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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


•  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


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


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


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


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


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.


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


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


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.

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