SAN FRANCISCO--(BUSINESS WIRE)--Invitae Corporation (NYSE: NVTA), a genetic information company, today announced the expansion of its cardiology offering, including more than 30 cardiovascular test panels for arrhythmias, cardiomyopathies, aortopathies, familial hypercholesterolemia, pulmonary hypertension, and congenital heart disease.
Genetic cardiac conditions may be difficult to diagnose. Often, the first evidence of a hereditary cardiac condition is the sudden death of an otherwise healthy person, sometimes in infancy or childhood. Invitae’s expanded cardiovascular test menu allows the company to provide first-line genetic testing for inherited arrhythmia and cardiomyopathy conditions, including sudden cardiac arrest or death, as well as inherited aortic diseases and familial hypercholesterolemia, one of the most common inherited cardiovascular conditions. This comprehensive cardiology offering includes a rigorous, evidence-based variant classification process developed by a highly qualified team of board-certified genetic counselors, PhD scientists, and physicians with special expertise in the genetic testing for hereditary cardiovascular disorders.
“Heart disease is the number-one cause of death in our country, and there are a number of red flags that could indicate when there’s genetic heart disease in the family,” said Amy Sturm, MS, LCGC, associate professor and genetic counseling expert at The Ohio State University.
Sturm encourages everyone to pay attention to the following types of events in their family health history:
- A relative diagnosed with heart disease at an early age
- Multiple family members who have had a heart attack, an abnormal heart rhythm, heart failure, or a heart transplant
- A relative who died suddenly or had an unexplained death.
With this offering, Invitae’s cardiology menu expands to more than 190 genes, providing fast, affordable, and reliable answers in a flexible format to support overlapping clinical presentations. Clinicians can easily choose the right test for their patient, with no penalty for starting with large or small panels, because of Invitae’s policies of charging a flat price per indication—regardless of the number of genes ordered—as well as allowing physicians to re-requisition additional genes for the same condition within 90 days for no additional charge. Invitae seeks to integrate genetic testing into mainstream cardiology practice. The company’s goal is to provide rapid answers to difficult questions and help patients and their healthcare providers understand the underlying cause of their disease.
According to patient advocacy organization the Sudden Arrhythmia Death Syndromes (SADS) Foundation, making testing more accessible is key. “We believe that with genetic information families can better understand their genetic risks and, when necessary, take preventive action,” the SADS organization stated in their recent newsletter. “Lowering costs of testing and making tests easier to get will help families everywhere. We believe that by working to make these genetic tests more available and affordable we are giving families information that will help save lives.”
“The availability of quality, affordable genetic testing for cardiovascular conditions has the potential to dramatically improve outcomes for patients and their family members who may unknowingly be at higher risk for a cardiac event,” said Robert Nussbaum, MD, chief medical officer of Invitae and an attending physician in the Cardiovascular Genetics Clinic at UCSF. “With this broader and more comprehensive cardiology offering, we now have the tests our patients need in a flexible format and at reasonable cost, making it much easier for clinicians to provide answers for their patients and their patients’ families. Importantly, the results of genetic testing may also help accelerate drug development for genetic cardiovascular conditions in the future.”
Invitae offers a transparent pricing structure independent of the number of genes required to provide an accurate diagnosis for any specific clinical indication. For payers and institutions who are in contract with Invitae, the price per indication can be as low as $950, depending on the payer’s requirements. For third-party payers with whom Invitae is out-of-network and for non-contracted institutions, the price per indication is $1,500. In addition, for patients without third-party insurance coverage or who do not meet insurance criteria for coverage, Invitae offers its full test menu for $475 per indication for patients whose clinician has ordered the testing online and who register online and pay in advance for the testing.
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.
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 belief that the availability of quality, affordable genetic testing has the potential to dramatically improve outcomes for patients and their family members; the belief that the company’s new tests make it much easier for clinicians to provide answers for patients; the belief that genetic testing may help accelerate drug development for genetic cardiac conditions in the future; the potential benefits of genetic testing and the company’s tests; the benefits of the company’s pricing and billing policies; and the ability of the company to realize its goals, including making genetic testing more affordable and accessible to billions of people. 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 ability to generate substantial 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 June 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.