These issues should be brought to the attention of the physicians and patients in regard to the DirectHit™ Test Panel for Breast Cancer.

• The purpose of DirectHit is to provide a tumor sensitivity/resistance profile for different drugs for an individual cancer patient.
• If a drug treatment is administered in an unconventional manner, DirectHit recommendations may not apply.
• Clinical validation of the DirectHit data was performed with first line and second line drug treatments. Application of DirectHit results to later lines of treatment is not recommended.
• DirectHit is being conducted on the tumor tissue obtained from surgical or biopsy samples. If these tumors have received drug treatment prior to collection, the expression level of the drug response indicator may or may not be affected.
• CCC Diagnostics should be notified if any drug treatments were administered before tumor tissue collection.
• DirectHit provides no information about the toxicity of FDA approved drugs. Information about the toxicity is described in the drug package insert.