Progenity - Collection of Samples for Analytical Validation of a Hereditary Cancer Gene Sequencing Panel.

Primary Objective: Obtain whole blood samples from subjects at high risk of having or having a known genomic variant within a pre-determined genomic region associated with hereditary cancer risk to determine the feasibility of performing next generation sequencing to identify genomic sequence variants previously found to be responsible for elevated risks of developing cancer.

Eligibility Criteria:

Subjects will meet one of the following criteria:

a. has results (within 2 prior years) from previous hereditary cancer genetic

screening showing a pathogenic variant (PV), or a variant of unknown


b. has a strong family history of cancer (1st degree relative – parent, child, or

sibling) OR who has at least one family member that has been identified by a

CLIA-certified/CAP-accredited reference laboratory as having a pathogenic

variant or a variant of unknown significance in the pre-determined genomic


Subjects will provided a total of 14 mL whole blood (two 7 mL EDTA tubes) at a

single visit.