Tumor Profiling Attestation & Patient Consent
Thank you for ordering Caris molecular profiling via your institution’s electronic health record system (EHR). The full and complete order attestation and patient consent is listed below.
ATTESTATION & PATIENT CONSENT
This requisition constitutes an order for molecular testing from Caris MPI, Inc. (Caris). I certify (a) the services are medically necessary and will assist me in treating my patient, (b) the patient has sufficient performance status to receive additional treatment, (c) I will make available patient medical records documenting the foregoing, and (d) I supplied information to the patient regarding this testing, explained the purpose of this testing to the patient, and obtained informed consent for (i) such testing, (ii) any analysis and reports related to such testing, (iii) Caris to retain testing results, samples and related information and analysis, (iv) Caris’ use or disclosure (including to third parties) of deidentified information generated from such testing for general research and other purposes, (v) Caris’ disclosure of testing results and information to third-party payers in connection with such testing, and (vi) for Caris to contact the patient regarding the testing.
I further attest that if this order is for concurrent tissue and blood profiling, or if both are ordered within the same 30-day period, that both tests will assist me in treating my patient and is medically necessary based on several clinical factors, which may include, oncology guidelines support concurrent testing in this disease state, turnaround time for tissue-based testing may delay important treatment decisions, or the available tissue may not meet testing requirements, among others. Additionally, I will provide any requested medical records necessary to support concurrent testing.
Additional Resources:
MI Cancer Seek Companion Diagnostic Indications
Indication |
Biomarker |
Therapy |
Breast Cancer |
PIK3CA (C420R; E542K; E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, H1047Y) |
PIQRAY® (alpelisib) |
Colorectal Cancer (CRC) |
KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4) |
VECTIBIX® (panitumumab) |
|
BRAF V600E |
BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) |
Melanoma |
BRAF V600E |
BRAF inhibitors approved by FDA* |
|
BRAF V600E or V600K |
MEKINIST® (trametinib) or BRAF/MEK inhibitor combinations approved by FDA* |
Non-Small Cell Lung Cancer (NSCLC) |
EGFR exon 19 deletions and exon 21 L858R alterations |
EGFR Tyrosine Kinase Inhibitors approved by FDA* |
Solid Tumors |
MSI-H |
KEYTRUDA® (pembrolizumab), JEMPERLI® (dostarlimab-gxly) |
Endometrial Carcinoma |
Not MSI-H |
KEYTRUDA® (pembrolizumab) in combination with LENVIMA® (lenvatinib) |
*For the most current information about the device indications for the therapeutic products in this group, go to:
https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools#Group_Labeling
PIQRAY® is a registered trademark of Novartis AG. VECTIBIX® is a registered trademark of Immunex Corporation. BRAFTOVI® is a registered trademark of Array BioPharma Inc. in the United States and various other countries. ERBITUX® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. MEKINIST® is a registered trademark of Novartis AG Corporation Switzerland. KEYTRUDA® is a registered trademark of Merck. JEMPERLI® (dostarlimab-gxly) is a registered trademark owned by the GSK group of companies. LENVIMA® (lenvatinib) is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
| Technical Info | IHC | CISH |
|---|---|---|
| Sample Requirements
(see requisition for full details) | 1 unstained slide at 4μm thickness from FFPE block, with evaluable tumor present, per IHC test | 1 unstained slide at 4μm thickness from FFPE block, with at least 100 evaluable tumor cells present, per CISH test |
| Sensitivity/Specificity | >95% | >95% |