Agena releases MassARRAY 24-Well System for mass spectrometry-based genetic testing

Agena Bioscience today released the MassARRAY 24-Well System for mass spectrometry-based genetic analysis, adding to its existing MassARRAY portfolio. The new 24-well format is tailored to smaller clinical testing laboratories requiring modest sample throughput, reduced initial hardware costs, and reduced time to result.

Agena began developing the new instrument based on the clinical community's feedback shortly after acquiring the MassARRAY platform from Sequenom in 2014. To Peter Dansky, Agena's CEO, it is an early move in the company's drive to ultimately make precision medicine routine and affordable for smaller, regional testing laboratories that may not have access to extensive IT resources and infrastructure to support complex data analysis.

"Labs repeatedly told us if various platforms afforded greater freedom—in terms of test development, accurate results at low cost, and turnaround times—they could be providing more genetic tests to more patients. We're answering those sentiments with a flexible platform that drives down costs to a few dollars to tens of dollars per sample and cuts out big bioinformatics," said Dansky.

"While the research community explores the potential hidden in the human genome, clinicians can utilize validated biomarkers to guide the best outcome for their patients. With our powerful, proven MassARRAY technology, we are working towards enabling clinical laboratories to translate precision medicine into widespread use."

"With the new 24-well system labs can cut wait times and costs for smaller panels or panels that are run less often, such as a lung cancer panel for ALK and other gene mutations. The 24-well scale is also ideal for clinical research studies, which often involve targeted testing of a small cohort of 5 to 50 patients," said Dansky.

The MassARRAY system detects genetic variation directly by label-free mass spectrometry, analyzing up to 50 genetic loci per well. Due to the confidence level that mass spectrometry provides, MassARRAY data are often used to validate variants detected from genome sequencing in the research and clinical settings. The MassARRAY platform's assay design software and services allow clinical laboratories to develop targeted, actionable panels for routine or specialized tests. Genetic testing on a MassARRAY system can cost less than a tenth of the cost of next-generation sequencing tests.

The liquid biopsy field can also exploit the smaller MassARRAY format. Assays specific to an individual can be developed from genome sequencing data within a day and run repeatedly from blood samples at regular intervals, for as little as tens of dollars per test. The latest MassARRAY chemistry, UltraSEEK™, can detect rare variations as low as 0.1% allele frequency, making it one of the most sensitive methods for analyzing cell-free DNA or mutations in circulating tumor cells. UltraSEEK assays can assess up to 10 genetic loci per well, making UltraSEEK the only multiplex methodology for sensitive analysis of liquid biopsies.

Existing 96- or 384-well MassARRAY system users can use the new 24-well format SpectroCHIP^® without any hardware modifications for more economical lower-volume testing and method development.

Labs that purchase the MassARRAY 24-Well System can, as testing volumes expand, upgrade the instrument to support 96- or 384-well formats for increased throughput.

The MassARRAY system is research use only. The U.S. Food and Drug Administration issued in 2014 a premarket clearance for Agena's regulated mass spectrometry-based genotyping instrument, the IMPACT Dx™ System, when used to perform two specific genetic tests as an aid in the diagnosis of patients with suspected thrombophilia.