Development of Microfluidics Devices for Medical ... - Acamp

A Minaturized Testing Platform
for Molecular Diagnostics
Enabling Personalized Medicine
Linda M. Pilarski, PhD
University of Alberta
AHFMR Interdisciplinary Team Leader
(Alberta Innovates Innovates- Health Solutions)
17 November 2010

Personalized Medicine
The medical care of the future.
Tailor treatment to the molecular properties
of the person and/or their disease
- Need affordable molecular testing
- Need to test patients one at a time as
they present in clinic, to initiate treatment
- Usually need results from more than one
test, termed “multiparameter”
Our technology makes this approach affordable

“Market Pull”: A Need for Molecular Testing
• Point of care/minaturization advantages:
– Small sample volume
– Fast processing (30 -60 minutes)
– Portable instrumentation
– Low cost and automated
– Ease of use in resource-poor areas,
community hospitals, or sophisticated urban
centres
– Feasible in extreme environments

Testing Module (Gel Posts)
Everything but the
sample is polymerized
in the gel.
User needs only
add sample

laser
Gel post module
Heating element
Instrumentation is still
being developed
“Off the shelf”
components
Standardization is
critical
Learning where
variability occurs
Heat sink for cooling

Use laser induced emission of light
(fluorescence)
as method of detection
4 mm
9x9 Mold Gel Posts With fluorescence
Dye emits light only if the reaction is positive
All tests use the same dye

Need to create many copies of a gene or gene
segment to detect its presence
Testing module has to perform molecular
amplification technologies. One of these is
Polymerase Chain Reaction (PCR, thermal
cycling)

Can determine the number of gene copies
originally present by measuring amplification at
each cycle, called “real-time quantitative PCR”.
There is no need for pumping and valvingreaction
and detection occur within the gel post.

Gel Post Platform includes positive
and negative controls
1. Need to confirm that sample is not inhibitory
(avoid false negatives)
2. Need to confirm that in absence of sample,
no product is amplified (avoid false positives)
Instrument software will verify each test against
defined positive and negative controls:
Then report result.
The user never sees the raw data.

Tissues that have been directly tested
1. Body fluids – urine, saliva, plasma
2. Buccal swabs – cells from cheek lining
3. Genital swabs - STDs
4. Whole blood or bone marrow
- Can do all sample processing on gel posts
- Can follow patients over time to monitor
response to treatment
- Readily used in “rapid response” labs
or local clinics

Simultaneous testing for multiple pathogens or
biomarkers on the same gel post array:
“multiparameter testing” with no cross-talk
Test for multiple related markers/agents
- Fever panel
- Sexually transmitted disease panel
- Malaria panel
- Drug metabolism panel

Advantages for Community Hospitals
and Resource-Deprived Environments
1. Unprocessed clinical samples
2. Matches “gold standards”
3. Symptom based multi-test panels
4. “Yes/no” or quantitative readouts
5. Disposable reaction module
6. Simple result interpretation
7. Desiccate for storage
9. On board power and water
10. On board computer for data analysis
11. Low-cost/high volume manufacturability
12. Affordable “one at a time” testing

Applications using clinical samples
1. Malaria speciation and genotyping for drug resistance
2. Test Panel for Sexually transmitted diseases
3. Detection of tamoxifen non-responders
4. Risk Assessment for breast cancer
5. Typing panel for blood group antigens
6. Viral detection panel for transplant patients
7. Detecting tuberculosis and drug resistance
8. Fever panel
9. Diarrhea panel
Fields of Use Licensed to Aquila Diagnostics (Edmonton)
- Detection of blood borne infectious agents
- Blood group genotyping

AHFMR Team
Improving Heath Care
Access and Sustainability with
Minaturized Molecular Testing
Funded by
Alberta Innovates- Innovates
Health Solutions
(AHFMR ITG program)