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Biogen and Invitae Announce Availability of Rapid Results in Genetic Testing Program for Spinal Muscular Atrophy (SMA) to Improve Speed of Diagnosis for Patients

799 Days ago

  • New SMA STAT genetic test reduces time to provide results from 21 to four days to aid in clinical care
  • Early treatment of SMA has been shown to slow disease progression and improve or stabilize loss of motor function
  • SMA Identified program offers genetic testing for SMA at no charge to individuals in the U.S.

CAMBRIDGE, Mass. and SAN FRANCISCO, Aug. 20, 2019 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) and Invitae Corporation (NYSE: NVTA) today announced that SMA STAT, a new, rapid-turnaround genetic test for spinal muscular atrophy (SMA), will be offered at no charge to individuals in the U.S. as part of the SMA Identified program. The SMA STAT test reduces the time needed for genetic testing to help confirm a definitive diagnosis of SMA from 21 to four days, enabling individuals and physicians to plan and begin treatment earlier for what is often a life-threatening disease. Clinical studies have demonstrated that early diagnosis and treatment of SMA may prevent the development of severe symptoms, improve motor function and slow the progression of the disease.

A preliminary diagnosis of SMA is typically made through a physician assessment after an individual has developed symptoms, although a diagnosis can also be made through newborn screening. Genetic testing confirms an SMA diagnosis and provides more information that can be used to help guide treatment and care planning decisions. The SMA STAT test detects deletions in the SMN1 gene and assesses copy number of the SMN2 gene, both essential pieces of information for diagnosing and treating SMA. The presence of a greater number of SMN2 copies is generally associated with less severe but still life altering forms of the disease.

“Rapid genetic testing accelerates the diagnostic process. Not only does it minimize the apprehension of waiting, but an even earlier diagnosis promotes earlier intervention and therefore potentially better medical outcomes for patients with SMA. Whether an infant or child is showing early signs of SMA or a long-standing patient requires genetic confirmation of the disease, every day makes a difference,” said Randal Richardson, M.D., neuromuscular neurologist, Gillette Children’s Specialty Healthcare, St. Paul, Minnesota. “This program helps further reduce the barriers to getting a genetic test early in the diagnostic process, enabling a faster transition to the important discussion about how to help patients sooner.”

In 2018 SMA was added to the Recommended Uniform Screening Panel (RUSP), a list of disorders that the U.S. Department of Health and Human Services recommends for states to screen as part of state universal newborn screening programs. Newborn screening for SMA is not currently available in all states. While newborn screening detects the deletion of the SMN1 gene, some states have implemented testing platforms that do not assess the number of SMN2 copies necessitating additional genetic testing. 

The new SMA STAT test expands the SMA Identified program, which launched in April 2018. In addition to the current SMA panel, which provides comprehensive genetic analysis, the SMA Identified program now includes the SMA STAT test and SMA carrier screening, which determines if people are genetic carriers of the disease. The SMA Identified program is open to all individuals within the U.S. with a suspected diagnosis, or family history, of SMA. Testing must be requested by a qualified, U.S.-based healthcare provider.

Healthcare providers seeking more information can visit the SMA Identified website to learn more: https://www.invitae.com/en/sma-identified/.

About SMA1-2
SMA is a rare, genetic, neuromuscular disease that is characterized by loss of motor neurons in the spinal cord and lower brain stem, resulting in severe and progressive muscle atrophy and weakness. About 1 in 10,000 live births have a diagnosis of SMA. Ultimately, individuals with SMA can lose the ability to walk and have difficulty performing the basic functions of life, such as breathing and swallowing, which results in significant healthcare intervention and caregiver assistance. Left untreated, the majority of infants with the most severe form of the disease (SMA Type 1) do not live beyond their second birthday without respiratory intervention. People with childhood or adult onset SMA (Type 2 or 3) produce greater amounts of SMN protein resulting in less severe, but still life-altering forms of the disease. 

About Biogen
At Biogen, our mission is clear: we are pioneers in neuroscience. Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases as well as related therapeutic adjacencies. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Kenneth Murray and Nobel Prize winners Walter Gilbert and Phillip Sharp, and today has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, commercializes biosimilars of advanced biologics and is focused on advancing neuroscience research programs in multiple sclerosis and neuroimmunology, neuromuscular disorders, movement disorders, Alzheimer’s disease and dementia, ophthalmology, immunology, neurocognitive disorders, acute neurology and pain.
We routinely post information that may be important to investors on our website at www.biogen.com. To learn more, please visit www.biogen.com and follow us on social media – Twitter, LinkedIn, Facebook, YouTube.

About Invitae
Invitae Corporation (NYSE: NVTA) is the leading advanced medical genetics company, whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae’s goal is to aggregate the world’s genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company’s website at invitae.com.

Biogen Safe Harbor 
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the identification and treatment of SMA; and the potential benefits and results from early treatment of SMA. These statements may be identified by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would” and other words and terms of similar meaning. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation risks relating to the level of preparedness of healthcare providers to treat patients, risks of unexpected costs or delays; regulatory authorities may require additional information or further studies; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

Invitae Safe Harbor
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the benefits of genetic testing. 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 ability to continue to grow its business; the company’s history of losses; the company’s ability to compete; the company’s failure to manage growth effectively; the company’s need to scale its infrastructure in advance of demand for its tests and to increase demand for its tests; the risk that the company may not obtain or maintain sufficient levels of reimbursement for its tests; the company’s failure to successfully integrate or fully realize the anticipated benefits of acquired businesses; the company’s ability to use rapidly changing genetic data to interpret test results accurately and consistently; security breaches, loss of data and other disruptions; laws and regulations applicable to the company’s business; and the other risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019. These forward-looking statements speak only as of the date hereof, and Invitae Corporation disclaims any obligation to update these forward-looking statements. 

1. Finkel R, Chiriboga C, Vajsar J, et al. Treatment of infantile-onset spinal muscular atrophy with nusinersen: a phase 2, open-label, dose-escalation study. Lancet. 2016;388(10063):3017-3026.

2. Darras B, Markowitz J, Monani U, De Vivo D. Chapter 8 - Spinal Muscular Atrophies. In: Vivo BTD, ed. Neuromuscular Disorders of Infancy, Childhood, and Adolescence (Second Edition). San Diego: Academic Press; 2015:117-145.

David Caouette
+ 617 679 4945
Joe Mara
+1 781 464 2442

Invitae Media Contact:
Laura D’Angelo
+ 628 213 3283

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