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 BiogenAt 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 HarborThis 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.
Reference: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.
MEDIA CONTACT: |
INVESTOR CONTACT: |
Biogen |
|
David Caouette+ 617 679
4945public.affairs@biogen.com |
Joe Mara+1 781 464
2442IR@biogen.com |
Invitae Media Contact:Laura D’Angelo+ 628 213
3283pr@invitae.com
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