SAN DIEGO, CA--(Marketwired - Mar 17, 2015) - Genection™, Inc., a subsidiary of Invivoscribe Technologies®, Inc., announced today that it has launched MyAML™, a CLIA validated next generation sequencing assay which identifies clinically actionable, pathogenic, and potentially pathogenic mutations in 194 genes associated with acute myeloid leukemia (AML).
"Acute myeloid leukemia afflicts tens of thousands of patients worldwide annually. MyAML™ reveals both the predominant driver mutations and the subclonal architecture of genomic mutations that recur in AML, providing clinicians with the best prognostic tool to stratify patients and direct patient care, expand and better define therapeutic options, and identify the appropriate clinical trials for their patients. Precision medicine is a reality today," said Genection's Chief Medical Officer, Bradley Patay, MD.
The MyAML™ panel identifies single nucleotide variants (SNVs), insertion-deletion variants (indels) and the entire range of structural variants, including partial tandem duplications (PTDs) and translocations -- even those involving novel fusion gene partners. Coupling comprehensive gene coverage with enhanced depth of coverage, long read lengths, and the power of Genection's proprietary MyInformatics™ annotation and bioinformatics database, MyAML™ identifies the underlying somatic mutations that are present in as low as 5% allelic frequency. The data and report includes single base resolution of the genomic breakpoint and sequences of mutations, which facilitates both minimal residual disease testing and temporal and longitudinal studies.
"The MyAML™ test generates such a rich compendium of data that it may provide the long-sought-after crucial link between the clonal architecture of AML somatic mutations, treatment regimens, and patient outcomes," Dr. Patay continued. "Further, MyAML™ was developed under full design control within Invivoscribe's ISO 13485 certified quality system. Following this process allows us to take this panel through regulatory approval as a companion diagnostic for multiple therapeutic drug partners."
Since MyAML™ was designed to be a comprehensive test performed within clinically relevant turnaround times, clinicians can make timely decisions for individual AML patients using one molecular test. The test results, including variants recommended in the NCCN guidelines, are provided in an easy to understand report.
"The Release of the MyAML™ panel is just the latest example of our commitment to develop tests that enable clinicians to tailor treatment for each patient", said Invivoscribe's COO, Timothy Stenzel, MD, PhD. "The promise of personalized molecular medicine® is to ensure every patient receives optimal care."
MyAML™ is currently being used by a number of clinical partners and pharmaceutical companies to better define treatment, stratify patients for enrollment in clinical trials, and differentiate AML responder and non-responder populations in retrospective analyses. The test is immediately available through Invivoscribe's accredited laboratories in the United States and Europe.
About Invivoscribe Technologies, Inc.
Invivoscribe and its affiliated companies (Genection, Inc. and the LabPMM laboratories) are the world's leading providers of molecular diagnostic testing solutions for leukemias and lymphomas. All products are manufactured in our ISO 13485 accredited GMP manufacturing facility. Our internationally harmonized and validated tests are used by pharmaceutical and biotechnology companies, cancer researchers, academic hospital testing centers, and reference laboratories worldwide to identify, stratify and monitor hematologic cancers. These include next generation sequencing LymphoTrack® assays for both Illumina and Thermo-Fisher NGS platforms, CE-marked IdentiClone® assays and PCR-based assays and controls for gene rearrangement, chromosome translocation, and gene mutation testing on capillary electrophoresis and gel based systems. Our companion diagnostic program assists pharmaceutical companies in the development of therapeutic agents and devices. Exclusive patent rights cover the majority of our gene rearrangement and gene mutation testing products.
For more information or to order MyAML, please visit http://www.genection.com/myaml.html
Invivoscribe Technologies, Inc.
Vice President, Global Commercial Operations