factors influencing lc/ms/ms moving into clinical and
TRANSCRIPT
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© 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Factors Influencing LC/MS/MS Moving into Clinical and Research Laboratories Matthew Clabaugh, Market Development
AACC Workshop St. Louis, MO September 17,18 2013
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2 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Factors Influencing LCMSMS Moving into Clinical Research and Clinical Labs
For Research Use Only. Not for use in diagnostic procedures.
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3 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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.
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4 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Things Evolve
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5 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Hospital Lab Progress
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6 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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
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7 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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
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8 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
FDA Classification of a Class I Mass Spec 21 CFR 862.2860 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.
• 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.
European IVD Directive, CE Marked
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Need for specificity and selectivity
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10 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Challenges and Issues for Clinical Labs
Accuracy of results
– False-positives
– False-negatives
Speed to results
Complex samples
High volumes
Diagnostics is
the new
frontier for
mass
spectrometry
Need for sensitivity and
selectivity in quantitative and
qualitative analysis
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11 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Pain management brings new issues and new labs
For Research Use Only. Not for use in diagnostic procedures..
• Rapidly expanding lists.
• EIA is not specific enough
• GCMS is too expensive to use for PM.
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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.
Forensic Toxicology
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What is a synthetic drug?
For Research Use Only. Not for use in diagnostic procedures..
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14 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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.
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Economic Analysis
Sent out costs.
Reagents costs.
Results delay.
Space consolidation
Obamacare – Fixed rate of reimbursement.
Competition
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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.
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17 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Protein and Biomarker Research
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
– Discovering new
biomarker candidates
– Verifying and validating
biomarkers
– Advancing biomarkers
toward use in clinical
settings
Pharmaceutical and Small Molecule
– Discovering new drug candidates
– Advancing development processes
– Helping to speed drugs to market For Research Use Only. Not for use in diagnostic procedures
..
Other markets are going through the same change.
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18 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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.
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19 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
3200 Series
4500 Series
5500 Series
6500 & SelexION™
Levels of available sensitivity to fit the
needs of the application.
Forensic Urine Drug Testing, Clinical
Research Vit D and Immunosuppressants
Forensic drug testing for
synthetic and oral fluid
drugs, sports doping and
high throughput
Clinical Research Endocrinology,
Dihydroxy VitD, Blood spot analysis
and Biomarkers
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20 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
We need an analyzer not a component system.
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21 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Where do we go from here?
Forget what you know and use your imagination.
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22 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
Laboratory Instrumentation Evolution
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23 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
One Big Question. What do you want/need a mass spec to be? [email protected] 913 856 7236
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24 © 2013 AB SCIEX - Document number: IVD-MKT-11-0978-A
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.
© 2013 AB SCIEX.