FDA Approves BRACAnalysis CDx as Companion Diagnostic for Olaparib in BRCA+ HER2- High-Risk Early Breast Cancer

The BRACAnalysis CDx test received FDA approval as a companion diagnostic for olaparib for the treatment of patients with germline BRCA-mutated HER2 negative high-risk early-stage breast cancer.

The FDA approved the BRACAnalysis CDx test as a companion diagnostic to identify patients with germline BRCA-mutated HER2-negative high-risk early-stage breast cancer who might derive benefit from treatment with olaparib (Lynparza), according to a press release from develop Myriad Genetics.1

Currently, BRACAnalysis CDx is the only germline test approved as a companion diagnostic for treating patients with HER2-negative high-risk early-stage breast cancer.

“This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer,” Nicole Lambert, chief operating officer at Myriad Genetics, said in a press release. “Data from the OlympiA trial and numerous other clinical studies continue to demonstrate the power of BRACAnalysis CDx as an effective test for patients deciding on their best treatment options. More patients with breast cancer now potentially qualify for BRCA testing.”

The companion test identifies deleterious germline BRCA variants in patients with HER2-negative high-risk early breast cancer. Myriad Genetics and AstraZeneca have been collaborating on the development of olaparib since 2007, resulting in previous approvals for the BRACAnalysis CDx test for patients with ovarian cancer in 2014 and for patients with HER2-negative metastatic breast cancer in 2018.

“Studies have demonstrated that PARP inhibitors are highly effective in patients with BRCA1/BRCA2 mutations. Once we identify these patients, they will have more options for treatment,” Thomas Slavin, MD, chief medical officer at Myriad Genetics, said in a press release. “This important advancement underscores the need for [patients with] breast cancer being evaluated for approved therapies to know their BRCA status with an FDA-approved test right after diagnosis to help ensure they will receive the best available therapy. Additionally, the quick adoption of OlympiA criteria by guideline committees greatly supports the advancement of genomics in clinical care.”

Adjuvant olaparib was recently approved by the FDA for treating patients with BRCA-mutated HER2-negative high-risk early breast cancer who underwent chemotherapy prior to or following surgery on the heels of positive results from the phase 3 OlympiA trial (NCT02032823.) Findings from the study identified a statistically significant improvement in invasive disease-free survival among patients in the olaparib arm vs placebo (HR, 0.58; 95% CI, 0.46-0.74; P <.0001).2 Patients in the olaparib arm experienced a risk reduction of invasive recurrence, secondary cancers, or death of 42% compared with placebo.


  1. Myriad Genetics receives FDA approval of BRACAnalysis® CDx as a companion diagnostic for Lynparza® in early breast cancer. News release. Myriad Genetics. March 11, 2022. Accessed March 14, 2022. https://tinyurl.com/4pkuemzw
  2. Tutt ANJ, Garber JE, Kaufman B, et al. Adjuvant olaparib for patients with BRCA1- or BRCA2-mutated breast cancer. N Engl J Med. 2021;384(25):2394-2405. doi:10.1056/NEJMoa2105215