Autoimmune Connective Tissue Disease Diagnostics Opportunities

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