Market Development Strategy IVD Hematological Oncology Assay

Reina Karunaratne

Global IVD Marketing Professional

January 19th, 2017

Scope of discussion

Task:Develop a market development strategy for an IVD version of a hematological oncology assay

Includes:1. List of target markets2. Barriers to adoption 3. Market development strategies to overcome barriers

Limitations:30 mins10 slides or less

List of Target Markets

Large Reference Labs

• LabCorp

• Quest Diagnostics

• Mayo

Specialty LDT Labs

• Foundation Medicine

• Genomic Health

Large Academic Centers

• John Hopkins

• UCLA

Cancer Centers

• MD Anderson

• Dana Farber

Integrated Delivery/Hospital

Network

• Kaiser

• Partners

• 80% of testing volume done by 20% of labs• Running large comprehensive cancer panel• Will be impacted by FDA regulations on LDTs

Disintermediation from send out methods

Internal genomic capabilities being developed due to:• Loss of revenue for hospital • Competitive and differentiated offerings• Recruitment of next generation oncologist

Target Customers: • Molecular pathologist

• hematopathologist• Lab director

Top Barriers to Clinical Adoption of NGS

Pairing with the right clinical trial

Standardization on clinical utility and reporting

Payer coverage/ Reimbursement

Proprietary variant databases

Pairing with the right clinical trial

Approaches and considerations:

• Getting into a clinical trial that targets our gene panel– Ex: MATCH- NCI

• Completing a pharma pipeline analysis for future drug target biomarkers

• Partnering with the KOLs driving the guidelines for standard of care– NCCN, ASCO, ESMO

Different standards for assessing clinical utility and NGS reporting

Approaches and considerations:

• Partnering with groups such as the Association for Molecular Pathology (AMP) that have taken positions on how clinical utility or reporting should be defined

• Form working groups of experts to establish standards for evidence based clinical coverage, reporting, and reimbursement rates

• Collaborate with pharma on top oncology molecular profiles for diagnostic, prognostic, therapeutic, and minimal residual disease utility studies

Payer refusal for coverage due to unclear patient management

Approaches and considerations:• Consulting with a reimbursement specialists on developing and executing

a strategy for coverage with major health insurance companies and government funding (Ex: Aetna, United, Anthem, Medicare)

• Establish a clinical oncology NGS patient management peer network/board with both laboratory professionals and oncologists with a goal of NGS patient management protocols

• Partner with initiatives that engage payers – Targeted Agent and Molecular Profiling Registry (TAPUR)– Molecular Evidence Development Consortium (MED-C)

Proprietary variant databases and refusal to share

Approaches and considerations:

• Incentivizing data sharing with existing Illumina customer base via greater value add-ons including database/informatics offerings

• Selecting and supporting the industry’s leading public repository relevant to clinical oncology (ex: ClinVar)

• Partner with data sharing initiatives (Ex: Global Alliance for Genomics and Health )– Seek board of director positions with these influential groups– Support education webinars on the importance of data sharing to collectively cure

disease

• Partnering with government lobbyist on The Precision Medicine Initiative

Conclusions

Target Markets:• Opportunity to introduce entry level panels to large

reference and specialty labs• Disintermediation from send out methods in

institutions that are seeing the patients

Barriers to overcome:• Pairing with the right clinical trial • Standardization on clinical utility and reporting• Payer coverage/ Reimbursement• Proprietary variant databases

THA

NK

YOU