SAN FRANCISCO, Oct. 29, 2018 /PRNewswire/ -- Invitae
Corporation (NYSE: NVTA), one of the fastest growing genetics
companies, announced today it has expanded its partnership with
Alnylam Pharmaceuticals, the leading RNAi therapeutics company, to
provide genetic testing at no cost to patients through the
Alnylam Act® program for individuals who may
carry gene mutations associated with primary hyperoxaluria, an
ultra-rare genetic disorder affecting the kidneys that most often
presents in childhood.
The Alnylam Act® program was developed to
reduce barriers to genetic testing and counseling in order to help
people make informed decisions about their health. As part of the
Alnylam Act® program, patients in the U.S. and
Canada with a suspected diagnosis
or a confirmed family history of primary hyperoxaluria may be
eligible to receive Invitae genetic testing at no charge. Invitae
will provide results to participating clinicians and their patients
in as little as two weeks. Alnylam provides funding to support the
program.
"Increasing access to genetic testing can shorten the path to
diagnosis and prevent misdiagnoses for patients with suspected
primary hyperoxaluria, which is essential given its early onset and
the potential for it to progress to life-threatening end-stage
renal disease," said Pritesh J.
Gandhi, PharmD., Vice President and General Manager,
Lumasiran program at Alnylam. "We are very pleased to be working
with Invitae on this important program to make genetic testing
available to patients sooner in the diagnostic process."
In extreme cases of primary hyperoxaluria type 1 (PH1), kidney
damage can be present in patients as young as four months old and
as many as a third of PH1 patients are not diagnosed until they
have reached end-stage renal failure. Genetic testing for primary
hyperoxaluria determines whether a patient is a carrier of a
mutation in the gene (AGXT) associated with the disease to confirm
a diagnosis and inform clinical decision-making.
"Particularly for rare progressive diseases such as PH1, early
and accurate diagnosis is essential when making choices for
managing the disease. We strongly believe that genetic testing has
the ability to accelerate the diagnostic process, and an early
diagnosis has the power to change medical outcomes," said
Robert Nussbaum, MD, chief medical
officer of Invitae. "Invitae is proud to partner with Alnylam to
provide genetic testing to these patients to support their ability
to make informed medical decisions for themselves and their
families."
Primary hyperoxaluria is an inherited disorder of glyoxylate
metabolism in which hepatic enzyme deficiencies result in excessive
endogenous production of oxalate. The excess oxalate cannot be
degraded and is excreted in large amounts by the kidneys, resulting
in high urinary concentrations. Most patients with primary
hyperoxaluria type 1 present with signs or symptoms related to
kidney stones; symptoms are observed in 65 percent of patients
before age 101 and 85 percent of patients before age
202. Over time, progressive renal damage leads to
impaired kidney function. In extreme cases, compromised kidney
function can be evident early on during infancy.
Invitae-sponsored testing programs help lower barriers to
obtaining diagnostic genetic information for patients and
clinicians. Sponsors provide financial support for these programs,
which offer specified genetic testing at no cost to patients.
Invitae and sponsor companies collaborate on informing clinicians
about the programs. Participation is based on eligibility criteria
set for each program and testing must be ordered by a clinician.
Patient privacy is strictly protected and program sponsors do not
have access to identifiable patient information.
Patients and clinicians who are interested in Alnylam
Act® can learn more at the program website at
www.invitae.com/alnylam-act-hyperoxaluria-type1.
About Invitae
Invitae Corporation (NYSE: NVTA) is a
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 most of the
world's genetic tests into a single service with higher quality,
faster turnaround time and lower prices.
About Alnylam Pharmaceuticals
Alnylam (Nasdaq: ALNY)
is leading the translation of RNA interference (RNAi) into a whole
new class of innovative medicines with the potential to transform
the lives of people afflicted with rare genetic, cardio-metabolic,
hepatic infectious, and central nervous system (CNS) diseases.
Based on Nobel Prize-winning science, RNAi therapeutics represent a
powerful, clinically validated approach for the treatment of a wide
range of severe and debilitating diseases. Founded in 2002, Alnylam
is delivering on a bold vision to turn scientific possibility into
reality, with a robust discovery platform. Alnylam's first U.S.
FDA-approved RNAi therapeutic is ONPATTRO™ (patisiran) lipid
complex injection available in the U.S. for the treatment of the
polyneuropathy of hereditary transthyretin-mediated (hATTR)
amyloidosis in adults. In the EU, ONPATTRO is approved for the
treatment of hATTR amyloidosis in adults with stage 1 or stage 2
polyneuropathy. Alnylam has a deep pipeline of investigational
medicines, including four product candidates that are in late-stage
development. Looking forward, Alnylam will continue to execute on
its "Alnylam 2020" strategy of building a multiproduct,
commercial-stage biopharmaceutical company with a sustainable
pipeline of RNAi-based medicines to address the needs of patients
who have limited or inadequate treatment options. Alnylam employs
over 800 people worldwide and is headquartered in Cambridge, MA. For more information about our
people, science and pipeline, please visit www.alnylam.com and
engage with us on Twitter at @Alnylam or on LinkedIn.
Invitae's Safe Harbor Statement
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 Invitae's partnership with
Alnylam to provide genetic testing through the Alnylam Act program,
including the ability to shorten the path to diagnosis, aid in the
diagnosis of patients, support the ability of patients and their
physicians to make informed medical decisions, and potentially
change medical outcomes. 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: Invitae's ability to use rapidly
changing genetic data to interpret test results accurately and
consistently; laws and regulations applicable to Invitae's
business; Invitae's failure to manage growth effectively; Invitae's
ability to compete; security breaches, loss of data and other
disruptions; and the other risks set forth in Invitae's filings
with the Securities and Exchange Commission, including the risks
set forth in its Quarterly Report on Form 10-Q for the quarter
ended June 30, 2018. These
forward-looking statements speak only as of the date hereof, and
Invitae Corporation disclaims any obligation to update these
forward-looking statements.
Contact:
Laura D'Angelo
pr@invitae.com
(628) 213-3283
1 Edvardsson VO, Goldfarb DS, Lieske JC, Beara-Lasic
L, Anglani F, Milliner DS and Palsson F. Hereditary causes of
kidney stones and chronic kidney disease, Pediatr Nephrol. 2013,
28:1923-42.
2 Hoppe, Bernd, Bodo B.
Beck, and Dawn Milliner. "The
Primary Hyperoxalurias." Kidney international 75.12 (2009):
1264–1271. PMC. Web. 23 July
2018.
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