PointofCare Diagnostics: The Role of Clinical Utility

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Point-of-Care Diagnostics The Role of Clinical
Utility

• Matthew Gombrich, M.D., M.S.
• Director of Clinical Research
• Inverness Medical

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What this presentation wont do

• Discuss revenue potential
• Discuss details of future technologies
• Discuss new markets

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What this presentation will do

• Be self-promoting
• Be self congratulatory
• Most importantlymedicocentric.

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General Business Growth

• Business parameters (cheaper mouse-trap)
• Performance parameters (better mouse trap)
• RD (novel mouse trap)
• Clinical Utility (?)

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• Product development cannot be focused on the
  wishes and whims of Point of Care Coordinators,
  nurses, and physicians, but must be based upon
  the development of assays that provide
  actionable, clinically relevant information.
• The POC Testing Market, A Market With
  DirectionFrost Sullivan 2003

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A Pejorative Example

• Rapid Influenza Testing
• Tracked antibiotic prescribing in primary care
  M.D.s using rapid flu tests.
• 99 of flu test negative pts received
  antibiotics.

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What of flu test positive pt.s received
antibiotics?

• 86!

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Reasons stated for this trend

• Patient pressure.
• Concerns regarding sequential (super)
  infection.
• Otitis media
• Bronchitis
• Pneumonia

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Wheres the clinical Utility?

• Most patients presenting with influenza-like
  symptoms and are rapid tested are outside the
  48hr window for anti-virals.
• Clearly, many of these patients are receiving
  antibiotics regardless of rapid testing results.

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The Inverness Approach

• RD development with clinical utility.
• Ex. Influenza
• Creating/Expanding markets through outcome
  studies.
• Ex. Pneumococcus
• Looking to the future when rapid diagnostics
  plays a significant role in the
  direct-to-consumer market.
• PG joint venture

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Outcome Studies An example of reverse
engineering in the In-Vitro diagnostic world

• Adapting both market response and changes in
  clinical practice into future, post-market
  clinical research.

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A Little History

• Assay FDA approval 1999 for the urinary S.
  pneumo test for community acquired pneumonia
  (CAP).
• Clinical In 1999 (and before) CAP is treated
  empirically, without assessing the etiology of
  the pneumonia.
• Why?

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Community Acquired Pneumonia

• Epidemiology
• S. pneumo, H. flu, Mycoplasma pneumoniae,
  Chlamydia pneumoniae, Legionella pneumophila
• No accurate, rapid means to assess etiology
• Development of broad spectrum drugs
• Macrolides
• Emergence of penicillin-resistant pneumococcus
• Pressure from pharma

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The two arguments used against the Inverness UAT
for S. pneumo.

• Broad-spectrum drugs work
• 2. The test doesnt provide susceptibility
  results (i.e. how can I focus therapy without
  this information?)

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Hidden Epidemic of Macrolide-resistant
Pneumococci. Keith P. Klugman  and John R. Lonks

• Community-acquired respiratory tract infections
  (RTIs) account for a substantial proportion of
  outpatient antimicro- bial drug prescriptions
  worldwide. Concern over the emer- gence of
  multidrug resistance in pneumococci has largely
  been focused on penicillin-resistant
  Streptococcus pneumoniae. Macrolide antimicrobial
  drugs have been widely used to empirically treat
  community-acquired RTIs because of their efficacy
  in treating both common and atypical respiratory
  pathogens, including S. pneumoniae. However,
  increased macrolide use has been associated with
  a glob- al increase in pneumococcal resistance,
  which is leading to concern over the continued
  clinical efficacy of the macrolides to treat
  community-acquired RTIs. We provide an overview
  of macrolide-resistant S. pneumoniae and assess
  the impact of this resistance on the empiric
  treatment of community-acquired RTIs. Emerging
  Infectious Diseases ? www.cdc.gov/eid ? Vol. 11,
  No. 6, June 2005

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How Inverness Medical Approached this problem

• Detailed literature mining.
• Committed resources to network KOLs.
• Committed resources for outcome studies.

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What we found

• The literature did not support the clinical
  relevance of penicillin-resistant pneumococcus in
  CAP.
• The pressure from pharma regarding the use of
  broad-spectrum agents was greater than expected.
• The literature data regarding the use of the S.
  pneumo UAT was limited in the appropriate setting.

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Inverness Initiatives

• Lobbied the IDSA through informal relationships.
• Incorporated the available data into our sales
  training program.
• Initiated outcome studies to expand the
  application of the S. pneumo UAT.

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Outcome
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BinaxNOW S. pneumoniae Unit Sales Worldwide
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Outcome study

• Show clinical utility (i.e. focused therapy) in
  the outpatient CAP pt.
• Provide treating M.D.s the option of focused
  therapy.
• Expand market from 1M pts (US) to 5M pts (US)
  annually.
• Data for FDA submission regarding CLIA waiver.
• Expand the use of the test into primary care.

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Conclusion

• The evaluation of clinical value with regards to
  rapid diagnostics should not stop at the
  initiation of an RD project. The world of
  therapeutics is a constantly evolving entity, as
  is the thinking that goes into clinical decision
  making. Diagnostic companies need to nurture
  their relationship with this rapidly changing
  clinical environment, not only when developing
  new assays, but with regards to pre-existing
  tests as well.

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Back to the Mouse Trap Analogy

• What if we could build a mouse trap that was
• Inexpensive (Business parameter).
• Highly effective (Performance parameter).
• 3. Novel design (RD parameter).
• 4. Catches multiple mice, is humane, and lowers
  carbon footprint (Expanded Utility).