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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

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.

Eutropics and Tolero Pharmaceuticals to Collaborate on Developing a Companion Diagnostic for Experimental Cancer Therapy

Eutropics, Inc , (Cambridge, MA) and Tolero Pharmaceuticals, Inc, (Lehi, UT) recently announced a strategic alliance to utilize Eutropics’ companion diagnostic approach to assist in the development of Tolero’s experimental therapeutics for hematological malignancies. Under the terms of the agreement, Eutropics’ proprietary biomarker platform, Praedicare-Dx, will be used to support the development of Tolero’s therapeutic portfolio, particularly Tolero’s Phase III ready asset, alvocidib. Alvocidib is an experimental therapeutic that has demonstrated clinical activity in patients with acute myelogenous leukemia (AML) and chronic lymphocytic leukemia (CLL). Patient stratification using Eutropics’ companion diagnostics approach will be explored as a way to improve patient care by matching specific therapies to the specific individuals most likely to benefit.

Trovagene, Inc., Grants License for NPM1 Marker to Quest Diagnostics for Acute Myelogenous Leukemia

Trovagene, Inc. (NASDAQ: TROV), a developer of transrenal molecular diagnostics, announced it has granted Quest Diagnostics, the world’s leading provider of diagnostic testing, information and services, a non-exclusive license to incorporate nucleophosmin protein (NPM1) into research and clinical testing services related to acute myelogenous leukemia (AML). Trovagene holds an exclusive worldwide license to US patent 8,222,370 and the corresponding group of U.S. and foreign patent applications around NPM. Terms of the agreement include upfront fees and royalty payments on an annual basis. Additional terms were not disclosed.

China Clears Its First Microarray Platform for in Vitro Diagnostics to Accelerate Personalized Medicine

Affymetrix, Inc. today announced that its GeneChip System 3000Dx v.2 (GCS 3000Dx v.2) has been approved by China’s State Food and Drug Administration (SFDA) for in vitro diagnostic use. The GCS 3000Dx v.2 is the first microarray instrument system to be granted SFDA registration for array-based diagnostics for enabling personalized medicine. China has more than 2,000 clinical centers that will now have access to the only SFDA-cleared microarray platform for clinical testing.

Skyline Diagnostics, Clavis Pharma to Collaborate on Patient Selection Biomarker Discovery for Leukemia Drug Elacytarabine

The Dutch biotech company Skyline Diagnostics B.V. (Skyline) and the Norwegian drug development company Clavis Pharma ASA (Clavis) disclosed signing a research agreement. Under this agreement, Skyline will investigate gene expression biomarkers for selection of individual Acute Myeloid Leukemia (AML) patients that may benefit from a new AML drug in development at Clavis. This drug, elacytarabine, is a novel elaidic acid derivative of cytarabine and currently undergoing the CLAVELA phase III study for treatment of patients with relapsed/refractory AML.