As we close out 2019, we reflect on how grateful we are to be a part of such an impactful industry. Exhibiting at the 25^th anniversary AMP conference last month really drove this point home.  The exhibit hall hummed with an undertone of precision diagnostics, as companies continue to focus on developing products that will ultimately drive more tailored treatments for patients.  The most prevalent theme remained Oncology, though microbiology solutions and expanding NGS applications have also gained significant traction. 

 Included below are a few of the state-of-the-art precision diagnostics technologies that got our attention at AMP in Baltimore this year:

Company: Agena Bioscience

Product: The MassARRAY® System

What it is:   A non-fluorescent detection platform utilizing mass spectrometry to accurately measure PCR-derived amplicons, with applications for genotyping and mutation detection, ultrasensitive detection, and methylation analysis.

Why it’s Cool:  Using Mass Spec analysis for targeted SNP Genotyping panels is highly precise and specific, allowing for multiplexing of target panels across various channels concurrently.  While mass spec has historically been a labor-intensive technology, the MassARRAY system requires only 28 minutes of hands on time and allows for same day results (8.8 hours elapsed time).

 

Company: Agilent Technologies

Product: “Stain to Sequencing” solution featuring the new Magnis automated library preparation system

What it is: Agilent is now able to provide a comprehensive suite of products for the entire tissue journey from staining through sequencing with the following:

1. 4150 TapeStation System for sample QC Magnis for automated NGS library prep.
2. Sure Select system for target enrichment Sequencing (Illumina).  Alissa Interpret for automated variant triage, classification, curation, and annotation.

Why it’s cool: The all-in-one workflow is based on NCCN guidelines and allows for lower CVs, as well as financial and service benefits compared to alternative workflows. Through a partnership with Illumina, Agilent is able to fill a current portfolio gap in sequencing to be able to offer this full suite of products under a single umbrella.  The TapeStation System allows for quality control of the sample throughout the workflow.

 

Company: NeuMoDx

Product: NeuMoDx Molecular Systems

What it is:  A family of scalable fully automated random-access systems for 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.

Why it’s cool: These instruments are as easy to use as a general chemistry analyzer, with continuous random access and sample in, answer out. The open nature of the system affords the lab greater flexibility and the dry chemistry allows for a longer shelf life for developing world, making it an easy to use, cost effective solution for price sensitive regions.

 

Company: Personal Genome Diagnostics (PGDx)

Product: PGDx Elio™ Tissue Complete Assay

What it is: A 500+ gene targeted panel that detects single nucleotide variants (SNVs), small insertion/deletions (indels), amplifications, rearrangements, microsatellite instability (MSI) and tumor mutation burden (TMB).

Why it’s Cool:  It’s the first standardized Tumor Mutational Burden assay - and can be used across 35 tumor types.  It has been analytically validated to demonstrate high precision, repeatability, and sensitivity, and has high concordance with whole exome sequencing.  The system offers standardized library prep, sequencing, and report algorithm.

 

Company: Qiagen

Product:  QiaStat-Dx® Respiratory Panel

What it is: A moderately complex real-time PCR upper respiratory panel which detects 21 Pathogens.

Why it’s Cool:  This 510k-cleared multiplex panel can identify the exact cause of a patient’s upper respiratory infections in as little as 1 hr, making it strong competition for Biofire, and Genmark. AND although Accelerate targets some of the same pathogens, their system is for lower respiratory bacterial targets.  The panel also provides cycle threshold (CT) values and amplification curves, which are quantitative indications of the amount of nucleic acids detected, a unique advantage for physician interpretation.  The QiaStatDx is designed to allow for an expanding test menu, with future capacity for up to 48 pathogens.

 

Company: Qvella

Product: FAST-ID^TM BSI Panel

What it is: Fully automated, on demand pathogen identification testing system with results in less than 1 hour.

Why it’s Cool: This easy to use (2 minutes of hands on time!) system is sample to answer and requires no cartridge assembly.  The genotypic assay detects over 95% of sepsis causing pathogens. The system comes with Qvella’s proprietary e-lysis™ technology, which produces PCR ready lysate, eliminating the need for multi-step extractions.

 

Company: Thermo Fisher Scientific

Product: Ion Torrent Genexus System

What it is: The first turnkey,  specimen-to-report integrated NGS system that delivers results in a  day.

Why it’s cool:  This new automated system is ideal for small to mid-sized hospital with little NGS expertise, or as a complementary platform for large, centralized labs. The system requires only five minutes of hands-on time (vs. 90 minutes for Illumina NGS systems), has the lowest sample requirement of any NGS system (10ng), and is designed to run small batches - even just one sample - cost-effectively to deliver a comprehensive genomic report. The system can be used with the Oncomine Precision Assay (50 genes) for testing solid tumor and liquid biopsy cancer samples, with more assays on the way for other application areas, including infectious disease, inherited disease and reproductive health. While the system is currently for research use only,  Thermo Fisher plans to seek FDA approval of the Genexus System to accelerate future development of a broad menu of diagnostic assays.  It's  automation makes it a first-of-its kind in the world.

With the advent of such sophisticated and clinically accurate molecular diagnostics technologies and continued partnership with pharma (which was ever clear at AMP), the holy grail of precision medicine is within reach.

Contact us today to learn more about how we can support your personalized diagnostic product commercialization at marketreadyrx.com