Genetic Testing Consent Form (Except NV, OR, NY)
Bioscope.ai Genetic Testing Consent Form
This Genetic Testing Consent Form (“Consent Form”) will provide you with information regarding the genetic test provided by Bioscope.ai, Inc. (“Bioscope”) which your health care provider has ordered for you. You should discuss the genetic test with your health care provider or a genetic counselor. 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 Genetic Testing
The purpose of genetic testing is 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. Genetic testing can provide information that can assist your health care provider in making a diagnosis or help provide information for symptom management, treatment, or lifestyle changes. 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. Genetic testing may also be used to identify genetic characteristics and traits to provide information about how an individual will respond to medications or the effectiveness of a particular drug, which can assist your health care provider in determining which medications to prescribe.
In rare cases, persons that 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. 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 Genetic Testing
The Testing Laboratory (defined below), on behalf of Bioscope and your health care provider, will perform whole genome sequencing, which is a genetic test. This kind of genetic testing is not necessarily meant to identify one disease or condition, but instead to identify genetic characteristics and risk factors, including, but not limited to cancer, neurodegenerative disease, metabolic disorders and drug response. The sequencing is performed on DNA extracted from tissue collected 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 to identify ancestry information and predict how an individual will respond to a particular medication. Whole genomic sequencing examines essentially all of the DNA in the human genetic code, including coding and non-coding regions.
Possible Results and Significance of the Results
This genetic test 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, you may wish to consider further independent testing, consult with your health care provider or pursue genetic counseling.
- 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.
Limitations and Effectiveness of Genetic Testing
Please note that genetic tests are not definitive. Due to limitations in technology or incomplete medical knowledge, some disease-causing variants may not be detected. Therefore, it is not possible to completely exclude all risks for all possible genetic diseases for you and your family members, including your children. Moreover, in some cases, the genetic test may indicate an abnormality in a gene, however, that does not always mean a genetic disorder will manifest. In addition, the genetic test may indicate a genetic abnormality when the individual is unaffected (false positive) or may indicate no genetic abnormality when the individual is affected (false negative). There may also be possible sources of error including, but not limited to, trace contamination, rare technical errors in the laboratory, rare DNA variants that compromise data analysis, inconsistent scientific classification systems, and inaccurate reporting of family relationships or clinical diagnosis information.
Performance of the Genetic Testing
If you sign this Consent Form, a genetic test, specifically whole genome sequencing (the “Test”) will be performed on a sample containing your biological materials, collected via a cheek swab (the “Sample”). Gene by Gene, a laboratory that has been contracted to conduct the testing (the “Testing Laboratory”) will perform the Test. The results of the Test and the genomic sequencing data and other genetic data derived from the Test will be disclosed back to Bioscope for processing in the Bioscope software application. 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 a cheek swab. 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 genetic test, and the Sample will be destroyed after the genetic testing services have been provided, unless you have expressly authorized the retention of the Sample for a longer period.
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 results from the Test, the genomic sequencing data and other genetic data generated from the Test (the “Genetic Data”).
You have the right to confidential treatment of your Sample, Sensitive Data, and Genetic Data. Only your health care provider, Bioscope, and the Testing Laboratory and their respective service providers will have access to the Sample, Sensitive Data, and Genetic Data.
The Sample, Sensitive Data, and Genetic Data will be used, disclosed, and otherwise processed for the purpose of the performance of the Test and associated services, including processing the Genetic Data and Sensitive Data in the Bioscope software solution, which includes the use of artificial intelligence to process the Genetic Data and Sensitive Data. Bioscope may retain and use the Sensitive Data and Genetic Data for internal research, product development, and quality assurance testing to improve its products and services. The Sample, Sensitive Data, and Genetic Data may also be used, disclosed, and otherwise processed for purposes otherwise permitted or required by applicable law. Bioscope will retain the Genetic Data and Sensitive Data for as long as necessary to provide the services associated with the Test.
Bioscope may also deidentify Sensitive Data and Genetic Data and analyze that deidentified data for statistical or any other purposes permitted by law. The Sensitive Data and Genetic Data will be retained for the time needed to provide the genetic test and associated services or as is required to comply with applicable laws and regulations. The results of the Test and Genetic 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:
- We’ll reach out to you by email or other contact method you’ve provided to tell you about the opportunity
- You decide whether you want to learn more or participate — there’s no obligation
- Your data stays private — we will never share your 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 Genetic Data and Sensitive Data. Those rights may include:
- The right to inspect and obtain your Genetic Data.
- The right to request correction of your Genetic Data.
- The right to request the destruction of your Genetic Data.
You may exercise your rights by contacting your health care provider.
The genetic 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 Genetic Data for the purposes described above. However, if you do not consent, your health care provider will not be able to order the genetic testing for you, as the collection, use, and disclosure of your Sensitive Data, Sample, and Genetic Data is necessary to conduct the Test and provide the results. If you consent, you have the right to withdraw your consent at any time by contacting your health care provider.
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 genetic testing. I have been adequately informed regarding the purpose, scope, type, and significance of such analysis and its possible results. I understand that genetic 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 to collect my Sample and perform the Test on my Sample.
I hereby consent to the collection, use, disclosure, and other processing of my Sensitive Data and Genetic Data for the purposes of the provision of the genetic testing as described above.
Last Updated: December 8, 2025