Clinical LCMS technology update WELCOME. Denis Calnan. Clinical Business Development Manager (Northern Europe) 2011 Waters Corporation

Transcription

1 Clinical LCMS technology update WELCOME Denis Calnan 2011 Waters Corporation Clinical Business Development Manager (Northern Europe) 1

2 About Waters Facts and Figures $1.8 billion in annual revenue Direct sales/service in 97 offices serving 54 countries worldwide 4,500 employees Milford, Massachusetts Corporate Headquarters Research & Development Manufacturing: ISO 13485, CE IVD Wexford Local Expertise: European MS Headquarters in Manchester Demo Lab in Sollentuna, Sweden Manchester, England MS Technologies Centre 2011 Waters Corporation 2

3 Waters Differentiation Your Results 2009 Waters Corporation COMPANY CONFIDENTIAL

4 Clinical Operations Group Formed within Waters autumn 2004 Build critical mass to support growth Clinical staff o Sales o Service o Applications o Product management o Regulatory o Over 1500 clinical LCMS installations worldwide 2011 Waters Corporation 4

5 Instrument and Solutions Portfolio ACQUITY TQD Most popular, workhorse instrument ACQUITY Xevo TQ and Xevo TQ-S High Sensitivity Analysis Challenging samples/matrices Lowest detection levels for Steroids Exact mass screening [UPLC-TOF] Forensic Toxicology screening 2011 Waters Corporation 5

6 ACQUITY UPLC Introduction: High Productivity % UPLC/MS HPLC/MS Time Waters Corporation 6

7 Simple Access On-board fluidics Advanced LC/MS/MS More Accessible More Reliable More Productive 2009 Waters Corporation COMPANY CONFIDENTIAL

8 Simple Access XX LC/MS System check: Run % Peak area = Time LC/MS System check: Run % Peak area = LC/MS System Check 0 Time 2009 Waters Corporation COMPANY CONFIDENTIAL

9 Waters Application portfolio Endocrinology apps Steroid panel (Cortisol, 17-OHP, A4) Plasma metanephrines 25-OH Vitamin D2 + D3 Toxicology apps Confirmation panels Opiates Benzos THC Therapeutic drug monitoring Immunosuppressive drugs Anti-epileptics Anti-psychotics Neonatal screening Supplied via PE 2011 Waters Corporation 9

10 Vitamin D System Solution ACQUITY TQD LCMS System MassLynx Software OpenLynx walk up software Sample Prep Connection Insight (i Assist, i Alert, i Help) Clinical Total Assurance Support Plan Over 20 Waters LCMS Systems installed in the UK performing Vitamin D analysis 2011 Waters Corporation 10

11 Semi-Automated Sample Preparation System Tecan Freedom EVO 100 Fixed configuration Plate vortex mixer SPE vacuum manifold Tube racks Reagent troughs EVOware PC Laboratory will need to supply Centrifuge compatible with 96 deep well plates Microsoft Excel Tecan Freedom EVO Waters Corporation 11

12 Xevo TQ and Xevo TQS 2009 Waters Corporation COMPANY CONFIDENTIAL

13 Xevo TQ-S A tandem quadrupole mass spectrometer For high performance LC/MS/MS applications Outstanding quantitative LC/MS/MS performance & Enhanced qualitative LC/MS/MS capabilities 2009 Waters Corporation COMPANY CONFIDENTIAL

14 Simple Access On-board fluidics Advanced LC/MS/MS More Accessible More Reliable More Productive 2009 Waters Corporation COMPANY CONFIDENTIAL

15 Simple Access XX LC/MS System check: Run % Peak area = Time LC/MS System check: Run % Peak area = LC/MS System Check 0 Time 2009 Waters Corporation COMPANY CONFIDENTIAL

16 High Sensitivity Optimized gas flow dynamics High temperature desolvation (650C) Thermally regulated ionisation chamber Highly efficient ionisation High LC flow rates High aqueous solvents Designed for Performance, Usability & Serviceability 2009 Waters Corporation COMPANY CONFIDENTIAL

17 Stepping up to the challenge Xevo TQ-S Larger sampling orifice 2011 Waters Corporation 17

18 Electric Field Diffuse Ion Cloud Off-Axis design Wide Ion Tunnel Conjoined to Narrow Ion Tunnel Maximising signal Minimising noise 2011 Waters Corporation 18

19 Xevo LCMSMS 2009 Waters Corporation COMPANY CONFIDENTIAL

20 Perkin Elmer multi Steroid Kit and Waters Xevo TQS system PE have an IVD CE marked combined 10 steroid kit: Androstenedione, aldosterone, corticosterone, cortisol, 11-deoxycortisol, 11 progesterone, 17 alpha hydroxyprogesterone, testosterone, DHEA and DHEAS This will be validated for use with Xevo TQS Support available through P.E and Waters Several Steroid panels developed by Waters Customers 2011 Waters Corporation 20

21 PE Steroids kit and Xevo TQS 2011 Waters Corporation 21

22 PE Steroids kit and Xevo TQS 2011 Waters Corporation 22

23 IVD-Labeled Products Value to Clinical Customers What are the implications of a medical device (IVD label) designation on Waters products? Designates that Waters manufactures medical devices (not general laboratory or research use only devices) Products have been designed, developed, and manufactured in accordance to and compliance with the Quality System Requirements (US) and In Vitro Diagnostics Directive (EU) ISO EU IVDD 98/79/EC Intended to provide the market with safe and effective products Waters manufacture to IVD CE certificated Standards Waters Corporation 23

24 Therapeutic Drug Monitoring System Solution ACQUITY TQD LCMS System MassLynx Software OpenLynx walk up software Waters MassTrak Immunosuppressants XE Kit Connection Insight (i Assist, i Alert, i Help) Clinical Total Assurance Support Plan Over 45 Waters LCMS Systems installed in the UK performing TDM 2011 Waters Corporation 24

25 MassTrak Immunosuppressants XE Kit Calibrators Freeze-dried whole blood matrix Quality controls Internal standards Isotopically labelled (deuterated) Everolimus Ascomycin (structural analogue of Tacrolimus) Tuning mixture for instrument tuning Waters cartridge column MassTrak TDM C18 cartridge column, 2.1 mm x 10 mm Number of samples per kit 500 total tests including QC s, calibrators, approximately 350 samples Directions for Use Certificate of Analysis 2011 Waters Corporation 25

26 Introducing Acquity Online SPE Manager (OSM) A UPLC -enabled online solid phase extraction system 2009 Waters Corporation COMPANY CONFIDENTIAL

27 OSM Cartridges 2011 Waters Corporation 27

28 Tox Screening 2009 Waters Corporation COMPANY CONFIDENTIAL

29 TOF basics: What s in the box? Flight tube: defined length Pusher and detector Heavier ions have less velocity and take longer to travel along this path Hence, ions are separated by mass Mass accuracy to 4 decimal places 2009 Waters Corporation COMPANY CONFIDENTIAL

30 TOF basics: m/z ? The number of elemental composition results for each mass can be reduced by setting the mass error to a lower value. This is only valid if the mass accuracy of the system is acceptable. Elemental composition of high energy data Search C20H21N = Cyclobenzaprine 2009 Waters Corporation COMPANY CONFIDENTIAL

31 % % % % % % Database creation: MS method MS e Collection of unrestricted dataset m/z MS E mode (collision energy ramp 10-40eV) Low collision energy mode to produce precursor ion data MS MS m/z time m/z MS E time Same conditions used to prepare database and perform routine analysis m/z High collision energy mode to produce fragment ion data MS E 2009 Waters Corporation COMPANY CONFIDENTIAL

32 Validity of fragments MS E Collision energy ramp V Confirmed using MassFragment TM Low energy MS spectrum 9.4 min = temazepam 2009 Waters Corporation COMPANY CONFIDENTIAL

33 TOF offers mass measurement to 4 decimal places High confidence in identification High sensitivity in full scan Distinguishes them from compounds of similar mass Complete dataset retrospective analysis possible Can perform targeted or non-targeted analysis TOF permits creation of databases without reference material TOF is the only way to look for true unknowns & permits prediction of elemental composition 2009 Waters Corporation COMPANY CONFIDENTIAL

34 Accurate Mass screening Forensic Toxicology Method with 900 compounds database Technical brief Waters Corporation COMPANY CONFIDENTIAL

35 Why Waters? Proven System Solutions provider into the Clinical Diagnostic Market since 1994 Methods and Chemistry Consumables ISO, IVD, CE manufacturing, Single vendor complete solution Experienced back up and support team with understanding of unique clinical market demands. Strong publication record Fully committed to further clinical product development to support future business needs 2011 Waters Corporation 35

36 Thank You For Your Attention Any Questions? 2011 Waters Corporation 36