No-charge gBRCA testing for patients diagnosed with HER2-negative locally advanced or metastatic breast cancer 

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Pfizer has partnered with Invitae to offer the BRCA Care genetic testing program, which provides sponsored, no-charge germline BRCA (gBRCA) testing for patients diagnosed with HER2-negative locally advanced or metastatic breast cancer (HER2- LA/mBC).

WHY BRCA MATTERS IN BREAST CANCER

BRCA1 and BRCA2 are genes that produce proteins involved in DNA repair. When either of these genes is altered or mutated, DNA repair may not progress correctly. This can lead to the development of certain types of cancer. BRCA mutations can be hereditary (germline) or occur spontaneously (sporadic).1,2

People with DNA repair deficiencies such as a germline BRCA mutation are significantly more likely to develop early onset of breast cancer and have a high risk to have recurrence in the contralateral breast at a later stage.

gBRCA mutations account for:

●    ~3-6% of all Breast Cancers4-6

●    ~4-16% of Male Breast Cancers7

●    ~25% of Hereditary Breast Cancers8,9

In addition to the informing treatment decisions in patients with HER2- LA/mBC, knowing the status of the BRCA1 and BRCA2  genes may allow patients to inform family members of their potential risk.

NCCN Clinical Practice Guidelines In Oncology (NCCN Guidelines®):

In the metastatic setting, results from genetic testing may have therapeutic implications. Germline mutations in BRCA1 and BRCA2 have proven clinical utility and therapeutic impact.

Therefore, germline BRCA1 and BRCA2 should be assessed in all patients with recurrent or metastatic breast cancer to identify candidates for poly adenosine diphosphate ribose polymerase (PARP)-inhibitor therapy.10

Program eligibility

The BRCA Care genetic testing program sponsored by Pfizer is available to patients with HER2-negative locally advanced or metastatic breast cancer (HER2- LA/mBC) in the following countries:

  • Chile

  • Hong Kong

  • Lebanon

  • Oman

  • Qatar

  • Saudi Arabia

  • Singapore

  • Taiwan

  • United Arab Emirates

Region-specific ordering instructions:


 

Asia Pacific (Hong Kong, Singapore, Taiwan) 
To order test kits please email apac@invitae.com and reference the BRCA Care program in the email.

Latin America (Chile)
To order test kits please email chile@invitae.com and reference the BRCA Care program in the email.

Middle East (Lebanon, Oman, Qatar, Saudi Arabia, United Arab Emirates)
To order test kits please visit www.invitae.com/request-a-kit or email emea@invitae.com and reference the BRCA Care program in the email.

Initial program panel

The BRCA Care program offers testing with the Invitae BRCA1 and BRCA2 STAT Panel, which analyzes the BRCA1 and BRCA2 genes.

Once Invitae receives your patient’s blood or saliva specimen, their results will be available in 5 to 12 calendar days (7 days on average). Accelerated turnaround time may be necessary because physicians and patients often want to make management decisions as quickly as possible.

Re-requisition panel

The BRCA Care program offers clinicians the ability to receive subsequent analysis by re-requisition to a larger cancer panel. For example, the Invitae Multi-Cancer Panel which includes 84 genes associated with hereditary cancers across major organ systems.

This subsequent analysis is offered at no additional charge if ordered within 90 days of the original report release. No new sample is required.

Support every step of the way

Clinical Consult Services

Invitae’s team of board-certified and experienced genetic counselors trained in medical genetics is available to assist clinicians. Clinicians can reach our genetic counselors by calling +1 (415) 930-4018 , Monday through Friday, 5:00 am to 5:00 pm Pacific Time.

Contact

Family follow-up testing

Invitae will also offer family variant testing (FVT) for all blood relatives of patients found to have a pathogenic or likely pathogenic variant, at no additional charge within 90 days of the original patient’s test. Our family variant testing reports on the presence or absence of the familial variant(s) as well as any clinically informative variants in the full gene.

About Invitae

Invitae is a genetic information company whose mission is to bring genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Specializing in genetic diagnostics for hereditary disorders, Invitae is aggregating the world’s genetic tests into a single service with better quality, faster turnaround time, and a lower price than most single-gene tests today.

About Pfizer, Inc.

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

While Pfizer may provide financial support for this program, tests and services are performed by Invitae. Healthcare professionals must confirm that patients meet certain criteria to use the program. Pfizer may receive de-identified patient data from this program, but at no time would they receive patient identifiable information. Pfizer may receive contact information for healthcare professionals who use this program. Healthcare professionals and patients who participate in this program have no obligation to recommend, purchase, order, prescribe, promote, administer, use or support any other products or services from Invitae or from Pfizer.

References:

  1. National Institutes of Health. National Cancer Institute. BRCA mutations: cancer risk and genetic testing. What are BRCA1 and BRCA2? National Institutes of Health Web site. https://www.cancer.gov/about-cancer/causes-prevention/genetics/brca-fact-sheet#q5. Accessed May 10, 2018. 
  2. Levin B, Lech D, Friedenson B. Evidence that BRCA1- or BRCA2-associated cancers are not inevitable. Mol Med. 2012;18(1)1327-1337. 
  3. Meynard G, Villanueva C, Thiery-Vuillemin A, et al. 284P—Real-life study of BRCA genetic screening in metastatic breast cancer. Ann Oncol. 2017;28(suppl 5):v74-v108. 
  4. Fasching PA, Hu C, Hart SN, et al. Cancer predisposition genes in metastatic breast cancer—association with metastatic pattern, prognosis, patient and tumor characteristics. Paper presented at 40th Annual San Antonio Breast Cancer Symposium; December 5-9, 2017; San Antonio, TX. Abstract PD1-02.  
  5. Nelson HD, Fu R, Goddard K, et al. Risk Assessment, Genetic Counseling, and Genetic Testing for BRCA-Related Cancer: Systematic Review To Update the U.S. Preventive Services Task Force Recommendation. Rockville, MD: Agency for Healthcare Research and Quality; December 2013. Evidence Synthesis, No. 101; AHRQ publication 12-05164-EF-1. 
  6. Tung N, Lin NU, Kidd J, et al. Frequency of germline mutations in 25 cancer susceptibility genes in a sequential series of patients with breast cancer. J Clin Oncol. 2016;34(13):1460-1468. 
  7. Giordano SH. Breast cancer in men. N Engl J Med. 2018;378(24):2311-2320. 
  8. Arpino G, Pensabene M, Condello C, et al. Tumor characteristics and prognosis in familial breast cancer. BMC Cancer. 2016;16(1):924. 
  9. Kleibl Z, Kristensen VN. Women at high risk of breast cancer: molecular characteristics, clinical presentation and management. Breast. 2016;28:136-144. 
  10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Breast Cancer V.5.2020. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed March 6, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.