise data analysis, inconsistent scientific classification systems, and inaccurate reporting of family relationships or clinical diagnosis information.

Additional Limitations Specific to Whole Genome Sequencing: Certain regions of the genome are technically difficult to sequence and may not be fully analyzed. WGS may not detect all types of genetic changes, such as some structural rearrangements, repeat expansions, epigenetic modifications, or somatic (non-inherited) mutations. A normal or negative result does not guarantee the absence of genetic disease. The presence of a genetic variant does not necessarily mean you will develop a disease; many factors, including environment and lifestyle, contribute to health outcomes. The interpretation of your results reflects the state of scientific knowledge at the time of analysis and may change as new information becomes available.

Additional Limitations Specific to Microbiome Testing: Microbiome test results reflect a point-in-time snapshot and may change over time due to environmental, dietary, or other factors.

Performance of the Testing
If you sign this Consent Form, one or more laboratory tests as ordered by your health care provider (each, a “Test”) will be performed on a sample containing your biological materials, collected using the method specified in your Sample collection kit (the “Sample”). A qualified laboratory or testing service provider that has been contracted to conduct the testing (the “Testing Laboratory”) will perform the Test. A current list of Testing Laboratories is available at security.bioscope.ai/legal/subprocessors. The results of the Test and the analytical data and other data derived from the Test (collectively, “Test Data”) will be disclosed back to Bioscope for processing in the Bioscope software application. Test Data may include genomic sequencing data and other genetic data (“Genetic Data”), and microbiome composition data, depending on the type of Test performed. Bioscope will make the results of the Test available to your healthcare provider who will discuss the results with you. Depending on your state of residence, you may have the right to receive a copy of the results of the Test. If you would like to request to receive a copy of the results of the test, please contact your health care provider.

Sample Collection
Your health care provider will provide you with a Sample collection kit or have one delivered to a mailing address of your choosing, which you will use to collect a Sample using the collection method specified in the kit instructions (e.g., cheek swab, stool sample, blood draw, or other biological specimen). The Sample collection kit will include the information and material you need to send the Sample to the Testing Laboratory. The Sample will only be used to perform the Test. No other tests will be performed on the Sample. You have the right to have your Sample destroyed after completion of the Test, and the Sample will be destroyed after the testing services have been provided.

Your Role in Deciding What You Want to Know

Whole genome sequencing can generate a large amount of information, not all of which may be relevant or desired by every patient. You and your health care provider will work together to determine which results are shared with you and discussed, based on your personal preferences, values, and medical circumstances. You are encouraged to have an open conversation with your health care provider — before and after testing — about what types of information you do and do not wish to learn.

Please understand, however, that your ordering health care provider will have access to your complete genomic results. This is necessary so that your health care provider can fulfill their professional obligation to manage your care appropriately and to identify any findings that may require urgent or time-sensitive medical attention. Your health care provider may use their clinical judgment to initiate a conversation with you about specific findings if, in their professional opinion, the information is important to your health or safety, even if you have expressed a general preference not to receive certain categories of results.

Privacy and Confidentiality
In order to perform the Test and provide you with the services you have requested, in addition to the Sample, your health care provider will disclose certain personal data about you to Bioscope, including your name, address, date of birth, sex, information related to your medical history, and other health information (“Sensitive Data”). Bioscope will also receive the Test Data, which may include Genetic Data and other analytical data generated from the Test.

Bioscope adheres to the privacy and security requirements of the Health Insurance Portability and Accountability Act of 1996, as amended, and the regulations promulgated thereunder, including the HIPAA Privacy Rule, HIPAA Security Rule, and Breach Notification Rule (collectively, “HIPAA”). Bioscope maintains administrative, physical, and technical safeguards designed to protect the confidentiality, integrity, and availability of your Sensitive Data and Test Data, including any Genetic Data and electronic protected health information, in accordance with HIPAA. All Testing Laboratories and other service providers engaged by Bioscope that create, receive, maintain, or transmit your protected health information are contractually required to adhere to HIPAA privacy and security requirements and to maintain safeguards that provide the same level of protection for your information as required under Bioscope’s own obligations.

You have the right to confidential treatment of your Sample, Sensitive Data, and Test Data (including any Genetic Data). The Testing Laboratory(ies) and their service providers will only be provided with the minimum necessary Sensitive Data to perform the Test. Access to the Sample, Sensitive Data, and Test Data is otherwise limited to your health care provider and Bioscope.

The Sample, Sensitive Data, and Test Data will be used, disclosed, and otherwise processed for the purpose of the performance of the Test and associated services, including processing the Test Data and Sensitive Data in the Bioscope software solution, which includes the use of artificial intelligence to process the Test Data and Sensitive Data. Bioscope may retain and use the Sensitive Data and Test Data for internal research, product development, and quality assurance testing to improve its products and services. The Sample, Sensitive Data, and Test Data may also be used, disclosed, and otherwise processed for purposes otherwise permitted or required by applicable law. Bioscope will retain the Test Data and Sensitive Data for as long as necessary to provide the services associated with the Test.

Bioscope may also deidentify Sensitive Data and Test Data and analyze that deidentified data for statistical or any other purposes permitted by law. The Sensitive Data and Test Data will be retained for the time needed to provide the testing services and associated services or as is required to comply with applicable laws and regulations. The results of the Test and Test Data will only be released to your health care provider, Bioscope and its service providers, those individuals you have authorized to receive the results in writing, and those allowed access to the results by law.

Keeping You Informed About Research Opportunities

Medical research depends on people like you who are willing to contribute to scientific discovery. From time to time, there may be research studies or programs — conducted by Bioscope or in partnership with universities, hospitals, or other research organizations — that could benefit from your participation.

We’d like your permission to let you know about these opportunities when they arise. Here’s what this means:

  • You decide whether you want to learn more or participate — there’s no obligation
  • Your data stays private — we will never share your Test Data, Genetic Data, or health information with anyone unless you specifically authorize it at that time
  • Your care isn’t affected — whether you participate or not has no impact on your relationship with your healthcare provider or access to Bioscope services
  • You can opt out anytime — just let us know at privacy@bioscope.ai

Your Rights
Depending on your state of residence, you may have certain rights with respect to your Test Data (including Genetic Data) and Sensitive Data. Those rights may include:

  • The right to inspect and obtain your Test Data, including any Genetic Data.
  • The right to request correction of your Test Data, including any Genetic Data.
  • The right to request the destruction of your Test Data, including any Genetic Data.

You may exercise your rights by contacting your health care provider.

The testing discussed in this Consent Form is voluntary. You are not required to consent to the collection, use, and disclosure of your Sensitive Data, Sample, and Test Data for the purposes described above. However, if you do not consent, your health care provider will not be able to order the testing for you, as the collection, use, and disclosure of your Sensitive Data, Sample, and Test Data is necessary to conduct the Test and provide the results. If you consent, you have the right to withdraw your consent by contacting your health care provider.

State-Specific Notices

The following supplemental notices apply based on your state of residence. These notices are in addition to, and do not replace, the terms of this Consent Form.

Notice for Oregon Residents

If you are a resident of the State of Oregon, the following additional disclosures apply to you pursuant to Oregon’s Genetic Privacy Law (ORS 192.531–192.549):

Genetic Information Confidentiality. Under Oregon law, your genetic information is your property. The collection, use, retention, and disclosure of your genetic information is subject to the confidentiality protections of ORS 192.531 through 192.549. Genetic information obtained from you will not be disclosed without your informed consent except as permitted by law.

Risks of Disclosure. You should be aware that, despite legal protections, there are potential consequences if your genetic test results or genetic data become known to others, including potential effects on your insurability, employability, and the risk of social discrimination. Federal law (the Genetic Information Nondiscrimination Act, or “GINA”) provides certain protections against discrimination based on genetic information by health insurers and employers. However, these protections may not extend to all types of insurance, such as life, disability, or long-term care insurance.

Insurance and Payment. Bioscope does not submit testing to insurance and does not collect payment from patients. Your financial relationship is solely with your health care provider. If your health care provider submits testing to a third-party payer (such as an insurance company) on your behalf, that submission may involve disclosure of information about the test(s) ordered. You should discuss any payment and insurance questions with your health care provider.

Right to Sample Destruction. Under Oregon law, you have the right to have your DNA sample and other biological specimens destroyed promptly after the specific purpose for which they were collected has been fulfilled, unless you have expressly authorized their retention for a longer period.

Support Services. Genetic counseling and other support services may be available to help you understand the implications of your test results. Contact your health care provider for information about available support services, including how to locate a genetic counselor.

Voluntariness and Right to Withdraw. Genetic testing is voluntary. You have the right to withdraw your consent at any time. Upon withdrawal, your Sample will be destroyed and no further testing will be performed.

Further Questions
If you have any further questions about the information contained in this Consent Form, please contact your health care provider.

Authorization
By signing this Consent Form, I confirm that I have received, read, and understood the preceding written explanation about laboratory testing, including genetic testing and microbiome analysis. I have been adequately informed regarding the purpose, scope, type, and significance of such analysis and its possible results. I understand that testing is voluntary. Furthermore, I confirm that I have had sufficient opportunities to ask questions, and such questions were answered in an understandable manner and to my full satisfaction.

I hereby give consent to Bioscope and the Testing Laboratory(ies) to collect my Sample(s) and perform the Test(s) on my Sample(s).

I hereby consent to the collection, use, disclosure, and other processing of my Sensitive Data and Test Data (including any Genetic Data) for the purposes of the provision of the testing services as described above.

I understand that human DNA incidentally captured during microbiome testing will not be individually analyzed or reported as described above.

I understand that my ordering health care provider will have access to my complete genomic results and may use their clinical judgment to discuss specific findings with me, as described in the “Your Role in Deciding What You Want to Know” section above.

Last Updated: March 11, 2026