Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies And/or Population-based Analysis
Sequenom, Inc.
Summary
Patients of scientific interest who have provided a commercial sample to LabCorp or one of its' affiliates will have their de-identified remnant samples and/or data used for research and development. Other commercial patients will be followed up on after informed consent is obtained.
Description
Arm 1 - Remnant commercial samples and data that has been de-identified of personal health information in compliance with HIPAA may be used for R\&D studies or population-based analysis by LabCorp or affiliates. Arm 2 - Collection of samples and/or data from commercial test patients requiring follow-up or from subjects of scientific interest after informed consent is obtained.
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Arm 1 * All samples and data are de-identified and HIPAA compliant * Arm 2 * Subject is of scientific interest to the Sponsor or treating physician * Subject provides written informed consent and has a clinical sample and/or supporting clinical data collected. Exclusion Criteria: * Arm 1 * Subject is from a US state or a country where local law restricts the use of de-identified data and/or remnants of specimens for research and/or development * Arm 2 * Any medical or mental condition that would interfere with the subjects' ability to willingly give written informed co…
Interventions
- DeviceMultiple interventions depending on diagnostic test being run.
Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.
Location
- Sequenom, IncSan Diego, California