November 6, 2019 -- Vendor workshops for the upcoming Association for Molecular Pathology (AMP) meeting in Baltimore indicate the direction the industry is going, with new molecular technologies such as mass spectrometry and next-generation sequencing (NGS) replacing traditional ones in some cases.
The organization's annual meeting draws molecular pathologists, pharmaceutical companies, and IVD vendors. Roche, Abbott Diagnostics, Qiagen, Thermo Fisher, Quidel, and Beckman Coulter are among the vendors that will exhibit at the meeting and also run workshops and presentations. Vendor workshops on molecular pathology are described below.
The recent proposed expansion of Medicare coverage in the U.S. for next-generation sequencing should be good news for the industry.
Many vendors will be presenting information on next-generation sequencing at this year's meeting. Qiagen will focus on dealing with the key bottleneck of clinical NGS test interpretation with a seminar about reducing interpretation times by 85%. Twist Bioscience will present a workshop titled "Leading the Way in Target Enrichment." Beckman Coulter will host an event on implementing an automated, comprehensive NGS panel in the community cancer center setting, featuring Dr. Wei-Qi Wei, PhD, an assistant professor in biomedical informatics at Vanderbilt University.
Other workshops on next-generation sequencing include Asuragen's presentation on its NGS-in-a-Box solution for DNA and RNA variants. Arc Bio will focus on NGS-based metagenomics for microlabs, and Bio-Rad will demonstrate orthogonal methods for validation and confirmation of NGS. ArcherDX will demonstrate its panels for characterizing fusions, copy number variations, and other variants in blood cancers. Karius will discuss its Karius test, which the company said can identify microbial cell-free DNA from plasma in patients with severe infection.
Agena Bioscience will showcase its matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF) technology for liquid biopsy and profiling of solid tumors, which it is positioning as a low-cost, high-sensitivity option. The company's MassArray system detects genetic variations directly by label-free mass spectrometry. Its highly sensitive, multiplexed UltraSeek technology on the MassArray system provides a method for detecting rare events -- even low-level genetic determinants can be found, according to the company. This is useful for somatic tumor diagnostics.
The survival motor neuron (SMN) protein is one of a group of proteins called the SMN complex, which is important for the maintenance of specialized nerve cells, or motor neurons. Many mutations in the SMN1 gene have been found to cause spinal muscular atrophy. Asuragen will demonstrate its scalable AmplideX PCR/CE SMN1/2 Plus kit, which the company said offers rapid turnaround time and automated results reporting software.
Each year in the U.S., an estimated 9,000 people get a new diagnosis of chronic myeloid leukemia (CML). CML prevalence is estimated to increase at an annual rate of 4%, and the number of individuals living with this disease is expected to double by 2030. CML is treated with imatinib (Gleevec, Novartis) and other tyrosine kinase inhibitors that target the BCR-ABL fusion protein, and assessing treatment efficacy for CML requires a molecular diagnostic. Asuragen will demonstrate its U.S. Food and Drug Administration-cleared assay for highly sensitive BCR-ABL monitoring, and Cepheid will show its Xpert BCR-ABL Ultra test, which automates the entire test process in one cartridge.
Roche will demonstrate its Avenio circulating tumor DNA (ctDNA) pan-cancer approach. All four mutation classes (single nucleotide variants, indels, fusions, and copy number variations) are incorporated in a single DNA workflow with high sensitivity and specificity. Tissue and ctDNA panels are matched for concordance, and reports are turned around in five days, according to the company. The product may be used across cancers, but it is optimized for lung and colon cancer. Meanwhile, Illumina is highlighting a new oncology menu for its NovaSeq 6000 system, which the company said offers high-throughput testing for liquid biopsy. The sequencing giant is hosting several workshops at the meeting.
Point of care
Point of care (POC) has transitioned to molecular in the past five years. Corporate workshops on this topic include an event hosted by Quidel on POC testing for influenza and Roche's look at centralization and decentralization trends in diagnostic testing.
Carbapenem-resistant Enterobacteriaceae (CRE) or carbapenemase-producing Enterobacteriaceae are resistant to the carbapenem class of antibiotics, which are considered the drugs of last resort for such infections. Meridian Bioscience is hosting a seminar on carbapenem resistance solutions. The company's Revogene Carba C assay provides healthcare systems with a diagnostic solution to enable the early detection and management of CRE.
Bruce Carlson is the publisher of Kalorama Information, part of Science and Medicine Group.
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