Compliant Analysis of Patient Samples and Data

Use of Patient Samples and Corresponding Clinical Data for Research and Development Studies and/or Population-based Analysis

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.

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.

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 consent