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Competitors • Luminex: Bio-Rad, Inova
(Werfen), Zeus (Alere), BMD (Bio Medical Diagnostics)
• Traditional: Phadia, Hycor • Mainframe (e.g., for RF,
CCP) • Specialty labs (RDL,
Crescendo)
Customers (products, commercial organization) • Sell to reference labs • Sell to specialty labs • Sell to doctors’ offices
Unique attribute? • Multiplex | array • Novel biomarkers • Combined genetics with
immunoassays
Strong Referral Pattern
5.8
5.3 5.2
4.8
4.5
3.9 3.8
3.7
2.2
4.6
5.9
3.7 3.8
5.4
4.3
3.8
5.4
3.3
Prognosis for progression
prior to erosive disease
Definitive Diagnosis
Prognosis for erosive disease
DMARD/biologics within
1 year of symptoms
Diagnosis before
symptoms
Treatment planning
Treatment monitoring
Rule out Screening
Relative Importance of Improved Ability
Adult Rheumatology Other Specialties
A Number of opportunities for “Diagnostic” Improvement in RA
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Abatacept
Adalimumab
Anakinra
Belimumab
Certollizumab
Entanercept*
Glomumab
Infliximab
Rituximab
Tocilizumab
Tofacitinib
Uztekinumab
Many Biologic or Novel Therapeutics for CTDs Opportunities for a number of companion diagnostics
Nominal value and volume • RF currently 115 million tests annually worldwide • CCP 20 million tests annually worldwide • Other autoantibody 100 million tests worldwide • Prevalence of connective tissue disease 1 to 2% or 3 to 6 million in US • Prevalence of RA in the US 0.5% or more than 1.6 million • Prevalence of osteoarthritis in the US is 15% of ≥25 years old or ≈ 30 million • Potential of $200 to 500 million in US for value-added markers | panels beyond current
indications Indications for use Current • Aid in the diagnosis of … New / inflection indications • Therapeutic monitoring • Screening of first degree relatives • Prognosis of patients with undifferentiated arthritis • Prediction of erosive disease • Diagnosis and prognosis of mixed connetcive tissue disease
© 2013 Winton Gibbons
Testing sites • Mainstream reference labs
(e.g., Quest, LabCorp, ARUP, Mayo)
• Specialty labs (RDL, TheraTest, Crescendo)
• Local hospital • Doctor’s office
Source: AHRQ, NCHS, Market research
Market (menu varies) • Mainstream reference labs (e.g., Quest, LabCorp, ARUP,
May) • Co-morbidity: 2x non-Hodgkin’s lymphoma,
Cardiovascular, other autoimmune, e.g., celiac in 5-10% of autoimmune
• Local hospital • Doctor’s office
*AHRQ study suggest has higher probablity of improvement based on meta-analysis
Diagnosis can Improve and be more Efficient
Opportunities for Multiplexing