Informed Consent for Genomic Sequencing

This Informed Consent explains important information about Level Genomics whole genome sequencing, sample collection, data processing, possible results, limitations, risks, and your choices. By ordering, activating, or using a Level Genomics kit or service, you acknowledge that you have read and understood this consent and agree to the collection, sequencing, analysis, storage, and use of your sample and genetic data as described below, our Terms of Service, and our Privacy Policy.

1. What Level Genomics Provides

Level Genomics provides direct-to-consumer, informational whole genome sequencing and genomic data services. Depending on the product ordered, your service may include a saliva sample or buccal swab sample collection kit, 30x or 100x whole genome sequencing, bioinformatics processing, FASTQ, BAM, and VCF files, informational reports, data retention, reprocessing, and AI-enabled research assistance.

Level Genomics services are currently available only in the United States. Services are for informational, educational, and personal research use only. They are not clinical diagnostic services and are not intended to diagnose, prevent, treat, cure, or monitor any disease or medical condition.

2. What Whole Genome Sequencing Is

Your genome is the genetic information contained in your DNA. Whole genome sequencing attempts to read DNA across your genome, including coding and non-coding regions. Sequencing may identify genetic variants, which are differences between your DNA sequence and a reference sequence or other comparison dataset.

Whole genome sequencing can generate a large amount of information. Some information may be understandable today, some may be uncertain, and some may become more meaningful as science and databases change over time.

3. Sample Collection

You may provide a saliva sample or buccal swab sample using the kit instructions. You are responsible for collecting the sample from the correct person, using the correct kit, following the instructions, and returning the sample before the kit expires.

If you are submitting a sample for another person, including as a gift kit, the person being tested, or their parent or legal guardian, must activate the kit and provide the required consent before testing begins. For a minor or person under guardianship, the parent or legal guardian must consent and may need to complete additional verification.

4. Laboratory and Sequencing Process

Your sample will be sent to a third-party laboratory that is CLIA-certified and CAP-accredited. The Level Genomics service, reports, and AI-enabled features are offered for informational and Research Use Only purposes and are not clinical diagnostic services. Level does not represent that its consumer service is FDA cleared, FDA approved, or intended for clinical diagnosis.

The laboratory receives samples identified primarily by kit or sample barcode. Customer identifying information is not included in the electronic sequencing requisition except as needed to provide the service, but the return shipment label may display the customer's return address because of carrier requirements.

Sequencing, laboratory, and bioinformatics providers may process your sample and genomic data as needed to perform sequencing, quality control, file generation, and related services. Level receives sequencing deliverables and may process them to create customer-facing files, reports, and features.

5. What You May Receive

Your customer-facing data deliverables are FASTQ, BAM, and VCF files. If you purchase or maintain access to Level Insight or other report features, Level may provide selected informational findings, reports, reprocessing, and AI-enabled responses based on available data, product tier, quality thresholds, current scientific knowledge, and Level's analysis methods.

Level does not guarantee detection, interpretation, or reporting of any specific variant, gene, chromosome region, condition, trait, medication response, ancestry signal, carrier finding, disease-risk finding, secondary finding, incidental finding, or category of result.

6. Possible Results and Unexpected Information

Genomic sequencing and analysis may reveal information you expect, information you do not expect, or information you may find upsetting. This may include health-related variants, pharmacogenomic information, carrier status, disease-risk information, ancestry-related information, secondary or incidental findings, variants of uncertain significance, and information that may affect biological relatives.

Results may also suggest unexpected biological relationships, including misattributed parentage, unknown relatives, lack of expected relatedness, or other family relationship information. Level services are not designed or permitted for paternity, parentage, forensic, or law enforcement identification, but genetic data can sometimes reveal relationship information indirectly.

7. Limitations of Sequencing and Interpretation

Whole genome sequencing has technical and scientific limitations. Some regions of the genome are difficult to sequence or interpret, including repetitive regions, homologous regions, structural variants, copy number changes, short tandem repeats, low-complexity regions, mosaic variants, mitochondrial variants, and regions with low or uneven coverage.

Results may include false positives, false negatives, no-calls, incomplete coverage, uncertain findings, or variants that are later reclassified. A negative, absent, or unreported finding does not mean that you have no genetic risk or health risk. A positive or reported finding does not mean that you have, will develop, or will avoid a disease or condition.

Interpretation depends on available scientific evidence, public and private databases, bioinformatics pipelines, quality thresholds, and product features. These may change over time. Level is not obligated to update or reinterpret results unless reprocessing or updated findings are included in your active product or subscription.

8. Health, Medical, and Medication Decisions

Level Genomics does not provide medical advice, diagnosis, treatment, or genetic counseling. No physician order, physician review, medical director review, or genetic counseling is included unless separately stated in writing for a specific service.

Do not make medical, medication, reproductive, emergency, lifestyle, insurance, employment, or legal decisions based solely on Level results, reports, files, or AI responses. Discuss health-related findings with a qualified healthcare professional. Clinically important findings should be confirmed by an appropriate clinical test before any medical action is taken.

9. Risks and Considerations

• Privacy risk: Genetic data is uniquely identifying and sensitive. Although Level uses security measures described in our Privacy Policy, no system can be guaranteed to be completely secure.
• Emotional risk: You may learn information that is unexpected, uncertain, serious, or upsetting.
• Family implications: Your results may reveal information relevant to biological relatives, including children, parents, siblings, or extended family.
• Insurance and discrimination risk: The Genetic Information Nondiscrimination Act protects against some uses of genetic information in health insurance and employment, but it does not cover life insurance, disability insurance, long-term care insurance, or every employer or circumstance. State laws vary.
• Data interpretation risk: AI-enabled responses and reports may be incomplete, outdated, or incorrect and should be treated as informational only.

10. AI-Enabled Features

Level may use third-party AI, cloud, software, and bioinformatics providers as part of delivering the service. AI, reporting, and software providers may receive limited genomic excerpts, derived data, prompts, context, or other information as part of providing a requested feature. Level will not provide AI or reporting providers with your full genome and will use reasonable efforts to provide only the information needed to reliably answer the question or deliver the requested feature.

AI-enabled features may generate inaccurate, incomplete, or misleading information. They are not medical professionals and are not a substitute for professional medical advice, clinical genetic testing, or genetic counseling.

11. Data Files, Retention, and Deletion

If you do not maintain a Level Insight subscription, your FASTQ, BAM, and VCF files will be available for 60 days after results are made available, then deleted from Level systems unless you purchase or activate a retention service before deletion.

If you maintain an active Level Insight subscription, Level retains your genomic data while your account and subscription remain active, subject to your deletion rights and our Privacy Policy. If your Level Insight subscription ends and is not renewed, Level will delete your genomic data 30 days after the subscription term ends unless you request earlier deletion.

If you request deletion, Level will delete active Level copies within 30 days and backup copies within 90 days, unless a longer period is required by law, fraud prevention, security, dispute resolution, or legitimate business record obligations.

12. Physical Sample Handling

Physical samples and lab-side data may be retained by the laboratory for up to 60 days after reporting or upload, then discarded or deleted unless you provide separate express consent for longer retention or applicable law requires otherwise. Samples are not returned after processing.

13. Uploaded Genetic Data

Level may allow you to upload existing genetic data from another provider. Uploaded data may have different quality, completeness, file formats, sequencing methods, or error profiles than Level-generated data. Level does not guarantee that uploaded data can be processed or interpreted, or that it will produce the same results as Level-generated sequencing.

14. Voluntary Participation and Withdrawal

Your use of Level Genomics services is voluntary. You may choose not to order a kit, not to activate a kit, not to submit a sample, not to upload data, or not to use reports or AI-enabled features.

You may withdraw consent before processing begins by contacting support@levelgenomics.com. After your return package is scanned in by UPS or processing has begun, some steps may not be reversible. You may request deletion of your account, data, and sample as described in our Privacy Policy, but withdrawal does not affect processing that occurred before withdrawal.

15. Consent Acknowledgments

By agreeing to this Informed Consent for Genomic Sequencing, you acknowledge and agree that:

• You have read and understood this consent, the Terms of Service, and the Privacy Policy.
• You authorize Level and its service providers to collect, receive, sequence, process, analyze, store, transmit, and use your sample and genetic data to provide the services you request.
• You understand that Level services are informational and Research Use Only, not clinical diagnostic services.
• You understand that results may include unexpected, uncertain, health-related, family-related, or emotionally significant information.
• You understand that sequencing and interpretation have limitations and may not detect or report every variant, gene, condition, or category of finding.
• You understand that you should not make medical or medication decisions based solely on Level information and should consult qualified healthcare professionals.
• You understand the sample, data retention, deletion, and subscription-based storage policies described above.
• If you are consenting for another person, you represent that you have legal authority to do so and that the sample and data belong to the person identified during kit activation.

16. Contact

For questions about this consent or Level Genomics services, contact support@levelgenomics.com. For privacy requests, contact privacy@levelgenomics.com.