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December 14, 2016

Invitae Sees Increase in Utilization of Its Inherited Prostate Cancer Genetic Tests

-- High quality, comprehensive, affordable genetic tests designed to ensure access for prostate cancer patients who may benefit from broader panel testing, including BRCA1, BRCA2, and other genes associated with prostate cancer --

SAN FRANCISCO--(BUSINESS WIRE)-- Invitae Corporation (NYSE:NVTA), one of the fastest growing genetic information companies, has seen a significant increase in genetic testing for prostate cancer since the publication of landmark data showing testing may be underutilized when screening for and treating the second most common cancer in men. The company’s panel is the most comprehensive and affordable genetic test available to urologists and oncologists who treat men with prostate cancer, establishing the company as a new leader in prostate cancer testing.

According to a study in the New England Journal of Medicine (NEJM), the incidence of germline mutations in men with metastatic prostate cancer is over 11% – higher than the historical rate for BRCA1 and BRCA2 mutations in high-risk breast cancer patients. Additionally, the study suggests that family history alone may be insufficient for gauging risk of prostate cancer and making treatment decisions. The study showed mutations in multiple DNA repair genes, including BRCA1, BRCA2, ATM, CHEK2, RAD51D, and PALB2, are significantly increased in metastatic prostate cancer patients. Related findings further support offering all men with metastatic prostate cancer germline genetic testing.

“I believe the NEJM study showing inherited DNA-repair gene defects are more common in prostate cancer patients than expected is among the most important data published this year,” said Oliver Sartor, MD, Laborde Professor of Cancer Research, Tulane Cancer Center in New Orleans. “The results add to the growing body of evidence regarding hereditary mutations associated with prostate cancer and confirm and extend the importance of the germline mutations. My research showed at least 1 in 8 men meeting recommended criteria for BRCA testing carried an identifiable and actionable germline mutation. Just as we see in inherited breast cancer, analyzing only BRCA1 or BRCA2 would fail to identify more than 50 percent of men with relevant germline mutations."

Invitae has more experience with hereditary cancer testing in prostate cancer than most other laboratories due to its broad, comprehensive menu and flexible ordering approach. The Invitae Prostate Cancer Panel analyzes up to 14 genes that are associated with a hereditary predisposition to prostate cancer. This panel may be considered for individuals with prostate cancer, especially early onset, aggressive or metastatic tumors. Other candidates for testing include patients whose history is suggestive of a hereditary cancer syndrome, such as a personal and/or family history of:

  • prostate cancer with a Gleason score ≥7
  • prostate, breast, ovarian, uterine, colon, pancreatic, melanoma, or sarcoma, particularly if early onset (<50 years)
  • male breast cancer
  • Ashkenazi Jewish ancestry and prostate, pancreatic, breast, or ovarian cancer

Research published in the Journal of Clinical Oncology has shown BRCA1 and BRCA2 mutations are both known to increase the lifetime risk of prostate cancer by about 20%. HOXB13 mutations are associated with an up to 60% lifetime risk of prostate cancer, according to another study. In addition, African American men with prostate cancer may be more likely to have germline mutations in the BRCA1 and BRCA2 genes than Caucasian men with prostate cancer, as presented during the 111th Annual Scientific Meeting of the American Urological Association this year. According to the American Cancer Society, nearly three million men have been diagnosed with prostate cancer in the United States.

“We are now beginning to truly understand how mutations in the BRCA genes could impact a man’s risk of developing prostate cancer and aggressive disease, just as we do with breast cancer in women,” said Brian Helfand, MD, PhD, clinical associate professor at the University of Chicago and a clinician at NorthShore University HealthSystem in Chicago. “Invitae’s testing provides us with information on clinically significant genes, allowing clinicians to use the information to identify men with prostate cancer at earlier stages and provide personalized therapies to those with potentially lethal disease.”

Rapid results and genetic counseling support available for clinicians and patients

Invitae provides results in as few as 10 calendar days (14 days on average). To help support clinicians and their patients, Invitae offers its clinicians access to its Clinical Consult Service, where Invitae’s expert team of medical geneticists and genetic counselors provide support through the entire testing process to select the right test, clarify results, and review individual patient cases at no additional charge. Invitae also makes genetic counseling services available as needed.

“Use of Invitae’s prostate cancer panels increased throughout the year, and the trend intensified with the publication of data confirming the role of gene mutations in patients with aggressive prostate cancer. It’s clear the prostate cancer community is responding to research showing the value of genetic information that has long benefitted the breast and ovarian cancer communities,” said Robert Nussbaum, MD, chief medical officer of Invitae.

“Invitae has gained extensive experience in hereditary prostate cancer throughout 2016, which ultimately positions us as the strongest partner for clinicians who treat prostate cancer, as well as the biopharma companies pursuing targeted therapeutic approaches,” said Sean George, PhD, president and chief operating officer of Invitae.

Invitae is a Medicare provider, and is in contract with major national and regional commercial payers. The company is committed to driving down the cost of genetic testing with simple and transparent pricing, including a $475 up-front, patient-pay price for any test within a single clinical area.

About Invitae

Invitae Corporation's (NYSE: NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. Invitae’s goal is to aggregate most of the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower price than many single-gene and panel tests today. The company currently provides a diagnostic service comprising hundreds of genes for a variety of genetic disorders associated with oncology, cardiology, neurology, pediatrics, and other rare disease areas. For more information, visit our website at invitae.com.

Safe Harbor Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to Invitae’s panel establishing the company as a new leader in prostate cancer testing; that genetic testing will allow clinicians to identify men with prostate cancer at earlier stages and provide personalized therapies; that the prostate cancer community is responding to research showing the value of genetic information; and Invitae being positioned as the strongest partner for clinicians who treat prostate cancer, as well as biopharma companies pursuing targeted therapeutic approaches. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately, consistently, and quickly; the company’s history of losses; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the company’s ability to develop and commercialize new tests and expand into new markets; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; laws and regulations applicable to the company’s business, including state licensing requirements and potential regulation by the Food and Drug Administration; and the other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements.

NOTE: Invitae and the Invitae logo are trademarks of Invitae Corporation. All other trademarks and service marks are the property of their respective owners.

Source: Invitae Corporation

Source: Invitae Corporation

Invitae Corporation

Laura D’Angelo, 314-920-0617

pr@invitae.com

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