Informed Consent for Personal and Genetic Data Processing

By checking the corresponding acknowledgment box during checkout or account registration on omninome.com, you ("the Client" or "Data Subject") freely, explicitly, and unequivocally provide your informed consent to Omninome Inc. (1309 Coffeen Avenue STE 1200, Sheridan, WY 82801, USA; Email: info@omninome.com; Phone: +1 (800) 555-0199) ("the Operator" or "Company") to process your personal and sensitive health/genetic data under the following terms:

1. Categories of Processed Data

The Operator may collect and process:

  1. Identification & Contact Data: Full legal name, date of birth, biological sex, phone number, email address, and shipping address.
  2. Health & Clinical Context: Relevant medical history, clinical symptoms, family pedigree details, and physician referrals voluntarily submitted for clinical curation.
  3. Genetic & Biometric Data: Biological samples (saliva or peripheral blood), raw sequencing data (FASTQ, BAM, CRAM, VCF, CEL, or genotyping text files), variant calls, metabolizer phenotypes, and interpretive clinical reports.
  4. Technical & Audit Metadata: IP addresses, browser cookies, consent session hashes, and access audit timestamps.

2. Purposes of Data Processing

Your data is processed strictly for:

  1. Fulfillment of genetic testing services, sample intake, DNA extraction, high-throughput sequencing, and bioinformatics analysis.
  2. Generating personalized clinical genetics, pharmacogenomics, carrier screening, and microbiome reports.
  3. Providing access to your encrypted patient portal and ongoing clinical re-interpretation as medical guidelines evolve.
  4. Answering customer inquiries and providing professional genetic counseling support.
  5. Compliance with applicable healthcare, laboratory quality accreditation, and statutory data retention laws.

3. Data Protection and Pseudonymization

The Operator enforces strict end-to-end security measures:

  1. Pseudonymization: Biological samples and raw genomic data files are stripped of direct personal identifiers and tracked solely via random alphanumeric barcodes.
  2. Encryption: All data at rest is encrypted using AES-256 standards, and data in transit is protected using TLS 1.3 encryption.
  3. Access Controls: Only authorized personnel with mandatory confidentiality commitments have access to identified health records.

4. Third-Party Laboratory Partners

To perform sequencing and clinical analysis, the Operator may transfer pseudonymized biological samples and raw sequence files to CLIA-certified and CAP-accredited partner laboratories and cloud compute infrastructure (e.g. AWS GovCloud / HIPAA-compliant data centers). Third parties are bound by strict Business Associate and Data Processing Agreements prohibiting any secondary use or unauthorized disclosure.

5. Retention and Revocation

  1. Personal and genetic data will be retained for the duration of your active account or as required by applicable medical records retention regulations.
  2. You have the right to withdraw this consent at any time, request a copy of your personal data, or demand permanent deletion of your data and destruction of biological samples by contacting info@omninome.com. Withdrawal does not affect lawful processing conducted prior to revocation.