Specialist
Senior executive at Boudicca Dx LLC
Agenda
- Blood-based, multi-cancer screening competitive landscape and key players’ positioning focusing on Thrive Earlier Detection and Grail
- Impact of M&A activity from Illumina and Exact Sciences
- Strategies assessment
- Shortfalls of multi-cancer screening approaches and ongoing efforts to mitigate these shortfalls
- Reimbursement, regulatory dynamics and 2021 outlook
Questions
1.
Could you highlight any recent developments in the multi-cancer screening space over the last 6-12 months?
2.
How would you say liquid biopsy as a screen approach has evolved, and what has driven its increase in popularity?
3.
How would you compare multi-cancer screening approaches to MRD [minimal residual disease] testing and other specific tumour approaches?
4.
What are the main factors that would drive utilisation of multi-cancer screening tests?
5.
You mentioned a potential approval for early detection liquid biopsy assays within the next couple of years. Could you expand on the FDA and CMS guidelines for approval?
6.
Who would you say is leading in early detection multi-cancer screening now, and who would you expect to be the leader in 10 years from now?
7.
How would you assess Delphi Diagnostics’ approach and do you expect it to become a threat to Grail and Thrive any time in the future?
8.
Grail plans on debuting its Galleri multi-cancer blood test in Q2 2021. What are your thoughts on this platform and do you have any expectations for its sensitivity and specificity?
9.
Illumina has announced plans to set up its cancer detection efforts by launching a pan-cancer IVD [in vitro diagnostics] test. What value do you think this could add to its TruSight oncology platform, and how does this assay compare to any other genomic profiling assays?
10.
Now that Grail and Thrive have been acquired, which other companies would make sense as potential targets for other companies trying to enter the market?
11.
What additional capabilities do you think Illumina and Exact would need?
12.
What are the major shortfalls with multi-cancer screening tests and what has changed since our previous Interview [see Pan-cancer Blood Screenings – Thrive Earlier Detection & Grail – 18 August 2020]?
13.
How might the FDA compare a pan-cancer test vs a specific test? If a pan-cancer test has 85% sensitivity to ovarian cancer and a subsequent test is developed that has a 90% sensitivity for only tests for ovarian, how would the FDA perceive that discrepancy?
14.
In our previous Interview you mentioned that for pan-cancer testing, there is a question of what to do next after a positive result. Can you elaborate on this and how it is has developed since we last spoke?
15.
Would the FDA prefer a pan-cancer test with good sensitivity to many cancers or a host of separate tests that have all slightly better sensitivity, especially when it comes to asymptomatic patients?
16.
Do you have anything else to mention or could you summarise your 5-10 year outlook for the market?
