Osteoporosis Assessment Update

What’s New in 2005

 Hologic Product Line 2004

10 Second
upgradable Discovery A/SL Spine/Hip BMD
with IVA
SL BMD
Discovery C/W 10 Second Spine/Hip
BMD with IVA
Discovery Ci Wi 30 Second Spine/Hip BMD
(no imaging)
Explorer 90 Second Spine/Hip BMD
(no imaging)
Sahara Ultrasound / pDXA
 Hologic Product Line 2005

upgradable 10 Second
Discovery A/SL
Spine/Hip BMD
with IVA
SL BMD
Discovery C/W 10 Second Spine and
Hip BMD with IVA
Discovery Ci Wi 30 Second Spine / Hip BMD
Optional IVA
Explorer 90 Second Spine / Hip BMD
Optional IVA
Sahara
Ultrasound Screening
 Explorer

• 90-Second BMD
• 7 mR Radiation Dose
• 10 Second IVA ( Late Winter 2005)
Discovery i Series

• 30-Second BMD
• 10 mR Radiation Dose
• 10 Second IVA (Late Winter 2005)
Discovery Series

• 10-Second BMD
• 7 mR Radiation Dose
• New RVA
 Image Comparison
Prodigy Explorer Discovery i Discovery
RVA – Radiologic Vertebral Assessment

• Double Resolution
• 15 Second Scan
• Launch at RSNA
• Standard on Discovery
• Upgrade Opportunity

LVA IVA RVA

 Resolution Comparison
?? lp/mm 0.9 lp/mm 1.8 lp/mm

DVA/LVA IVA RVA

(GE/Lunar)
 List Pricing
• Explorer
– IVA $10,000
– Physician’s Viewer $2,500
– CADfx $7,500
• Discovery I
– IVA $10,000
– Physician’s Viewer $2,500
– CADfx $7,500
• Discovery
– RVA Standard
– Physician’s Viewer Standard
– CADfx Standard
 Why Imaging?
• Combined BMD/Fracture Assessment is the standard of
care
• 20 - 25% of postmenopausal women have fractures
• 30% of women needing treatment are missed without
IVA
• New ISCD Training and Clinical Guidelines
 QDR Mobility
• Enter Patient Risk Factors
• Remote – Portable Reporting
• Wireless Networking
• 1st Shipments August 2004
Physician’s Viewer 5.0

• DICOM
Query/Retrieve
• DICOM Send
• Central Server
• Multiple Interpreting
Physicians
 Pediatric Software
• New Pediatric Reference
Data
• Auto Pediatric Total Body
• No T-scores under age 20
• Available November 2004
• Must Have Version 12.3
 Patient Recall Lists
• Generate recall letters for follow-up examination
• Multiple output formats available
• Query based on previous results or exam date
 Database Export Tools
• Export data customized to user defined criteria
• Provides a flexible solution for data analysis
 Online Data Conversion
• Input Data from Any
DXA system
• Automatically
Converts GE Lunar
and Norland Data
• Allows seamless
follow-up after
system upgrade
• Allows follow-up of
patients from other
DXA centers
 HIPPA Privacy Tools

• Removes confidential
patient information
• Protects patients
privacy
• Complies with HIPPA
Guidelines
Key Selling Points
Major Hologic Advantages
• Superior BMD Technology
– Solid Hardware Platform
– Unique Software Features
– Faster Throughput
• Superior Imaging Capabilities
– AP/LAT Imaging
– High-Resolution Images
• Superior Connectivity
– DICOM
– Physician’s Viewer
– Report Writer
– HIS/RIS Integration
 Detector Array
Superior data acquisition is obtained
using Hologic fan-beam technology
– 3.5-8 times the number of
detectors (54/64/128 vs. 16 on
Prodigy)
– Acquires more data at a scan
speed similar to Prodigy
– More detectors result in more
data
– Provides superior image
quality, comparable to lateral
radiographs
Internal Reference System
Hologic
• Patented internal reference drum
eliminates the need for daily
calibration
• Patient values are compared to
known drum values
• Samples six data points per pixel
• Composed of bone and tissue
equivalents
• Continuous Calibration
• Provides Data Stability
• Provides Data Compatibility
Lunar
• Standard requires daily
calibration
 System Quality Control
• Anthropomorphic phantom simulates in
vivo conditions
• Calcium hydroxyapitite composition, with
a radiographic density close to that of the
human skeleton
• Proven to detect densitometer drift not
possible with competitive phantoms
• Assures long-term system stability and
performance
• The standard for QC in pharmaceutical
trials, regardless of the densitometer used
 Energy Switching Technique

• Energy Switching uses higher energies 140/100

• Higher Energy means better penetration
• Better Penetration give the ability to measure larger patients
• Separate Energy readings means no pile-up or crossover
 X-ray Source

• Full-size, high-capacity x-ray tube

• Source contains oil to eliminate
heat damage
• Eliminates need for cool-down
period
• Track record of reliability,
unmatched by the competition
• Lunar warrantee does not cover
tube
Data Acquisition Technique
• Hologic fan-beam
captures data in a single
pass
• No overlap or under-
sampling of data
• Precision is independent
of scan speed
• Optimal approach for
imaging comparable to x-
ray
Lateral BMD

• Supine positioning for lateral

BMD results in better precision
over decubitus positioning
• Paired AP/lateral scans result in
improved precision by correcting
for variability in the scanning
field due to thickness and tissue
composition (baseline
compensation)
Lateral BMD
• Recent validation study by Lunar shows
poor precision using Prodigy for
decubitus lateral scans (3.4%)
• Poor precision eliminates benefit of
lateral measurements on Prodigy (least
significant change 9.52% vs. 2.4% on
Discovery)
• Supine lateral measurements on the
QDR4500A had a precision of 0.9%
• Supine lateral measurements are more
reliable and allow for early indication of
bone loss or response to therapy
 Proper Arm Height for Imaging
• 24” table height allows for imaging of
the entire spine
• Prodigy only has 16” which is too
small for most patient’s shoulders
• Shoulders that will
will fit
fit under Prodigy
c-arm
– 15% of females
– 1% of males
• Increasing distance would increase
cost of Prodigy significantly
 Proper Radiographic Technique
• Imaging
– 100 kVp
• Hologic
– 140 kVp
• GE lunar
– 76 kVp – Too Little Power to Penetrate
AP and Lateral IVA is Necessary to Accurately
Assess Fracture Status

• Lateral IVA does not show all

fractures
– Without an AP scan this
fracture would have been
missed
– Without the AP this patient
would have been
misdiagnosed
• Only 10 seconds for additional
AP scan
• No AP capability on Prodigy
• 3 Minutes on Prodigy
 IVA vs. LVA
Image Pro Prodigy LVA • Side by Side Comparison
– Same Patient
– 54 year old female
– Scanned 1 day apart
– Both done with recommended
scan modes
• The difference is clear
– Hologic = Crisp, sharp images in
10 seconds
– Prodigy = Blurred, poor quality
images in 3 minutes
 IVA vs. LVA
IVA Prodigy LVA
 Independent Comparison
• “All Hologic scan modes provided
consistently better resolution than any of
the GE-Prodigy scan modes.” Jankowski
ICSD 2004
• “In areas of fan-beam overlap, GE-Lunar
scans have marked degradation of vertical
resolution.” Jankowski ISCD 2004
• “The Hologic systems provided
consistently better resolution than the
Prodigy” Jankowski ASBMR 2004
• The radiographic phantom used did not
have sufficiently coarse gradations to
accurately quantify the resolution on the
Prodigy.” Jankowski ASBMR 2004
 IVA / LVA References
• IVA References • LVA References
– Blake 1997 – Barden (GE Lunar)
– Klucas 2001 – Volkes 2002
– Greenspan 2001
– Nattrass 2001 (2)
Quotes from Lunar promotional
– Genant 2000
materials form studies
– Schousboe 2001
performed on Hologic
– Rea 2000
scanners
– Rea 2001
– Rea 1998 (2)
– Emond 2000
– Ferrar 2001 (2)
– Gordon 2001
– Schousboe 2001
Express Scan

• OnePass acquisition
technique
• 10-second acquisition
for Spine, Hip and
IVA
• 1% In vivo precision
Express Exam

• Automated scan
acquisition
• Reduces operator
keystrokes by 25%
• Customizable
procedure sequencing
maximizes workflow
Tech Tips

• Visual tutorial
• Eases use
• Simplifies training
• Improved scan quality
CADƒx
• Computer aided fracture
assessment
• Simplified IVA
interpretation
• Quantitative
confirmation of vertebral
deformities
• Displays degree of
vertebral compression
• Improves confidence in
interpretation
 IRIS: Integrated Radiology Informatics
System

• DICOM Worklist
• DICOM image storage
• Remote softcopy
interpretation
• Electronic report generation
• HL7 Output
 QDR Mobility

• Enter Patient Risk Factors

• Remote – Portable Reporting
• Wireless Networking
Selling Against GE Lunar, DMS,
and Norland
 Lunar Models

• Pencil Beam Technology

– DPX NT (Full/Compact)
– DPX Bravo
– DPX Duo
• Limited Fan Beam Technology
– Prodigy – Oracle, Vision, Pro, Advance,
Advance Plus
 DPX Bravo

• Pencil Beam Technology

– Obsolete Technology
– Slow Scans
– Low Resolution
– Limited X-ray Energy
– Photon Counting
– K Edge Filtration
 DPX Technical Limitations

• Calibration
– Manual - every 4 hours
– CV as high as 2.0% - QDR 0.6%
• Scan Speed - Weight Dependant
– 5 Minutes per site
– 20 Minute whole body
• Rice Bags Necessary for Hip Scan
 DPX Duo

• Combined DXA and

Exam Table
• Expensive
• Same Technical
Limitations as the Bravo
 Prodigy
• Same Technical Issues as
DPX
– K Edge Filtration
– Photon Counting
– Edge Detection
• Data Acquisition Errors
– Over/Under Sampling
• Poor Image Quality
 Prodigy Advance
• Announced at RSNA
– 350 Lb Weight Limit
• “New Frame design supports 350lb
patient weight” Prodigy Advance Launch
Presentation
• Low energy output limits weight
– 10 Second BMD Mode
• “QuickView enables 10 sec scan, BUT,
we recommend 30 sec mode for
precision.” Prodigy Advance Launch
Presentation
• Still takes 3:18 for LVA
– Washable Table Pad
– 15 “ Flat Panel Monitor
K-Edge Limitations
• K-edge filtration uses
lower energy x-ray
beams (70/36)
• Requires simultaneous
interpretation of high and
low energy photons
• Inherent data overload
(pulse pile-up)
• Number of x-rays
exceeds detector
processing capability
• Skips and interpolates
data to speed up scan
acquisition... a sub-
optimal design solution
Detector Crossover
Lunar Prodigy
 Limited vs. True Fan Beam

• Limited angle fan-beam

– beam overlap Prodigy
– endplate blurring
– low-resolution
– slow
• True fan-beam
– no beam overlap
– unique data sampling
– high-resolution QDR-4500
– fast Discovery
 Rectilinear vs. Isocentric Acquisition
• Prodigy uses rectilinear acquisition
– Multi-pass acquisition
under-samples data
– Multiple sampling of
same data (overlapping
data), leads to confusion
in analysis
– Inadequate penetration
of low-energy x-rays
– Patient positioning and
size affect degree of
overlapping or under-
sampling
• Hologic fan-beam acquires image
without overlapping or under-
sampling
 Lunar Claims
• Fan-Beam Done Right
• No Magnification
• Less Dose than other Fan-Beam Systems
• Near Radiographic Quality Imaging / LVA
• Advanced Hip Analysis
• Direct to Digital
• 30-Second Scan Speed
• Best Precision
• One Scan – One button DXA
• CAD
 Magnification
• Claims wide-angle fan-beam
causes magnification errors and
blurs edges
– Shows Hologic fan-
beam angle at 30oo
• Actual Hologic fan-beam angle
is only ±7oo
• Prodigy angle is 4.5oo
• Hologic and Prodigy have the
SAME magnification factor (2
for Prodigy; 2.1 for Hologic)
– Fan-beam angle is just
one component used to
calculate magnification
 “Different” DXA Geometries aren’t that different
Geometric magnification is similar for commercial DXA
systems

42” Geometric Geometric

26.5”
Magnification factor Magnification factor
= 42” / 17” = 2.5 = 26.5” / 12.5” = 2.1

12.5”
17”

True fan-beam system Limited angle fan-beam system

fan angle +/- 7 degrees fan angle 4.3 degrees
(Discovery / QDR-4500) (Prodigy)
“Different” DXA Geometries aren’t that different Magnification
(size of the shadow) effects BMC and Area, but NOT BMD

•“Although the change from pencil to fan-beam geometry significantly

affected AREA and BMC data, the effect on the clinically more important
BMD measurements was negligibly small.”

Blake, G. M., J. C. Parker, et al. (1993). “Dual X-ray absorptiometry: a comparison

between fan beam and pencil beam scans.” Br J Radiol 66(790): 902-6.
•“The recent introduction of dual X-ray absorptiometry (DXA) systems with
fan-beam instead of conventional pencil-beam scanning geometry represents
a significant technical advance in bone densitometry.”

•“This magnification, which occurs in the medial-lateral direction but not in

the craniocaudal direction, does not affect bone mineral density (BMD).”

Griffiths, M. R., K. A. Noakes, et al. (1997). “Correcting the magnification error of

fan beam densitometers.” J Bone Miner Res 12(1): 119-23.
 Radiation Exposure

• Claim Prodigy has a 3-5 lower dose than other fan-beam

densitometers
• Discovery fan-beam dosage for BMD is only 7 mR
entrance
• Prodigy dose is 8.3mR for thick patients
• Neither dose is excessive
• 1/4 of chest x-ray (less than a cross country flight)
 Image Pro vs. LVA
Image Pro Prodigy LVA • Side by Side Comparison
– Same patient
– 54 year old female
– Scanned 1 day apart
– Both done with recommended
scan modes
• The difference is clear
– Hologic = Crisp, sharp images
– Prodigy = Blurred, poor quality
images
 Image Pro vs. LVA

Image Pro Prodigy LVA

LVA Scan Time
 Advanced Hip Analysis

• Hip Axis Length

• Dual Hip
• Upper Neck
 Hip Axis Length
The Clinical Reality
What Does Lunar Say About Advanced Hip
Analysis?
“The Ultimate
clinical utility of
HAL measurements
remains to be
determined”
Ken Faulkner PhD
GE Lunar
What Does Lunar Say About Advanced Hip
Analysis?
“Has HAL been
shown to predict
fracture? Yes.
However, it is a
moderate to weak
predictor, as
compared with BMD
at the hip”

Ken Faulkner PhD

GE Lunar
What Do Experts Say About Advanced Hip
Analysis?

“Upper neck is
considerably less
reproducible which
diminishes its potential
usefulness as an
indicator of fracture
risk”
Mike O’Connor PhD,
Mayo Clinic
 The Truth Behind DXA Detectors
1st Generation 2nd Generation 3rd Generation
Pencil-Beam Multiple Pencil-Beam True Fan-Beam
(limited angle fan beam) CT-like design

Single detector 16 detectors 128 detectors

• Linear scanning
• Rectilinear scanning • Rectilinear scanning • High-resolution, dependent
• Resolution poor, • Resolution improved, on smaller detector size
determined by detector dependent on detector size • Single energy imaging
 The Truth Behind DXA Detectors

True Fan-Beam DXA GE LightSpeed CT

(Hologic)
• CT scanning geometry
• Same detection process
• Unique sampling - no overlap
• Short scan times
• High-resolution

photodiode
scintillator
 30 Second Scans – FALSE!!!!!
• 50 Second Spine
• 99 Second Hip
 Precision
• Precision – The ability to repeat a
measurement
• Important in calculating least significant
change –
– 1% precision = 2.8% change
– 2% precision = 5.6% change
• 1% is the industry's target
GE Precision Poster (ASBMR 2004)
• Compares the precision of the Prodigy versus the
QDR 4500 and Delphi.
• The results show significantly better precision on
the Prodigy than on discontinued Hologic systems.
• Biased GE Study
• Not Done at same facility with the same operator
and patients
 Summary of Precision
Author System Spine Precision Femur Precision
Nord 2003 DPX Bravo 1.2 0.8*
Blumenthal DPX Bravo 0.8 1.2
Average 1.0 1.0
Mazess Prodigy 1.2 0.8
Wilson Prodigy 1.6 0.94
Steel Prodigy 1.3 1.5
Lewiecki Prodigy 0.9 0.8
Average 1.25% 1.01
Nattrass Discovery 0.90 1.00
Laster Discovery 1.06 0.93
Average 0.98 0.96
 Prodigy One Scan

T=1.0 T=1.6
CADƒx
• Computer aided fracture
assessment
• Simplified IVA
interpretation
• Quantitative
confirmation of vertebral
deformities
• Displays degree of
vertebral compression
• Improves confidence in
interpretation
 Lunar’s CAD (Computer Aided
Densitometry)

• User Dependant
• Time Consuming
• Not Automatic
• QA Tool for Techs
• Not FX Assessment
 10 Year Fracture Risk
• Risk based reporting
• Hologic will adopt new WHO guidelines
• GE has jumped the gun. This will cause confusion in
the industry
• QDR Mobility sets the framework for risk reporting
• GE may claim they "patented absolute fracture risk“
(Hologic Patent 6385283 covers us)
 Competition
DMS – Norland - ACN
 DMS - Chronos
• Pencil Beam
• CZT detector
• Slow
• No imaging
• No Precision or Validation Studies?
• Most doctors want to sell it back after 1 year
DMS Lexxos
Pulsed X-ray Generator

Pyramidal Flash Beam

Flat Panel Detector

DMS Lexxos – Theoretical Advantages

• Speed (*****)
• Dose (*****)
• Resolution (*****)
• Precision (*****)
 DMS Lexxos – Reality?
• No positive study on precision (Spine @2,5% by G.Blake/UK?)
• Parallax problems with FVA
• Full Spine Imaging done with 2 images – poor stitching SW
• No Whole Body, no PH, no Fx assessment
• Array resolution ≠ Effective resolution
• Huge scatter on array (affecting precision and resolution)
• Increasing thickness drastically damages image quality, accuracy and precision
• Throughput similar to Discovery in 30sec - Usefullness of flat panel?
• Price of array replacement. Ouch!
• Now available in “light” and “compact” versions
• Who’s using it in clinical routine?
• Reference curves copied over from Holx however BMD don’t match
 DMS Lexxos – What to say?
• Ask for studies on precision
• Ask for studies on dose
• Ask today’s available features
• Ask comparative scans of the same patient
on Discovery and Lexxos. Differences can
be up to 20%
• Ask the price for array replacement
• Ask the names of luminaries
 Norland
• Nothing really new: XR-46 and Excell
• Low prices
• Pencil beam only
• No imaging
• No longer focussed on Osteoporosis, weak
marketing, no new development
ACN – Unigamma Plus
ACN – Unigamma Plus
 ACN – Unigamma Plus
Features
• CZT detector – 100 elements
• Linear acquisitions
• 30 second scan times
• <0,5% precision
• low dose 1mR Spine/Hip
• 20 sec calibration before every patient using patented internal
phantom
• Monthly calibration performed with external phantom
• Manufactured by an Italian company
 ACN – Unigamma Plus

What to think?
• Another new one in Osteoporosis testing
• How long will it last?
• Who’s using it? Validation studies? References Curves?
• Don’t be fooled by brochures and low prices only
 General Remarks
• Always keep in mind we’re selling a Top of the range balance – focus on BMD –
T-score is only a statistical consequence of BMD
• Dose is important but don’t mix “minimum” and “optimum” – Most important
point in diagnostic?
• Always use a financial analysis on 5 years (tube, #patients,...)
• Keep your respective SD’s updated with new products/selling strategies
• Patient’ compliance to IVA scan time? Breathhold during 3min?
• The truth about how to use a Prodigy? Watch this...
Questions?
 Product Positioning
Seven (7) models designed to meet different performance demands
• Explorer:
– 90 Second BMD with 10 Second Medium Resolution IVA
– Procedure Automation
– Optional Electronic Review and CADfx
• Discovery i series:
– Similar Features to Explorer
– 30 Second BMD with 10 Second Medium Resolution IVA
– Performance Level PC and Peripherals
• Discovery series:
– Similar features to Discover i
– 10 Second BMD with 10 Second High Resolution Imaging
– Standard Electronic Review and CADfx
 Product Positioning
Explorer vs. Prodigy
• Explorer • Prodigy
– 54 Detectors – 16 Detectors
– 16” Arm Clearance – 16” Arm Clearance
– Medium Resolution – Low Resolution
Imaging Imaging
– No Distortion – Overlap Distortion
– 90 Second BMD – 60-99 Second BMD
– Continuous Calibration – Daily Calibration
Explorer Should Compete Directly with Prodigy!
Ultrasound Bone Densitometry
Hologic Sahara Heel Ultrasound System

• 1st FDA Approved

• Radiation-free, portable
• Dry technology
• Light Weight (22 lbs.)
• Rapid assessment (<10 sec)
• Utility:
– Risk Assessment w/o DXA
– Screening for DXA
 Sahara cont.
• Uses Cutoff (-1.0) to Establish
Risk
• Heel 2nd
nd Best Predictor of Hip

FX Risk
• 80 - 90% of patients with hip
DXA T-Scores below -2.5 have
heel T-Scores below -1.0 1717
Central vs. Peripheral BMD Measurements
• Hip and spine the “Gold Standard” for BMD Diagnosis
• Hip and spine the “Gold Standard” for Monitoring of BMD
changes
• Peripheral measurements useful for risk assessment, but not
preferred
• Peripheral measurements NOT RECOMMENDED for
Monitoring of BMD changes
• BMD and Vertebral Assessment (IVA) is the standard of care
 Sahara Strengths
• Speed – 10 second measurement
• Size – Small, Portable Design
• Caliper for accurate heel width measurements
• Does not require computer
• No Water!
• BMD, SOS, BUA and QUI
• Easy to Use
• Hologic – Leader in Osteoporosis Assessment
 Competitors
• Lunar Achillies
– Water Membrane that Rupture
– No BMD
• DMS UBIS 5000
– Large System – Limits Portability
– Requires
– No BMD
• Norland CUBA
– Requires Computer
– No BMD
– No Heel Width
 Competitors
• Osteometer DTU-One
– 3 Minute Scan
– Requires Computer
– Large
• Quidel QUS 2
– 2 Minute Scan
– Moving Transducers
• Aloka AOS 100NW
– Requires Computer