Invitae Announces It Met Volume Guidance By Delivering Nearly 19,000 Billable Tests In 2015 And Sets Volume Guidance At 50,000-70,000 Billable Tests For 2016

-- Demonstrated scalability of business with more than 400% year-over-year growth --

-- Planning to expand menu to more than 3,000 genes by the end of 2016 --

-- Management to present at the 33rd Annual JP Morgan Healthcare Conference --

SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE: NVTA), a genetic information company, today announced that it met its volume guidance of 17,000-19,000 billable tests delivered in 2015, delivering nearly 19,000 billable tests for the year, representing a greater than 400% increase from the more than 3,600 billable tests delivered in 2014. Invitae reported that it accessioned more than 20,000 samples in 2015.

“We look forward to strong growth in 2016 as we continue to provide high quality, affordable genetic testing options to the millions of individuals suffering from genetic disorders.”

In the fourth quarter of 2015, Invitae delivered nearly 7,000 billable tests, representing a 36% increase over the third quarter of 2015, and accessioned nearly 8,000 samples. Invitae will report its financial results and other metrics during its fourth quarter and year-end 2015 conference call in February.

Additionally, the company announced guidance for 2016, including plans to:

• reduce the cost of goods sold (COGS) to under $500 per report in 2016;
• expand test menu to include more than 3,000 genes by the end of 2016;
• deliver between 50,000-70,000 billable tests;
• secure reimbursement for Medicare patients by the Centers for Medicare and Medicaid Services (CMS) and from top private payers;
• generate revenues exceeding the cost of revenue by the fourth quarter of 2016; and
• pilot its first programs in genome management with the launch of an adult prevention panel intended for healthy adults who wish to learn more about their risk for common, actionable genetic conditions.

“2015 was a foundational year for Invitae as we demonstrated our ability to scale our genetic testing business by meeting or exceeding our key metrics: we made significant reductions in our cost of goods, increased content almost three fold, grew volume by more than 400% year over year, and published key clinical validation and clinical utility studies that we believe will lead to significant progress in reimbursement over the course of 2016,” said Randy Scott, chairman & CEO of Invitae. “We look forward to strong growth in 2016 as we continue to provide high quality, affordable genetic testing options to the millions of individuals suffering from genetic disorders.”

Invitae will be presenting at the 2016 JP Morgan Healthcare Conference on Wednesday, January 13, 2016, at 10:00 a.m. Pacific. A live, listen-only webcast of the presentation and Q&A session can be accessed by visiting the events section of Invitae’s website at ir.invitae.com.

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 single 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 ir.invitae.com and follow us on Twitter: @invitae and @invitaeIR.

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 the company’s expectations regarding its plans for 2016, including revenue levels, the cost of goods sold, the number of billable tests delivered, the number of genes in its test menu, and the nature and extent of future reimbursement coverage; the company’s expectations regarding continued growth in 2016; and the timing of any new testing service releases and the benefits and attributes of any such services. 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: 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; risks associated with the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; the company’s ability to compete; laws and regulations applicable to the company’s business, including 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, 2015. 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.