• BRACAnalysis CDx was the first FDA approved companion diagnostic for treatment in patients with ovarian cancer and metastatic breast cancer who have a germline BRCA1 or BRCA2 mutation.
  • BRACAnalysis CDx is also a complementary diagnostic for maintenance therapy in patients with ovarian cancer who have a germline BRCA1 or BRCA2 mutation.

BRACAnalysis CDx Indications for ovarian cancer

Companion Diagnostic:

  • Treatment with Lynparza for patients with metastatic breast cancer
  • 4th line treatment with Lynparza for patients with ovarian cancer

Complementary Diagnostic:

2nd line maintenance therapy in ovarian cancer with Zejula


Mechanism of Action: BRCA and PARP

1

Normal Cells:
endogenous DNA damage


polyADP ribose polymerase (PARP) and BRCA both function to repair DNA

2

Tumor Cells:
DNA damage


Tumors with BRCA mutations already have a DNA repair defect

3

Tumor Cells:
DNA damage


Inhibiting PARP in BRCA deficient cells prevents the cell from replicating- effectively killing the cancer cells


BRACAnalysis CDx is intended to detect germline BRCA1 and BRCA2 variants and provide a clinical interpretation of the identified variants.

All components are incorporated in Myriad’s FDA-approved device.


PARPi Indications for Use

PARP Indication Companion Complementary Publication
Lynparza Metastatic Breast Cancer Treatment for patients at any age
Jan 2018
  Robson et al. N Engl J Med (2017). 10.1056/NEJMoa1706450
Lynparza Ovarian Cancer 4th line+ treatment
Dec 2014
2nd line+ maintenance therapy
March 2017
Kaufman et al.
Zejula Ovarian Cancer   2nd line+ maintenance therapy
March 2017 therapy
Mirza et al. N Engl J Med. (2016). 375:2154-2164.