Kalorama Information, along with representatives from parent company Science and Medicine Group, will be present at the Association for Molecular Pathology (AMP) meeting in Baltimore Maryland. We will be covering the meeting for Lab Pulse.com, Kalorama Information and Instrument Business Outlook.
Seminars of particular interest to Kalorama Information:
Practical Approaches to Centralizing (or Decentralizing) Molecular Testing
CRISPR-CAS: Sessions including “Getting More from your MiSeq with DASH and FLASH” and “Assessing Unintended Off-Target Mutations”
NIPT Requires Greater Oversight and Regulation, According to NDC Report
Picking a LIMS System
- DNA Methylation and Machine Learning in Molecular Pathology for Diagnosis and Clinical Management
- Liquid Biopsy in Infection & Cancer
- The Future of the AMP v. Myriad Decision: Exploring Potential Impacts on Multigene Panel Testing and Patient Care
- Medscape’s Expert Insights into Identifying and Treating TRK Fusion Solid Tumors in Adults and Children
Things we’ll be looking out for at AMP:
Guidelines on Companion Dx: We’ll listen for further discussion and new commentary on the use of evidence-based guidelines for pharmacogenomic tests. Last month, AMP opined that pharmacogenomic tests in clinical practice should be accessible for all healthcare providers, regardless of whether they have training in medical genetics or pharmacogenomics, and that reports should include the interpretation of the findings, significance of the results and limitations of the test. Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA). Tests must have a well-established clinical validity. Read more in LabPulse.com: https://www.labpulse.com/index.aspx?sec=sup&sub=ivd&pag=dis&ItemID=800340.
NGS Sample Prep: Next-generation sequencing sample prep generated $1.8 billion in revenue in 2018 according to a report from Kalorama partner SDI. Sample prep encompasses nucleic acid extraction from biological materials, fragmentation of nucleic acids into smaller pieces and the preparation of sequencing libraries. We expect new product and product modification announcements. Beckman Coulter, Illumina and Fluidigm are among companies in this market. nRichDX will be showcasing its a high-yield sample prep platform called Revolution System in Booth #2655.
Molecular Diagnostic Innovations: Nanostring‘s (booth 2933) nCounter Analysis System offers a cost-effective way to easily profile hundreds of gene transcripts, copy number variations, or miRNAs simultaneously with high sensitivity and precision. The system is comprised of a fully automated prep station, a digital analyzer, the CodeSet (barcodes) and all of the reagents and consumables needed to perform the analysis. The system has been designed to be easy to use and features a step-by-step guide to perform the analysis on a touch screen. The company will provide a technical update on the utility of the Hyb & Seq platform in clinical applications at the meeting, per a recent earnings call. NeuMoDx will display its 96 Molecular System (2859) which the company says is capable of automated extraction and isolation of nucleic acids from multiple specimen types, as well as the automated amplification and detection of target nucleic acid sequences by fluorescence-based PCR. Arc Bio (booth 2951) will demonstrate its assay, the Galileo™ Transplant, which provides a turn-key workflow that enables end-users to easily introduce metagenomic NGS methods into their laboratory. The company says Transplant allows simultaneous detection and quantification of 397 viral strains from a single sample with next day results. Promega (booth #3035) will be providing solutions for use in molecular research, including presentations on past, present and future advances in testing for cancers exhibiting microsatellite instability (MSI) and screening for mismatch repair deficiency in the era of immunotherapy. The company will also present a workshop on the validation of a Novel Diagnostic Test for NASH. Agena Biosciences (booth 3023) will exhibit at the meeting; the company offers both MassARRAY products and services. The company’s products include the MassARRAY System plus ready-made panels that include blood typing panels, cancer panels, cystic fibrosis panel, pharmacogenetic panels, and sample identification and qualification panels, and custom panels. Perkin Elmer will also exhibit; its LabChipGX Touch nucleic acid analyzer provides complete analysis of genomic material in about 30 seconds, which the company says eliminates the nucleic acid quantitation workflow bottleneck.
Illumina workshops and Illumina-Qiagen Deal: The sequencing giant will host several workshops at the meeting, indicative of the company’s strategic direction, including: New Oncology Menu: Enhanced Capabilities to Enable Comprehensive Genomic Profiling; Stakeholders Perspectives on Molecular Medicine: A Panel Discussion; Comprehensive Genomic Profiling Is Becoming a New Standard of Care in Oncology; and Enabling Comprehensive Genomic Profiling from FFPE & Liquid Biopsy Samples on a Single High-Throughput Sequencing Platform. We’ll look out for any additional information on the recent strategic partnership with Qiagen. (Recently, Qiagen and Illumina signed a 15-year strategic partnership on IVD tests that will take advantage of their respective strengths in companion diagnostics and sequencing systems.)
DTC: We’ll be on the lookout for any discussion of policy around direct-to-consumer testing: Earlier in the year AMP urged the FDA to halt its recent crackdown on laboratory developed tests (LDTs) and other pharmacogenomics (PGx) tests that reference specific drugs or drug classes unless approved by the agency.
Awards: Per LabPulse.com (https://www.labpulse.com/index.aspx?sec=sup&sub=gen&pag=dis&ItemID=800383), AMP will honor the following recipients of awards in molecular diagnostics:
- Russell Higuchi, PhD, an R&D fellow at Cepheid, has won the Award for Excellence in Molecular Diagnostics. Higuchi is a molecular biologist who invented the first method and instrument patents for real-time polymerase chain reaction (PCR), the AMP noted in a statement. He also wrote the first papers on ancient DNA and the use of PCR in forensic science. Higuchi is a former executive of Roche Molecular Systems. He is set to deliver a keynote lecture on the use of DNA at the AMP meeting.
- Karl Voelkerding, medical director of genomics and bioinformatics at ARUP Laboratories and professor of pathology at the University of Utah, has won the Jeffrey A. Kant Leadership Award. Voelkerding is being recognized for educational and practical leadership at the AMP. His positions with the organization include past president and program chair of the organization’s Infectious Diseases Subdivision.
- Rami Mahfouz, professor of pathology and laboratory medicine at the American University of Beirut, has won the AMP Meritorious Service Award. Mahfouz was a key driver in the development and launch of the International Affairs Working Group, now called the International Affairs Committee, at the AMP. Mahfouz is being recognized for developing ties with organizations internationally and increasing the number of international attendees at meetings.
To set up an appointment to speak with the Kalorama team at AMP this year, please contact [email protected].