Genection, a subsidiary of Invivoscribe Technologies, has launched MyAML, a CLIA validated next-generation sequencing (NGS) assay for acute myeloid leukaemia (AML).
MyAML is designed to identify clinically actionable, pathogenic and potentially pathogenic mutations in 194 genes associated with AML.
The new assay identifies single nucleotide variants (SNVs), insertion-deletion variants (indels) and the entire range of structural variants, including partial tandem duplications (PTDs) and translocations.
By combining comprehensive gene coverage with improved depth of coverage, long read lengths, and the company's MyInformatics annotation and bioinformatics database, the new assay identifies underlying somatic mutations that are present in as low as 5% allele frequency.
Genection chief medical officer Dr Bradley Patay said: "Acute myeloid leukaemia 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."
The company said the data and report includes single base resolution of the genomic breakpoint and sequences of mutations, which helps minimal residual disease testing and temporal and longitudinal studies.
Dr Patay said: "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.
"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."
MyAML is currently being used by a number of clinical partners and pharmaceutical companies to better define treatment, stratify patients for enrolment in clinical trials, and differentiate AML responder and non-responder populations in retrospective analyses.
The company said MyAML is immediately available through Invivoscribe's accredited laboratories in the US and Europe.