Factors Influencing LC/MS/MS Moving into Clinical and ...

© 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

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.


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.


Things Evolve

http://3.bp.blogspot.com/-wJZJgokSg58/ThcplUq0o5I/AAAAAAAADO8/HvtibJvMCrY/s1600/Evolution+Humane.gif


Hospital Lab Progress


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


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


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


Need for specificity and selectivity


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


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.


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


What is a synthetic drug?

For Research Use Only. Not for use in diagnostic procedures..


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.


Economic Analysis

Sent out costs.

Reagents costs.

Results delay.

Space consolidation

Obamacare – Fixed rate of reimbursement.

Competition


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.


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.


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.


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


We need an analyzer not a component system.


Where do we go from here?

Forget what you know and use your imagination.


Laboratory Instrumentation Evolution


One Big Question. What do you want/need a mass spec to be? [email protected] 913 856 7236

mailto:[email protected]


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.

Factors Influencing LC/MS/MS Moving into Clinical and ...

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