Targeting the needs in Point of Care Immunoassay

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Targeting the needs in Point of Care Immunoassay
Lab results without the lab
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Organisation

• BOARD
• Rolf Classon, Chairman
• Previously Chairman of Bayer Healthcare
• Werner Schafer, Director
• Previously President of Roche Lab Systems
• Gerard Vaillant, Director
• Previously Chairman of JJ Diagnostics
• Gerry Moeller, Director
• Previously President of Roche Diagnostics
• Jonathan Gee, Director
• Represents Spark Ventures
• Paddy Greenwood, Director
• Represents Viking Technologies

MANAGEMENT Neil Butler CEO Previously
founding MD of Oxford Biosensors Tim Carter
CSO Founder and MD of PiezOptic Inventor of
Enhanced Chemiluminesence Steve Ross RD
Director Key piezofilm technologist for past 6
years Sonja Johnston Quality
Director Chemistry Graduate Last 5 years in
Lifescience Quality Management Stafford Moss
Process Engineering Manager Stafford
Moss Process Engineering experience in Pharma /
Diagnostics Nigel Newton Finance Director
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Resource
Assay Development

• Purpose built facility at the Kent Science Park
• -12,000sqft
• - 30 full time staff
• Laboratories
• Cartridge Pilot Manufacturing Facility
• ISO 13485 certified

System evaluation (Whole blood)
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Product Development

• Developing an immunoassay system for use at the
  point-of-care
• Sensitivity and precision equivalent to lab-based
  tests
• Fast (5min)
• Wide dynamic range
• Capillary blood sample works with whole blood
• Simple test with no sample preparation designed
  for CLIA waiver

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Business Strategy

• Develop alliances with diagnostic majors
• License the technology for discrete fields of
  interest
• Partner To market, manufacture and handle
  regulatory affairs
• We provide the level of support required by
  Licensee
• Comprehensive IP cover
• Technology know how and show how
• Product development to clinical trial stage
• Pilot Cartridge facility for manufacture of trial
  batches and process characterisation
• Develop high alignment with licencees, possible
  future trade sale

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Market Strategy
Acute Care is a primary target for major
diagnostic companies. Our entrance to this field
will require a strong partner with licences for
key markers. Timescales are significant for the
development of some 5 tests (Tn, CKMB, D-Dimer,
BNP, HsCRP and / or MPO)
Market Settings

• Hospital / Paramedic acute conditions
• Heart attack markers
• Stroke Markers
• Infection / sepsis markers

• Longer Term Strategic target
• Need for rapid, high quality data
• Sensitivity and precision are key
• Competitive market, go with major

• Outpatient Clinics endo, cardio, diabetology
• Thyroid function
• Diabetes
• Prostate
• Cardiovascular
• Infectious diseases, requiring high sensitivity

• Chronic Care, point of entry
• High numbers of tests / device
• Early advocacy from Opinion Leaders
• More compact and higher utility market than
  Physicians Office

• Chronic care, later rollout
• Interest in similar chronic tests
• Lower utility per device
• Much larger number of sites

Primary Care Physicians Office As above
Thyroid, Diabetes, Prostate, Cardio
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TSH, our interest in thyroid function

• Excellent demonstration assay High sensitivity
  and dynamic range required
• The largest value immunoassay test in the lab
  today.
• Hypothyroidism in the US affects 20 million
  people, larger than diabetes
• Hypothyroidism is easily corrected, by a drug
  with no side effects.

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TSH, an opportunity exists for a more effective
diagnostic than the lab.
Need for improved screening
Need for improved management
Colorado Thyroid Disease Prevalence Study
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TSH, our performance objective
50
9000
The only PoC Competitor Thyrotest
HYPO
VIVACTA INITIAL PERFORMANCE TARGET 50- 0.075
mIU/L
3RD GENERATION LAB PLATFORM
HIGH
900
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NORMAL
NORMAL RANGE
pg / mL
mIU / L
90
0.5
THYROTOXIC
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0.05
0.02
VIVACTA ULTIMATE TARGET 50- 0.02 mIU/L
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• Piezofilm Detection Technology
• An ultrasensitive sensor with direct electronic
• measurement of binding kinetics

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Immunoassay System
capture
analyte
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Immunoassay System
capture
analyte
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Interrogation with a flashing LEDdifferentiates
between bound and unbound reporter
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Time domain measurements
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Direct electronic output
Reporter binding
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Analytical Sensitivity
Analytical sensitivity of 15 pg/mL
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Recent work focused on improving signal / noise
(improved detection limit and CV)
4 CV at 1 ng / mL
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Machine comparisons NEQAS samples

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Our Unique Features

• Sensitivity
• Low pg/mL, binding assays
• Dynamic range
• At least 4 orders of magnitude without dilution
• Whole blood capability
• Results produced in the presence of cells
• Simplicity (and hence cost)
• LED light source and charge/voltage measurement
• No sequential additions, separation or wash steps
• IP
• Strong

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Intellectual Property
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• Product Realisation

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Cartridge is the collection device

• Sample is drawn by capillary fill, not injected
• Looped to aid sample stability
• Sample containment for up to 5 min prior to
  insertion in reader
• Visible window provides fill verification
• 30uL sample volume metered, capillary break
  prevents overfill.
• Designed to work with whole blood, serum and
  plasma

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Cartridge construction

• Injection moulded core incorporates fluidic
  channel
• Rigid location of Piezofilm
• Moulded in acrylic
• 7 components assembled by pick and place

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Cartridge fluidics / Piezofilm

• Sample / reagent mixing managed by airdrive
• lt1 min to mix and deliver sample to analytical
  areas.

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Cartridge reagents

• Heparin dried down in collection channel
• Conjugated reporter, buffer and stabiliser dried
  down in capilary

Reagent/ reporter
anticoagulant
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Cartridge Analytical Areas

• 3 test areas
• Test (anti TSH)
• Negative control (isotype)
• Positive control (antispecies)

Test
-ve control
ve control
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Reader operating sequence

• Input Patient and user data, if required by
  administrator
• Cartridge inserted horizontally at front, print
  and blood fill window up
• Door closed
• Variable test time
• Reader will prompt user at end of test

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Reader Calibrations

• Cartridge batch calibration from 2D barcode
• LED calibration by on board film calibration
• Calibration from physiological interferent by
  negative blank

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Structured development plan, with continuous IP
output
First product development
Market Clearance
Pivotal FDA Clinical Trials
Delivery of batch of prototype commercial Readers
Disposable manufacture and delivery of prototype
Readers
10 / 08
2 / 09
07 / 09
12 / 09
09 / 09
Small Molecule detection
Multiparameter panels
Technology extension
Nucleic Acid detection
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Thank you
Lab results without the lab