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December 07, 2016

Invitae Adds Two Genes, Offers Faster Turnaround Time for Its Breast Cancer STAT Panel

-- Now providing a faster and more comprehensive panel for patients with breast cancer who need rapid test results to guide surgical decisions --

SAN FRANCISCO--(BUSINESS WIRE)-- Invitae Corporation (NYSE:NVTA), a genetic information company, today announced the expansion of its Breast Cancer STAT Panel with the addition of two important breast cancer predisposition genes – ATM and CHEK2 – and a faster turnaround time (TAT) with results available in as few as five days at no additional cost. The announcement was made at the San Antonio Breast Cancer Symposium (SABCS).

“Recent research underscores the clinical utility of ATM and CHEK2 in making treatment decisions, and many of our provider clients have requested these genes be included,” said Robert Nussbaum, MD, chief medical officer of Invitae. “The addition of these genes to Invitae’s Breast Cancer STAT Panel provides clinicians with more comprehensive information without sacrificing time for results, ultimately supporting better patient care for patients and clinicians who need answers to help guide surgical decisions.”

Invitae’s Breast Cancer STAT Panel includes seven well-established genes associated with a significantly increased risk of developing breast cancer: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11, and TP53. Invitae now offers the opportunity to add either or both ATM and CHEK2 based on research showing that each has important implications for understanding risk and guiding treatment decisions. The presence of a variant in any one of these nine genes, or a combination of them, may influence the patient and clinician choice between mastectomy and lumpectomy, whether to perform prophylactic salpingo-oophorectomy, and may inform choice of chemotherapy, including PARP inhibitors.

Results for the expanded Breast Cancer STAT Panel are available in as few as five calendar days (average turnaround is seven). In order to provide clinicians with flexibility, Invitae will also provide testing for BRCA1 and BRCA2 only if desired with the same STAT turnaround time. Invitae also offers the ability to re-requisition additional cancer genes within 90 days at no additional charge.

"When I ask most of my newly diagnosed breast cancer patients when they want surgery, their most frequent response is 'yesterday,'" said Barry Rosen, MD, breast cancer surgeon at Advocate Health in Barrington, Illinois. “Prior to Invitae's STAT testing, my patients were faced with the difficult choice to wait as long as a month for the testing to return before proceeding with surgery, or, more commonly, making a decision based on chance rather than science. Having a one week turnaround has dramatically improved my ability to care for my patients."

Invitae’s Breast Cancer STAT Panel has the same high quality as Invitae’s current validated, hereditary cancer tests. Data published in the Journal of Molecular Diagnostics demonstrated the analytical accuracy (100%) and clinical concordance (99.8% compared to results from Myriad Genetics) of Invitae’s methods in a study of more than 1,000 patients in collaboration with Massachusetts General Hospital and the Stanford University School of Medicine. In addition, data showing the clinical utility of the Invitae hereditary breast and ovarian cancer (HBOC) panel test was published in a companion manuscript in JAMA Oncology.

The additional genes are available at no additional charge and testing is available for both blood and saliva samples. The company recently announced agreements with the top five largest insurers in the United States, providing greater access for patients than ever before. Invitae’s transparent and affordable patient-pay option of $475 will continue to be available. As a matter of policy, Invitae does not hold samples or findings reports while managing insurance claims.

“It is now so easy to just schedule my patients’ surgeries only one to two weeks into the future knowing full well that the Invitae STAT test will have returned results before the procedure to confirm which is the best surgical option,” said Paul Baron, MD, FACS, Breast and Melanoma Specialists of Charleston. “It has totally changed how I manage newly diagnosed patients.”

Clinicians are able to access Invitae’s Clinical Consult Service through the entire testing process to select the right test, clarify results, and review individual patient cases at no additional charge. Invitae also makes telephone genetic counseling services available to patients before and after testing by clinician request.

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 STAT panel influencing surgical decisions and treatment options and supporting better patient care. 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

NYSE: NVTA 8.55 +0.22 +2.64% Volume: 380,108 20 minute delay December 15, 2017

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