Market Considerations and Segmentation Slides - AACC
Transcript of Market Considerations and Segmentation Slides - AACC
Molecular Diagnostics
Mike NugentGlobal Market Segment DirectorBD Molecular Diagnostics/BD MAX
B.A Life ScienceMBA – Robert Smith School, U of MD
Pace of change in growth based microbiology has been slow over time…• Blood plate invented 1881• Blood plate commercially
available 1950’s• Incubators• Microscopes• Reagents
Although innovation has been accelerating in the last 10 years:
Maldi TofMicrobiology Lab automation
(Kiestra, WASP)
Molecular diagnostics landscape on the other hand…
Many changes in the 31 years since PCR was first developed…
1983 – PCR invented
2014
Separate Rooms
Single room
Singleplex/tube 20+ Multiplexing
Isothermal methods
Sample to
answerMultiple instrumentssystems required
Single instrumentamplificationdetection
These rapid changes in molecular diagnostics technologies are creating several market forces that will fuel growth in the future
Automation and multiplexing simplifying workflows
Conversion from conventional to
molecular diagnostics
Decreasing costs making molecular testing more affordable
Shift toward syndromic panels
• Accessibility• Molecular
available to the masses
• Laboratory labor relief
• Clinician benefits
MDX outlook by diagnostic area looks very strong in the near term and beyond…
Virology
5.3
BloodScreening
+7.6%
4%
20%
30%
22%
Oncology
Microbiology
12%
9%
2012
8%
5%
22%
27%
25%
7.6
2017
Other
Histology
15%
Other includes: Prenatal, Coagulation, Tissue Typing, Oncology, CTC, Pharmacodiagnostic
Molecular Diagnostics market forecastUSD Billion
Multiple areas for growth exist in the broad WW Molecular Diagnostics market
• Molecular Diagnostics WW is anticipated to grow from a $6.1B market in 2014 to over $10B in 2024
• The largest areas of growth in this time period are Histology/Cancer Diagnostics and Infectious Disease Diagnostics.
• Infectious Disease Diagnostics is expected to see a CAGR of 9.4% over the next 3 years.
US and Europe remain the biggest users of MDX technologies, but emerging markets are growing quickly…
Clinical Molecular testing remains a phenomenon of the developed world
US dominates the molecular market: - Centralization and rationalization of testing
Europe continuing healthcare reforms- Economical pressures result in centralization of diagnostic labs and testing rationing
China 2nd largest laboratory market in Asia:- Fastest growing IVD market for modern lab instrumentation and tests and primary care tests and
devices
India rapidly growing diagnostic lab segment:- Driven by the demand from the private health sector and hospital are upgrading services
Questions that manufacturers should consider for assay development
Will the assay change/impact
therapeutic decision?
Is there a significant lab benefit:
Time/Labor/Materials?
Will the technology increase accuracy or
detection?What is the cost
position for the assay?
What is the disease prevalence?
BD’s vision for molecular testing is built to address the most critical clinical issues using intelligent assay design
…leading to flexible, cost effective diagnostic tools that impact clinical outcomes
Evolving clinical and patients challenges (emerging diseases, cost, time to result)
Technical Capabilities
(Instrumentation and molecular chemistry)
Laboratory requirements (accuracy,
productivity, efficiency)
Smart assay design is a patient centric approach to assay development…
• Focused panels• Multiplex assays• Open System Reagents
Syndromic approach based on:• Patient and clinical
consideration• Disease prevalance• Test methods tailored to the
patient
Hospital based laboratories today are faced with unprecedented internal and external pressures…
…forcing them to identify approaches to diagnostics solutions…
REGIONAL LABS
REGIONAL LABS
REGIONAL LABS
Clinicianexpectations
Challengingnew
pathogens
Reduction in
SkilledLabor
Time and Space
Constraints
Molecular testing for enterics
Study Design – Examine cost and turn around time for conventional methodologies for 206 stool cultures
•Costs of all media and tests•Time required (Labor) for processing•10 consecutive days / 5 MTs of varying levels of expertise
•TAT from time received to time finalizedConclusion Summary ‐ Costs associated with conventional testing are substantial when considering time to result and labor requirements.
•Cost of finding a positive is $427 due to the low prevalence and amount of labor and false positivework ups.•63% of negative stool cultures require additional testing beyond primary media.
•Time required by MTs working up stool cultures limits time spend on more complex, higher value diagnostic tests.
•Time to result varies from 48 hours to 96 hours
ASM 2013 Abstract … Quantifying Stool Culture Costs and Time to Results
Beal et al, ASM 2013 Denver, CO USA
Cost Tables:
Total Cost / Stool w STEC Screen 24.86$
Media and Labor Supplemental Tests
* STEC EIA not performed in Lab during this study
Review of cost calculations … STEC screening added to analysis
Total Cost / Stool 9.86$
Cost :MacConkey 0.21$ XLD 0.28$ Sheep Blood Agar 0.18$ Campy Agar + pouch 4.37$ Selenite Broth 0.43$ XLD from Selenite Broth 0.28$
5.75$ STEC EIA* 15.00$
Labor per stool (8 min / $27 per hr) 3.06$
Labor & Media Cost per stool 8.81$
# of tests Cost (ea) Total CostOxidase 58 0.05$ 2.90$ Gram Stain 54 0.80$ 43.20$ Restreak to BAP 52 0.18$ 9.36$ Wet Prep 35 0.50$ 17.50$ TSI 31 0.41$ 12.71$ LIA 29 0.44$ 12.76$ Restreak to MAC 15 0.21$ 3.15$ Spot Indole 15 0.05$ 0.75$ ID/AST 14 3.95$ 55.30$ Vanc Screen Agar 7 0.90$ 6.30$ MDG 6 4.51$ 27.06$ StrepQuick Card 4 4.80$ 19.20$ Restreak to XLD 3 0.28$ 0.84$ PYR 3 1.50$ 4.50$ Catalase 2 ‐$ ‐$ Total (206 stools) 215.53$
Cost / stool 1.05$
Beale et al, ASM 2013 Denver, CO USA
We have developed a differentiated menu that will enable transition to molecular based diagnostic solutions
Enteric Assay Example
… To rapid, accurate molecular diagnostics
Sample received by lab - culture setup
Incubate 35o/2 days
Incubate 35o/1 day
Incubate 42o/3 days
Incubate 25o/2 days
24 hours 48 hours 72+ hours
Sample received by lab - BD MAX setup
2 hours
Sample in tube load MAX
• Test for E. coli• Re incubate 24 hr• Plate review• Subculture suspect colonies
• Plate review• Subculture suspect colonies
• Screen for Campy• Incubate Campy 24 hr
From conventional culture based methods…
15
Sample Preparation
1. Vortex unpreserved or Cary-Blair preserved samples at high speed for 15 seconds.
2. Remove the clear cap from the SBT and inoculate as follows:
a. Insert a 10 μL disposable inoculation loop until the entire loop portion is submerged in the sample.
3. Place the SBT in a rack compatible with a multi-tube vortex mixer.
4. Add inoculated SBT to BD MAX rack.
• Proceed to MAX:1. Remove the required number of URS(s), Extraction
Tube(s) and Master Mix Tube(s) from their protective pouches from the BD MAX Enteric Bacterial Panel kit.
2. For each sample to be tested, place one (1) URS on the BD MAX System Rack and snap 1 Extraction Tube and (1) Master Mix Tube) into each URS.
3. Add the required PCR Cartridges to MAX4. Start Run.
BD MAX ENTERIC BACTERIAL WORKFLOW
• Highlights:• 4242 diarrheal stool samples
(3457 Prospective / 785 Retrospective)
• Reference Method – Culture and Shiga‐toxin EIA
• Discordant analysis – Alt PCR and Sequencing
• Total run time of the EBP including sample processing, PCR, and result reporting is 2h 35 min.
16Mortensen et al, ECCMID 2014 Barcelona, Spain*Table presented at BD Meet the Experts ECCMID
Data Summary (Post-discrepant analysis)*
Multiple other areas where Molecular Diagnostics can be implemented for efficiency, accuracy
• Antibiotic Resistance Marker detection– CRE– ESBL– MRSA
• Other instances where culture based methods are either lower yield or labor intensive– Cdiff
• Low prevalence disease areas– Open System reagents for specific analytes
Thank You