Kit & Report Order Terms

These Kit & Report Order Terms ("Kit Terms") govern the purchase and processing of whole genome sequencing (WGS) kits, the purchase of lifestyle reports and digital products, and Bring Your Own Data (BYOD) uploads, from Mosaic Biodata Inc. ("Mosaic," "we," "us," or "our"). By purchasing a kit, you ("Customer," "you," or "your") agree to these Kit Terms, our Terms of Service, Privacy Policy, and Genetic Data Consent Notice.

Service Description

What We Provide:

Whole Genome Sequencing (WGS) using advanced Next Generation Sequencing technology (Complete Genomics T7 with DNBSEQ™ or equivalent)

Coverage of approximately 3 billion nucleotides at an average of 30x depth

Pseudonymized VCF file aligned to GRCh38/hg38 reference genome

Access to genetic data through your Mosaic account

Bring Your Own Data (BYOD):

You can upload VCF files from third-party genetic testing providers (for example, whole-genome sequencing from other laboratories, or files from 23andMe, AncestryDNA, and Nebula Genomics) and run Mosaic reports on them.

Creating an account and uploading your file are free; we confirm the file is processable before any charge.

Running a report on an approved upload is a paid service; the available report options and their pricing are shown at checkout. File-format and quality requirements apply, and not all files are compatible with our analysis.

BYOD files are handled per the Data Storage & Retention Terms; we do not guarantee ongoing storage of BYOD files, so keep your own copy.

Lifestyle Reports: Lifestyle reports (nutrition, fitness, sleep, hormones, athletics) are purchased separately or as part of bundled packages. These Kit Terms govern the purchase, processing, shipping, and refund of the WGS kit and the purchase of lifestyle reports and related digital products.

Clinical decision support is available separately through Clara, governed by the Clara Subscription Terms and a mandatory Clara Business Associate Agreement. These Kit Terms do not cover Clara.

Non-Medical Use and Limitations: This service provides whole genome sequencing data for informational and educational purposes only. It does not provide, and should not be used for:

Medical diagnosis, prognosis, or treatment recommendations

Clinical genetic testing or medical decision-making

Pharmacogenomic prescribing information

Reproductive, fertility, or prenatal counseling

Mental health assessment or psychological evaluation

Prediction or diagnosis of disease or medical conditions

Always consult a qualified healthcare professional or genetic counselor for medical interpretation of genetic information or to make informed health-related decisions about your health.

Sequencing Coverage Limitations: Our sequencing does not analyze all genomic regions. Some regions have low or no coverage, including centromeres, highly repetitive sequences, complex structural variants, and portions of the Y chromosome and mitochondrial DNA. Not all variant types (rare variants, structural variations, copy number variations, epigenetic modifications) may be detected or included in your VCF file.

Kit Purchase

What's Included:

DNA collection kit with cheek swabs and collection vials

Detailed collection instructions

Prepaid return shipping label (U.S. customers only)

Laboratory processing by a CLIA-, COLA-, CAP-, and AABB-accredited laboratory partner

VCF file delivery to your Mosaic account

Payment Terms:

All prices in USD

Payment processed via a PCI-compliant payment processor

Applicable sales tax added at checkout based on shipping address.

Payment method securely stored for future transactions

Shipping:

United States: Customer pays outbound shipping at checkout (1-2 business days); free prepaid return shipping label to the lab included

International: Customer is responsible for all shipping costs (delivery and return), customs clearance, import permits, duties, taxes, and VAT

Kit Activation and Registration

Activation Requirements: You must activate your kit online at https://mosaicbio.io/activate before or immediately after returning your sample. Activation:

Links the kit number to your Mosaic account

Requires completion of the Genetic Data Consent Notice

Must occur within 30 days of laboratory receipt, or the sample will be destroyed with no data generated and no refund issued.

Account Requirements:

Must be 18+ years old or have parental/guardian consent

Required information: Name, email, date of birth, shipping address

You confirm the sample is your own DNA, or you have legal authorization to submit it.

You confirm that providing samples complies with export laws in your country.

Sample Collection and Return

Collection Instructions:

Firmly scrape the inside of each cheek with the provided swabs.

Do not eat, drink, smoke, or chew gum for 1 hour before collection.

Snap the swabs into the provided collection vials and seal them, following the kit instructions.

Store at room temperature after collection.

Return Deadlines:

Return kit within 180 days of purchase or before kit expiration date (whichever comes first)

Kits received after the deadline will not be processed.

No extensions available for expired kits

Sample Quality Requirements: For successful processing, samples must have:

Adequate cell collection from a firm cheek scrape with both swabs

No contamination from food particles, blood, or other substances

Proper storage and timely return per instructions

Laboratory Processing

Processing Facility:

CLIA-, COLA-, CAP-, and AABB-accredited laboratory partner

Federally regulated under Clinical Laboratory Improvement Amendments (CLIA)

Secure chain of custody and sample tracking protocols

Quality management and quality control systems

Data Flow:

User → Mosaic → Laboratory Partner → Mosaic → User

The laboratory partner:

Receives the cheek-swab sample with kit number only (no personal identifiers)

Performs whole genome sequencing using Next Generation Sequencing technology

Generates a pseudonymized VCF file aligned to the GRCh38/hg38 reference genome

Transmits VCF file to Mosaic via encrypted API

Destroys the physical sample immediately after successful sequencing

Does not retain genetic data or personal information

Processing Timeline:

15–20 days from laboratory sample receipt to data availability

Timeline not guaranteed and may vary based on laboratory capacity, sample quality, or technical issues.

No refunds issued for processing delays

Real-time progress tracking is available in your account dashboard

Processing Stages:

Sample received at the laboratory

DNA extraction and quality assessment

Whole genome sequencing

Bioinformatics analysis and variant calling.

VCF file generation and quality control

Data delivery to your Mosaic account

Data Delivery:

VCF file delivered to secure Mosaic account

Email notification when results are ready

24/7 access to data once delivered

Sample Destruction: Physical samples are destroyed immediately after successful processing using approved biomedical waste disposal procedures. No physical samples are retained.

Data Storage, Security, and Compliance

Storage Infrastructure:

Location: All genetic data is stored in the United States data centers

No data storage in foreign jurisdictions

Access is restricted from foreign adversary entities

Security Measures:

Encryption: AES-256 at rest, TLS 1.3 in transit

Access Controls: Multi-factor authentication, role-based permissions

Monitoring: 24/7 security monitoring and intrusion detection

Audits: Regular third-party security assessments

Regulatory Compliance:

Federal Requirements:

CLIA: Sequencing performed by CLIA-, COLA-, CAP-, and AABB-accredited laboratory partner

GINA: Compliance with Genetic Information Nondiscrimination Act

U.S. Department of Justice rules on bulk sensitive-data transfers to countries of concern (in effect), consistent with our U.S.-only storage of genetic data

State Requirements:

California Genetic Information Privacy Act (GIPA)

The Texas Data Privacy and Security Act and Texas genetic-privacy law

Compliance with applicable state consumer protection and genetic privacy laws

International Requirements:

GDPR (EU/UK): Article 9 special category data protection

PIPEDA (Canada): Personal information protection standards

LGPD (Brazil): Sensitive data handling requirements

Compliance with local laws where services are offered

Prohibited Access:

We prohibit access to genetic data by entities or persons from countries of concern designated under the U.S. Department of Justice Bulk Data Rule (28 CFR Part 202), and any entity or person subject to the jurisdiction of those countries.

International Data Transfers:

For International Users: Your data is transferred to and stored in the United States. We implement appropriate safeguards for international data protection compliance:

EU/UK Residents (GDPR):

Standard Contractual Clauses (SCCs) with cloud infrastructure providers

Right to detailed information about safeguards (contact support@mosaicbio.io)

Right to object to international transfers.

Right to lodge a complaint with your supervisory authority.

Right to delete data at any time

Other Jurisdictions:

Compliance with PIPEDA (Canada), LGPD (Brazil), and applicable local laws

Appropriate legal mechanisms for data transfers

Enhanced security measures for cross-border data protection

Reprocessing and Refund Policy

Non-Refundable Purchase: All kit purchases are final and non-refundable, except as specified below.

Reports and Digital Purchases: Lifestyle reports and other digital products, whether purchased individually or as part of a bundle, are separate from the kit. Because they are digital products delivered to your account, all report and digital-product purchases are final and non-refundable.

Sample Processing Failures: If your sample fails processing due to insufficient DNA quantity, poor DNA quality, or contamination:

First Failure: Automatic reprocessing using the remaining sample at no charge

Second Failure: Refund of kit purchase price minus $20 processing fee

After receiving a refund, you may purchase a new kit if you wish to attempt testing again. The $20 processing fee covers laboratory handling, quality assessment, and administrative costs.

No Refunds Provided For:

Unactivated kits (not activated within 30 days of lab receipt)

Expired kits (returned after 180-day deadline or expiration date)

Processing delays regardless of duration

Change of mind after sample submission

Dissatisfaction with VCF file content or coverage

Customer-caused sample quality issues (contamination, insufficient volume, improper storage)

Refund Processing:

Approved refunds processed within 5-10 business days

Refunded to the original payment method

Written confirmation provided upon completion

Data Ownership and Access Rights

Your Ownership

You retain complete ownership of your genetic data. We process and store it only as authorized in our Privacy Policy and Genetic Data Consent Notice.

Initial Free Access Period

You receive 30 days of free data storage and access beginning when your VCF file results become available in your account. During this period, you may:

View your VCF file and reports unlimited times.

Download your VCF file.

Share or export your data to third-party services

Request permanent deletion at any time.

Continued Access After the Initial Period

Your raw genomic data file and your current report remain available in your account at no charge. There is no storage subscription or storage fee.

Your raw data file stays accessible to view and download until you request deletion.

Your current report stays viewable in your account.

When a report is updated to a new version, we do not keep the older version on file. We recommend downloading your report PDF and keeping your own copy whenever a new version is generated.

You can purchase a refreshed report from your stored raw data at any time. Report regeneration is a paid service; no new sample or sequencing is required.

Data Portability Rights

You may download your VCF file in industry-standard, machine-readable formats from your account at any time. We strongly recommend downloading and keeping your own backup copy of your data and each report version.

Data Deletion Rights

You may request permanent deletion of your genetic data (VCF file and reports) at any time:

Deletion Request: Submit via account settings or email support@mosaicbio.io

Processing Timeline: Completed within 30 days with written confirmation

Irreversible: Deletion is permanent and cannot be undone.

Legal Retention: Limited data may be retained for legal/regulatory compliance (transaction records, tax documentation)

Data Retention

Genetic data (raw data file and current report): Retained in your account until you request deletion. There is no subscription or storage fee.

After Deletion Request: Genetic data will be permanently deleted within 30 days

Transaction Records: Retained for 7 years for tax and regulatory compliance (separate from genetic data)

Sequencing Technology and Limitations

Technology Used:

Next Generation Sequencing (Complete Genomics T7 with DNBSEQ™ or equivalent platforms)

Average 30x genome coverage

Alignment to GRCh38/hg38 reference genome

Industry-standard bioinformatics pipelines for variant calling.

Technical Limitations:

Coverage Gaps: The following genomic regions may have low or no coverage:

Centromeric regions and heterochromatin

Highly repetitive sequences and tandem repeats.

Complex structural variants and inversions

Segmental duplications and pseudogenes

Portions of the Y chromosome and mitochondrial DNA

Variant Detection Limitations:

No-Call Regions: Areas where sequencing data doesn't meet quality thresholds

Rare Variants: Many rare genetic variants may not be detected

Structural Variations: Large insertions, deletions, or rearrangements may be missed

Copy Number Variations: Changes in gene copy number may not be detected

Epigenetic Modifications: DNA methylation and other epigenetic changes are not analyzed.

Analysis Limitations:

Reference Genome Bias: Analysis based on reference genomes that may not represent all populations

Algorithm Constraints: Bioinformatics tools have inherent accuracy limitations

Population Bias: Most genetic research is conducted on European ancestry populations

Complex Inheritance: Difficulty analyzing complex genetic interactions (epistasis)

Scientific Evolution:

Genetic science is continually evolving; interpretations may change as research advances.

Variant annotations are updated regularly in genetic databases.

Discoveries may change the understanding of variant effects.

Most genetic variants have small effect sizes for complex traits

Risks and Important Considerations

Privacy and Security Risks:

Data Permanence: Genetic data cannot be changed and has lifelong implications

Re-identification: Even pseudonymized genetic data carries potential re-identification risks

Family Privacy: Your genetic data reveals information about biological relatives who have not consented

Future Unknown Uses: Unknown future applications of genetic data may pose unforeseen privacy risks

Third-Party Exposure: Sharing data with third parties increases privacy exposure

For complete information about risks, see our Genetic Data Consent Notice.

Discrimination and Legal Risks:

The Genetic Information Nondiscrimination Act (GINA) provides federal employment and health insurance protections, but does NOT cover:

Life insurance

Disability insurance

Long-term care insurance

State and international protections vary. See our Genetic Data Consent Notice for complete details.

Your Responsibilities:

Consider potential emotional impact before testing.

Understand that genetic information does not determine health outcomes.

Review third-party privacy policies carefully before sharing VCF data.

Consult healthcare professionals or genetic counselors for medical interpretation.

Consider implications for biological family members.

Third-Party Data Sharing

Your Right to Share: You may download your VCF file and share it with third-party applications for additional analysis, interpretation, or research purposes.

Critical Limitations:

No Control: Once shared, we cannot control how third parties use, store, or protect your genetic data

Independent Policies: Third-party services operate under their own privacy policies, terms of service, and security standards that may differ significantly from ours

Your Responsibility: You are solely responsible for:

Reviewing third-party privacy policies and terms before sharing

Understanding how third parties will use your data

Accepting risks associated with third-party data handling

Consequences of third-party data breaches or misuse

Data Recovery: Genetic data shared with third parties cannot be retrieved or deleted by us

Revocable Access: You can revoke third-party access to your Mosaic account anytime, but this does not affect data already shared

No Liability: We are not liable for third-party data handling practices, security breaches, commercial use, or any other third-party actions involving your genetic data

Recommendation: Only share genetic data with trusted, reputable services after carefully reviewing their data handling practices and considering long-term privacy implications.

International Customers

Service Availability: Services available in select countries worldwide, subject to:

Compliance with local genetic testing regulations

Compliance with biological sample import/export restrictions

Compliance with local data protection laws

No prohibition on genetic testing services in the customer's jurisdiction

Customer Responsibilities:

Legal Compliance:

You confirm that genetic testing is legal in your country.

You confirm that providing samples complies with export laws in your country.

You are responsible for obtaining any required permits or approvals

Shipping and Customs:

You pay all international shipping costs (delivery and return)

You are responsible for all customs clearance fees, import duties, taxes, and VAT.

You ensure samples clear customs in both the origin and destination countries.

You accept responsibility for any shipment delays or customs issues

Processing Considerations:

International samples may experience additional processing delays.

Some countries may require special documentation or permits.

Regulatory requirements may affect service availability or features

Limitation of Liability

Maximum Liability: Our total liability for any claims arising from these Kit Terms is limited to the amount you paid for the WGS kit.

Excluded Damages: To the maximum extent permitted by law, we are not liable for:

Indirect, incidental, special, consequential, or punitive damages

Lost profits, revenue, or business opportunities

Emotional distress, psychological harm, or mental anguish

Loss of data or information (except as required by law)

Third-party claims arising from your sharing of genetic data

Processing delays, service interruptions, or force majeure events

Accuracy, completeness, or interpretation of sequencing results

Medical decisions or health outcomes based on genetic data

Disclaimer of Warranties: Services provided "AS IS" and "AS AVAILABLE" without warranties of any kind, express or implied, including:

No warranty of merchantability or fitness for a particular purpose

No warranty regarding accuracy, reliability, or completeness of results

No warranty of uninterrupted or error-free service

No warranty regarding specific sequencing coverage or variant detection

No warranty regarding compatibility with third-party services

Essential Purpose: These limitations apply even if any limited remedy fails of its essential purpose.

Jurisdictional Variations: Some jurisdictions do not permit the limitation of certain warranties or damages. In such jurisdictions, our liability is limited to the maximum extent permitted by law.

Modifications to Terms

Notice of Changes: We reserve the right to modify these Kit Terms to reflect changes in law, technology, or business practices. We will provide notice as follows:

Material Changes: 30 days' advance notice via email to the registered address

Minor Changes: 7-day notice for clarifications or non-material updates

Price Changes: 60 days' advance notice for price increases

Legal Requirements: Immediate implementation when required by law or regulation

Material changes include: changes to refund policy, data handling practices, processing procedures, limitation of liability, or dispute resolution.

Your Options:

Accept Changes: Continuing to use services constitutes acceptance.

Reject Changes: Cancel pending orders before the effective date.

Request Refund: Request a refund for prepaid services before the effective date (if materially adverse)

Existing Orders: Orders placed before the effective date of changes will be processed under the terms in effect at the time of purchase, where feasible.

Dispute Resolution

Disputes related to kit orders are subject to the dispute resolution procedures in our Terms of Service, including:

60-day informal resolution period

Binding arbitration administered by JAMS

Individual claims only (no class actions)

Texas venue for non-arbitrated disputes

Contact Information

Customer Support:

Email: support@mosaicbio.io (Include "Kit Order" in subject line)

Response Time: 24-48 hours for standard inquiries; 4-8 hours for urgent issues

Support Hours: Monday-Friday, 9:00 AM - 6:00 PM Central Time

Mailing Address:

Mosaic Biodata Inc. 919 Congress Ave, Suite 525 Austin, TX 78701 United States

Corporate Information:

Incorporated: Texas, United States

Principal Place of Business: Texas, United States

Entire Agreement

These Kit Terms, together with our Terms of Service, Privacy Policy, Genetic Data Consent Notice, and other referenced policies, constitute the complete agreement between you and Mosaic regarding the purchase and processing of WGS kits.

By purchasing a WGS kit, you acknowledge that you have read, understood, and agree to these Kit & Report Order Terms.