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Myriad Genetics announced that the FDA approved its test to identify patients with high-risk early-stage breast cancer.

Myriad is bringing high-risk, early-stage breast cancer to light

Each of us likely has a personal connection to the morbid effects of cancer. Whether through a friend, colleague, family member, or perhaps ourselves, these effects are felt deeply. Our world is still struggling to combat cancer with safe and effective diagnostic and therapeutic tools. 

The Breast Cancer Research Foundation reported that breast cancer is the most common cancer worldwide—surpassing lung cancer for the first time in 2020—and the most common cancer diagnosed in American women. It is a leading cause of cancer death in less developed countries and the second leading cause of cancer death in American women. Driving this devastating mortality rate worldwide are multiple factors, ranging from access to care, lack of resources in many settings, and, notably, a delay in the initial diagnosis of cancer.

To help curtail this delay in diagnosis, Myriad Genetics of Salt Lake City—a leader in genetic testing and precision medicine—announced in mid-March that the US Food and Drug Administration (FDA) has approved its BRACAnalysis® CDx test for use as a companion diagnostic to identify patients with a specific subtype of difficult to treat (high-risk) early-stage breast cancer. The BRACAnalysis® naming stems from the well-recognized genes (BRCA1 and BRCA2) known to be associated with a higher risk for individuals to develop breast cancer throughout their lives. 

“This most recent regulatory approval confirms the benefits of using biomarkers to help guide care for patients with breast cancer,” says Nicole Lambert, COO of Myriad Genetics. “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.”

As recently reported in the New England Journal of Medicine, a mecca of clinically-relevant scientific publishing, the OlympiA trial randomized over 1,800 patients with early-stage, high-risk breast cancer to assess the efficacy of a specific therapeutic in curtailing the disease from progressing. The study’s results report that in patients with high-risk, HER2-negative early breast cancer and germline BRCA1 or BRCA2 pathogenic or likely pathogenic variants, adjuvant olaparib (Lynparza) after completion of local treatment and neoadjuvant or adjuvant chemotherapy was associated with significantly longer survival free of invasive or distant disease than was placebo. Furthermore, the authors found Olaparib had limited effects on global patient-reported quality of life. The OlympiA trial is funded by the National Cancer Institute and AstraZeneca ( number, NCT02032823).

BRACAnalysis® CDx classifies a patient’s clinically significant variants (DNA sequence variations) in the germline BRCA1 and BRCA2 genes. These detected variants are then classified into one of the five categories: “Deleterious,” “Suspected Deleterious,” “Variant of Uncertain Significance,” “Favor Polymorphism,” or “Polymorphism.” Once the classification is completed, the results are sent to medical personnel to determine patients’ eligibility for treatment with Lynparza (olaparib), an effective therapeutic against HER2-negative, high-risk early-stage breast cancer. In other words, Myriad’s new companion diagnostic test is effectively streamlining the treatment of previously difficult to detect and diagnose breast cancer, allowing these patients a significantly greater chance of barricading the cancer growth before it is too late. 

The therapeutic used in these cases of detection with BRACAnalysis® CDx is Lynparza (AstraZeneca), mentioned above. This therapy is a PARP (poly-ADP ribose polymerase) inhibitor, which neutralizes this polymerase protein, rendering it ineffective and unable to repair cancer cells as they divide and migrate. Lynparza is specifically approved by the FDA for targeted treatment of early-stage or metastatic breast cancer in patients with a confirmed BRCA gene mutation. 

“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,” says Thomas Slavin, CMO of Myriad Genetics. “This important advancement underscores the need for breast cancer patients to be evaluated for approved therapies to know their BRCA status with an FDA-approved test right after diagnosis to help ensure they receive the best available therapy. Additionally, the quick adoption of OlympiA criteria by guideline committees greatly supports the advancement of genomics in clinical care.”

Every two minutes, a woman is diagnosed with breast cancer in the United States. With breast cancer incidence rising astronomically in recent decades worldwide, we are in critical need of more effective diagnostic and therapeutic options. Myriad’s BRACAnalysis® CDx’s FDA approval may be a substantial step forward to better address this tremendous burden on our worldwide healthcare system. Hopefully, it will pave the way toward millions of individuals receiving earlier, more effective treatment to conquer this disease.

Jeremie is an experienced MedTech and healthcare consultant, research scientist, entrepreneur, and clinician-in-training. He is passionate about identifying clinical shortcomings and developing patient-centered solutions through novel therapeutic approaches, healthcare delivery optimization, and translational research innovation.