PR84006

Invivoscribe Submits LeukoStrat(R) CDx FLT3 Mutation Assay to NMPA in China and Expands Company, Adding Laboratory in Shanghai to Provide Comprehensive Support for Partners

SAN DIEGO, May 12, 2020 /PRNewswire=KYODO JBN/ --

Invivoscribe is pleased to announce that their LeukoStrat(R) CDx FLT3 Mutation

Assay (

https://c212.net/c/link/?t=0&l=en&o=2801117-1&h=651919305&u=https%3A%2F%2Finvivoscribe.com%2Fclinical-services%2Fleukostrat-cdx-flt3-mutation-assay&a=LeukoStrat%C2%AE+CDx+FLT3+Mutation+Assay

)was submitted to regulatory authorities in China in April in support of the

Astellas New Drug Application (NDA) submission of XOSPATA(R) (gilteritinib) for

treatment of adult patients who have relapsed or refractory acute myeloid

leukemia (AML) with a FLT3 mutation. Invivoscribe also announced expansion of

its wholly-owned company, Invivoscribe Diagnostic Technologies (Shanghai) Co.

Ltd., adding laboratory testing services to support clinical trials and

pharmaceutical partners.

Logo - https://mma.prnewswire.com/media/1019746/Invivoscribe_Logo.jpg

Invivoscribe developed the LeukoStrat CDx FLT3 Mutation Assay in partnership

with Astellas as the companion diagnostic supporting use of gilteritinib to

treat adult patients with relapsed/ refractory FLT3-mutated AML.

"This is an announcement of two significant milestones: Submission of our

LeukoStrat CDx Assay to the NMPA, and the expansion of our laboratory network

into China. The submission itself is a milestone that builds on the

LeukoStrat(R) CDx FLT3 Mutation Assay as the international gold standard signal

ratio assay for comprehensive assessment of activating mutations in the FLT3

gene; one of the most important biomarkers in AML", said Jeffrey Miller,

Invivoscribe's CSO and CEO. "Further, the expansion of our company to include a

laboratory was done to provide comprehensive test support for our partners

conducting trials in China. Testing will include simultaneous assessment of

minimal residual disease by both flow cytometry and next-generation sequencing

technologies conducted on exactly the same subject specimen. These paired

analyses have been requested by regulatory authorities and partners, but have

been missing in clinical studies. Invivoscribe's LabPMM laboratories will bring

this long-desired capability to fruition in our laboratories in China, Japan,

Europe, and the US."

The LeukoStrat CDx FLT3 Mutation Assay is the only internationally standardized

signal ratio assay that identifies both ITD and TKD mutations of the FLT3

biomarker. It has been approved as a companion diagnostic by regulatory

authorities in the US, Australia, and Japan, and is available as a CE-marked

kit in Europe and Switzerland. The LeukoStrat(R) CDx FLT3 Mutation Assay served

as the companion diagnostic in the ADMIRAL, RATIFY and QuANTUM-R clinical

trials, which supported approvals of gilteritinib (XOSPATA(R)), midostaurin

(RYDAPT(R)) and quizartinib (VANFLYTA(R)). The assay is available both as a

service and as a kit. LeukoStrat CDx FLT3 Mutation Assay test services are

available from LabPMM locations in Japan, Germany, and the United States.

About Invivoscribe

Invivoscribe has focused on Improving Lives with Precision Diagnostics(R) for

more than twenty-five years, advancing the field of precision medicine by

developing and selling standardized reagents, tests, and bioinformatics tools

to more than 700 customers in 160 countries. Invivoscribe also has a

significant impact on global health working with pharmaceutical companies to

accelerate approvals of new drugs and treatments by supporting international

clinical trials, developing, commercializing companion diagnostics, and

providing expertise in both regulatory and laboratory services. With its proven

ability to provide global access to distributable reagents, kits, and controls,

as well as clinical trial services through our international clinical lab

subsidiaries (LabPMM), Invivoscribe has demonstrated it is an ideal partner.

For additional information please contact Invivoscribe at:

customerservice@invivoscribe.com or visit: www.invivoscribe.com.

Source - Invivoscribe, Inc.