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GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
> Enal Razvi, Ph.D. Biotechnology Analyst, Managing Director SELECTBIO US [email protected]
GENReports: Market & Tech Analysis
Mass Spectrometry
Market Snapshot
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
• The focus of this GEN Market & Tech Analysis Report is to frame some of the market trends operaAve in the broader mass spectrometry space
• We have been following the mass spectrometry marketplace and based on our analyses have idenAfied areas of opportunity—one of these areas of opportunity is the uAlizaAon of mass spectrometry for clinical diagnosAcs – This is an emerging field and there are currently a large number of laboratory
developed tests (LDTs) based on mass spectrometry – Very few IVDs based on mass spectrometry currently
• No Significant Penetrance of Oncology Space by Mass Spectrometry • More Mass Spec Kit and Device approvals in the DiagnosAc Space !
This Trend may Increase the number of Biomarkers that are Approved by the FDA ! The Biomarkers that are Currently Developed on Mass Spec Technologies in Research Laboratories are Difficult to Clinically Validate via Immunoassays
Topic IntroducAon and Scope
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Mass Spectrometry Market SegmentaAon and EvoluAon
1. MS Market Segments are Presented as Relevant to the Clinical Diagnostics Space 2. MS also Impacting Microbiology 3. Not Much Impact in Cancer/Oncology Space ! Anecdotal Reports for Cancer Biomarker Studies 4. Emerging Impact for Testing Proteins/Peptides ! Emerging Applications in Development 5. Multiplexed Mass Spec ! Detecting Proteins/Peptides en bloc
Research Market [RUO]
Clinical DiagnosAcs Market Segments
Impacted by MS
Newborn Screening
Drugs of Abuse TesAng
[Downstream Assay]
Prenatal TesAng
Metabolite TesAng [AA, FA]
Steroids [Endocrine Disorders—a major driver], Vitamins
Microbiology
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Developed and Marketed MS Systems Manufacturer Instrument Name Technology Disease Area[s] Addressed
Ionics Mass Spectrometry 3Q Molecular Analyzers Triple Quadrupole Mass Specs
Developed Methods for: Drugs of abuse, Pain panels and Hormones
Waters ACQUITY UPLC®/tandem mass spec Used by the World AnV-‐Doping Agency -‐ Drugs of abuse
MassTrak Immunosuppressants XE Kit Based around an LC/MS/MS system couple with UPLC (Acquity)
CE Marked for the measurement of immunosuppressive drugs tacrolimus and everolimus.
Acquity UPLC Ultra high pressure liquid chromotography system TherapeuVc drug monitoring, drugs of abuse
ACQUITY TQD
Bruker Daltonics MALDI Biotyper MALDI-‐TOF MS system for the idenVficaVon of microbes. Used in many European clinical microbiology laboratories
Shimadzu Axima performance MALDI-‐TOF MS MALDI-‐TOF based system integrates into Shimadzu’s Nanotrap Biomarker Discovery Plaborm ApplicaVon: Screening for known biomarkers
LCMS-‐8030 Triple Quadrupole Mass Spectrometer
Sequenom MassARRAY System MALDI-‐TOF based system, 384 and 96 well for research applicaVons
ApplicaVons: Genotyping & Copy Number, SomaVc MutaVon Profiling, Gene Expression, MethylaVon
Agilent Technologies 6460 Triple Quad LC/MS Drugs of abuse tesVng
RapidFire/MS 300 & 360 SPE-‐based high throughput TOF MS system Whole protein and fragment-‐based analyses, drug-‐drug interacVon, CYP inhibiVon,
metabolic stability, Pgp inhibiVon (Digoxin), plasma protein binding, permeability (Caco-‐2 and PAMPA) and complex samples.
Poroshell 120 AnalyVcal HPLC and UHPLC Clinical Sample Prep
Bond Elut Plexa PCX Solid Phase ExtracVon Clinical Sample Prep
Perkin Elmer AxION 2 TOF MS Clinical MSMS/ Tandem Mass Spec CE marked for IVD in countries where appropriate. Not in US & Canada, Drugs of abuse tesVng
CHS Steroid Profiling Kit
Clinical MSMS informaVcs
MSMS Vitamin D Kit
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Manufacturer Instrument Name Technology Disease Area[s] Addressed
Thermo Fisher PAiNACEA SoluVons Transcend TLX System Automated Sample prep system Pain management and drugs of abuse analysis
TSQ Quantum access MAX MS HESI-‐II heated electrospray ionizaVon probe LCMS system Endocrine Analysis
LTQ Orbitrap XL Hybrid FTMS system
MSIA Pipehe Tips System employs a micro immunoaffinity column which is inserted into a pipehe Vp
Immuno-‐enrichment for MS studies in quanVtaVve clinical proteomics and Biomarker Research
AB Sciex Clinical Research Mass Spec Tandem Mass Spec (LC-‐MS/MS)
Steroids, Vitamin D & Metabolites, T3/T4, Homocysteine, Catecholamines, Bile Acids, Hamoglobin, PepVdes & Proteins, Purines & Pyiridimines
TherapeuVc Drug Monitoring
Inborn Errors of Metabolism
Toxicology Research
Standards & Reagents Amplifex Diene Reagents Vitamin D3 and D2 enrichment
Amplifex Keto Reagents
aTRAQ Kits for Amino Acid Analysis in Hydrolysates
aTRAQ Kits for Amino Acid Analysis in Physiological Fluids
SISCAPA Provide analyte specific affinity reagents to enrich for pepVde/protein quaniVtaVon using MRM MS
Used for the detecVon of thyroid cancer biomarker Thyroglobulin
Santa Cruz (SCBT) Provide reference succinylacetone isotopes/standards
Biomerieux VITEK MS -‐ Appears not to be available in the US MALDI TOF MS Rapid IdenVficaVon of Microorganisms
Developed and Marketed MS Systems
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Manufacturer Instrument Name Technology Disease Area[s] Addressed
Accugenix AccuPro ID
Copan USA MALDI -‐ Trace
RFID tagging system for traceability of organism idenVficaVon tests performed using seeded target plates
Developed and Marketed MS Systems
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Under Development MS Systems Department, InsAtuAon Disease Area Addressed MS Technology PlaXorm ASR/AddiAonal InformaAon
AB Sciex TripleTOF 5600 System Under development to perform MRM-‐like analysis. Possibility to perform analysis of proteins within human plasma
Agilent Agilent 6430 QqQ Mass Spectrometer Under development for the monitoring of illicit drug use looking at MRM transiVons
SimulTOF Systems SIMULTOF MS Working on Mass Spectrometric Immunoassays (MSIA) in the labs of Dr Randall Nelson, Arizona State
Bristol Myers Squibb QWBA and Imaging Mass Spectrometry by MALDI Assessment of Ocular distribuVon of drugs
Biological Sciences Division, Pacific Northwest Laboratory
AnVbody-‐free strategy that involves PRISM (high-‐pressure, high-‐resoluVon separaVons coupled with intelligent selecVon and mulVplexing) for sensiVve selected reacVon monitoring (SRM)-‐based targeted protein quanVficaVo
Hannover Medical School
Diagnosis of Acute RejecVon in Renal Transplant PaVents by Urine Mass Spectrometry Analysis of the pepVde pahern in Urine
Rambam Health Care Campus
Diagnosis of Pompe Disease using Tandem Mass Spec
Analyte: Alpha Glucosidase acVvity. The development of a comprehensive biochemical assay for detecVon of Pompe disease (glycogen storage disease type II), to be implemented in the Newborn screening program among the Israeli populaVon.
Obstetrix Medical Group
AmnioVc Fluid Tandem Mass Spectrometry for Pregnancies Complicated by NIH and Severe Symmetrical IUGR Actually project was terminated
Vanderbilt University
Analysis of Brain Tumors Using Matrix Assisted Laser DesorpVon/IonizaVon Mass Spectrometry
Data from different brain Vssues including tumors of different histological sub-‐types will be analyzed for unique protein signatures. These protein signatures will then be staVsVcally correlated with clinical data including Vme to tumor progression and response to therapy. The goal of this study is to determine molecular paherns that will be more predicVve of tumor behavior, thus leading to an improved understanding of the basic biology of these poorly understood cancers. This in turn, may lead to more refined therapies and improved outcomes.
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Department, InsAtuAon Disease Area Addressed MS Technology PlaXorm ASR/AddiAonal InformaAon
NCI
Blood Sample Analysis in PredicVng Overall Survival in PaVents With Recurrent or MetastaVc Head and Neck Cancer using MALDI MS
This research study is looking at blood sample analysis in predicVng overall survival in paVents with recurrent or metastaVc head and neck cancer
NCI
Early DetecVon of Epithelial Ovarian Cancer Using Exhaled Breath Markers: GC/FT-‐ICR Mass Spectrometry and Canine OlfacVon
Vanderbilt-‐Ingram Cancer Center
Serum and Exhaled Breath Condensate MALDI-‐MS of Lung Cancer (SPORE)
Pierre P. Massion, MD, Vanderbilt-‐Ingram Cancer Center, Ability of proteomic paherns to detect and discriminate lung cancer
Columbia University -‐ The Center for InfecVon and Immunity
UVlity of MassTag PCR as a tool for molecular diagnosVcs and pathogen discovery
MassTag PCR is a mulVplex PCR assay MassTag PCR is a mulVplex PCR assay that uses a library of>60 disVnct low molecular mass tags to code for microbial gene targets by conjugaVng each primer species with a disVnct mass tag via a photocleavageble linkage. Aner PCR amplificaVon, separaVon of amplificaVon products from unincorporated primers and release of mass tags from the amplificaVon products by UV irradiaVon, tag idenVty is analyzed by mass spectrometry.
Biomerieux TrypVc digesVon followed by LC-‐ESI-‐QqQ in SRM mode for Pathogen ClassificaVon.
MulVplexed detecVon of 124 pepVdes from 17 staphylococcal proteins, enabling simultaneously: an idenVficaVon at the species or sub-‐species level, a screening for Methicillin-‐resistant Staphylococcus aureus (MRSA) and toxins producing strains.
Mayo Clinic
SensiVve LC-‐MS/MS Estradiol/Estrone Method developed on the Agilent UPLC 1290 and 6490 Triple Quad LC/MS
An eight and one half minute, sensiVve LC-‐MS/MS method has been developed to detect 17beta-‐estradiol (E2) and estrone (E1) in human sera by derivaVzaVon with dansyl chloride.
Washington University School of Medicine OpVmizaVon of AnVmicrobial Therapy
Culture-‐Independent IdenVficaVon of Pathogens in Urine Specimens using MALDI-‐TOF MS
Lawrence Berkeley NaVonal Laboratory
MEA (Silicon based monolithic mutlinozzle emiher array) Chips in Nanoelectrospray Mass Spec
Waters Alzheimers Disease SPE-‐LC-‐MS/MS
QuanVtaVon of Amyloid β PepVdes in Cerebrospinal Fluid -‐ Analytes: 1-‐38, 1-‐40 and 1-‐42 fragments of Amyloid Precursor Protein
Under Development MS Systems
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
Department, InsAtuAon Disease Area Addressed MS Technology PlaXorm ASR/AddiAonal InformaAon
University of Stockholm ALS/PDC LC-‐MS/MS SRM
QuanVtaVon of Amyloid β PepVdes in Cerebrospinal Fluid -‐ Analytes: 1-‐38, 1-‐40 and 1-‐42 fragments of Amyloid Precursor Protein
University of New South Wales Suicide Risk Analysis GC/MS Quinolinic acid
Bruker and SISCAPA No specific disease classes disclosed MALDI-‐TOF
Measurements of clinically-‐useful biomarkers Large-‐scale clinical validaVon of protein biomarkers
Under Development MS Systems
GENReports: Market & Tech Analysis, Produced by Enal Razvi, Ph.D. © 2014 GENengnews.com
In Summary
• This GEN Report provides a snapshot of the qualitaAve trends in the mass spectrometry space—focusing on developed systems and the pipeline of systems under develoment
• There are many LDTs based on mass spectrometry currently addressing a number of analytes
• The challenge has been the translaAon of these LDTs into FDA-‐approved bona fide diagnosAc tests [IVDs]
• There is a regulatory push in this direcAon: – CLIAC RecommendaVons
• Newborn Screening • Drugs-‐of-‐Abuse TesVng
• FDA and CLIAC guidance on running Newborn Screening Tests for Amino Acid Disorders and AcylcarniAnes [“Tandem Mass Screen”] using LC-‐MS/MS, AcylcarniAne also has uAlity in forensics market.
• Source: CLIAC RecommendaAons for Good Laboratory PracAces for Biochemical GeneAc TesAng and Newborn Screening for Diagnosis and Monitoring of Inborn Errors of Metabolism.