Factors Influencing LC/MS/MS Moving into Clinical and Research Laboratories

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1 Factors Influencing LC/MS/MS Moving into Clinical and Research Laboratories Matthew Clabaugh, Market Development AACC Workshop St. Louis, MO September 17,

2 Factors Influencing LCMSMS Moving into Clinical Research and Clinical Labs For 2 Research Use Only. Not for use in diagnostic procedures.

3 Agenda How has Mass Spectrometry evolved and where is it headed? Why is Mass Spectrometry being adopted? Changing laboratory needs One big question to you. 3

4 Things Evolve 4

5 Hospital Lab Progress 5

6 Introduction of Mass Spectrometry into Clinical Diagnostics Potential for faster, more accurate results for clinical use Reduce total cost of ownership for routine in vitro diagnostics Proven analytical technology simplified for medical technologists and lab analysts 3200MD Series 6

7 New Challenges to MS vendors New Users You want who to run this system? New Software LIS integration Validation of LDT Response time for support/ service. Regulations Why do we have to do that? Court defensibility. Hospital purchasing agents. CSI expectations 7

8 FDA Classification of a Class I Mass Spec 21 CFR Mass spectrometer for clinical use A mass spectrometer for clinical use is a device intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. Specific clinical applications are classified as a Class II or III and may require a 510k or PMA. Other applications, depending on the intended use, may be classified as a Class III and require PMA approval. European IVD Directive, CE Marked Under the European IVD Directive, the 3200MD is classified as a General IVD with the following intended use: Intended to identify inorganic or organic compounds (e.g., lead, mercury, and drugs) in human specimens by ionizing the compound under investigation and separating the resulting ions by means of an electrical and magnetic field according to their mass. 8

9 Need for specificity and selectivity 9

10 Challenges and Issues for Clinical Labs Accuracy of results False-positives False-negatives Speed to results Complex samples High volumes Need for sensitivity and selectivity in quantitative and qualitative analysis Diagnostics is the new frontier for mass spectrometry 10

11 Pain management brings new issues and new labs Rapidly expanding lists. EIA is not specific enough GCMS is too expensive to use for PM. 11 For Research Use Only. Not for use in diagnostic procedures..

12 Forensic Toxicology Keeping up with the bad guys. LC/MS/MS technology at the forefront of forensic toxicology for analysis of new and rapidly changing designer drugs. 12

13 What is a synthetic drug? For Research Use Only. Not for use in diagnostic procedures.. 13

14 Scientific advantages of LC/MS/MS Greater selectivity and specificity Sensitivity Simplified sample preparation Short run times Multiple compound classes can be analyzed in a single run Reduced per sample costs And so on. 14

15 Economic Analysis Sent out costs. Reagents costs. Results delay. Obamacare Fixed rate of reimbursement. Competition Space consolidation 15

16 Changing needs of the lab Need for specific compound vs compounds. EIA is an indirect measurement while LCMSMS is direct measurement. Alternative matrix Blood spots Oral fluids LCMSMS offers specificity and cost effective analysis. 16

17 Other markets are going through the same change. Protein and Biomarker Research Discovering new biomarker candidates Verifying and validating biomarkers Advancing biomarkers toward use in clinical settings Food, Environmental, Forensics, Clinical Research Improving identification of contaminants in food and the environment Advancing forensic investigations through improved methods for toxicology Enabling greater confidence in results for clinical research Pharmaceutical and Small Molecule Discovering new drug candidates Advancing development processes 17 Helping to speed drugs to market For Research Use Only. Not for use in diagnostic procedures..

18 Increasing use of mass spectrometry for clinical research The Future Random access Infectious diseases Blood pathogens Influenza Biomarkers Protein/Peptide Quant Tissue Imaging DNA profiling. 18

19 Levels of available sensitivity to fit the needs of the application & SelexION 5500 Series Clinical Research Endocrinology, Dihydroxy VitD, Blood spot analysis and Biomarkers 4500 Series Forensic drug testing for synthetic and oral fluid drugs, sports doping and high throughput Series Forensic Urine Drug Testing, Clinical Research Vit D and Immunosuppressants

20 We need an analyzer not a component system. 20

21 Where do we go from here? Forget what you know and use your imagination. 21

22 Laboratory Instrumentation Evolution 22

23 One Big Question. What do you want/need a mass spec to be? Matthew.clabaugh@absciex.com

24 Trademarks/Licensing Not all AB SCIEX instruments are intended for in vitro diagnostic use, please consult your local sales representative or the AB SCIEX website for more information. The trademarks mentioned herein are the property of AB Sciex Pte. Ltd. or their respective owners. AB SCIEX is being used under license AB SCIEX. 24