Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML
(Thomson Reuters ONE) -
SAN DIEGO, April 28, 2017 (GLOBE NEWSWIRE) -- Invivoscribe(®) Technologies Inc.,
a global company with more than 20 years of experience providing clonality and
biomarker test solutions for the fields of oncology, personalized molecular
diagnostics(®) and personalized molecular medicine(®), today announces the
premarket approval of LeukoStrat(®) CDx FLT3 Mutation Assay. Due to current
labeling for the FDA approved test, FLT3 mutation testing with
LeukoStrat(®) CDx FLT3 Mutation Assay is exclusively performed by The Laboratory
for Personalized Molecular Medicine, a subsidiary of Invivoscribe Technologies,
Inc., which has gained FDA approval for its FLT3 test as a companion diagnostic
for the Novartis drug Rydapt® in newly diagnosed FLT3+ AML.
Under terms of a previously announced agreement with Thermo Fisher, Invivoscribe
will also seek FDA approval of the LeukoStrat(®) CDx FLT3 Mutation Assay that
will allow the sale of kits to other laboratories. The Invivoscribe
LeukoStrat(®) CDx FLT3 Mutation Assay is a signal ratio assay that identifies
both internal tandem duplication (ITD) and tyrosine kinase domain (TKD)
mutations, and identifies even large ITD mutations, which are missed using many
current NGS-based assays.
FLT3 somatic variants are among the most common driver mutations with the
strongest effects on the overall survival in acute myeloid leukemia(1) (AML),
the most deadly form of leukemia, which is diagnosed in about 20,000 new
patients each year in the U.S. and has only a 26.6 percent five-year survival
rate(2). Invivoscribe, working under a companion diagnostic agreement with
Novartis, developed this companion diagnostic for FLT3 successfully achieving
FDA regulatory approval. The Invivoscribe LeukoStrat(®) CDx FLT3 Mutation Assay
is the first companion diagnostic for AML.
"This test approval will be of substantial benefit to patients afflicted with
AML and is a critical tool for healthcare providers to identify the most
appropriate treatment for newly diagnosed FLT3-mutated AML patients, furthering
the promise of personalized molecular diagnostics and precision medicine," said
Dr. Jeffrey Miller, CSO & CEO of Invivoscribe. "And, as has been previously
noted by others(3), there is a need for an internationally
standardized FLT3 mutation assay and this companion diagnostic is a step toward
fulfilling that need."
About Invivoscribe
Invivoscribe(®) Technologies Inc. is a privately held biotechnology company
dedicated to improving the quality of healthcare worldwide by providing high
quality, reliable, cutting-edge reagents, tests, and bioinformatics tools to
advance the fields of personalized molecular diagnostics(®) and personalized
molecular medicine(®). Invivoscribe provides ISO 13485 certified, PCR- and NGS-
based reagents manufactured in a facility registered with FDA; RUO test kits;
CE-marked IVDs, including IdentiClone(®) and LymphoTrack(®) Dx Assays with both
LymphoTrack(® )and LymphoTrack(®) Dx Software; for clonality, MRD, and somatic
hypermutation testing. Invivoscribe also offers comprehensive MyAML(®),
MyHeme(®), MyMRD(®), and custom gene panels. Used in combination with
Invivoscribe's proprietary MyInformatics(®) Software these assays identify and
can track primary driver mutations as well as the subclonal architecture and
emergence of new driver mutations in patients with hematologic disease.
Invivoscribe's clinical laboratories in the USA, Europe, and Japan provide
international access to harmonized CLIA, CAP, and ISO 15189 accredited clinical
testing and contract research organization (CRO) services. Invivoscribe's
clinical testing services, tests and reagents are currently being used in more
than 650 clinical and research laboratories in 65 countries. Invivoscribe has
long embraced the value of quality systems and develops all products, including
bioinformatics software, compliant with ISO 13485 design control, making them
eligible to be brought through regulatory process to authorities worldwide.
Additional information can be found at www.invivoscribe.com and www.flt3cdx.com.
References:
1. Papaemmanuil E, Gerstung M, Bullinger L, et al. N Engl J
Med 2016;374(23):2209-2221
2. https://seer.cancer.gov/statfacts/html/amyl.html
3. Levis, M. Hematology Am Soc Hematol Educ Program 2013;2013:220-6
CONTACT:
Kevin Dobyns 858-224-6600
This announcement is distributed by Nasdaq Corporate Solutions on behalf of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Invivoscribe, Inc. via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 28.04.2017 - 19:05 Uhr
Sprache: Deutsch
News-ID 539128
Anzahl Zeichen: 5173
contact information:
Town:
SAN DIEGO, CA
Kategorie:
Business News
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