What’s next for the early detection liquid biopsy sector?
The specialist was first asked about how the sector has evolved as a screening approach. In a sign that the Food and Drug Administration (FDA) is becoming more comfortable with liquid biopsies, “Foundation Medicine Test and Guardant360… were approved for both tumour profiling, as well as companion diagnostic claims”.
There has also been a “burst” in monitoring assays. “About five years ago everyone was talking about early cancer detection in asymptomatic patients, and that was the Holy Grail… but now we’re seeing this idea of early cancer detection after you’ve had cancer.”
The FDA and Centers for Medicaid and Medicare Services are both responsible for approving such technologies. Their different guidelines mean that “one of the problems that happens is that you’ll get FDA approval, but you won’t get reimbursement for your test”. However, “if you get breakthrough device designation during your interactions with the FDA you can qualify for reimbursement for two years after the approval to allow you to get the clinical utility data.”
Recent acquisitions within the industry were also on the agenda, including Illumina and Grail, the former of which is the leader in sequencing. In addition, Thrive was purchased by Exact Sciences, “and that was huge, because Exact Sciences, they had developed the Cologuard test so they had a ton of experience in early cancer detection”.
“I don’t think Illumina and Exact Sciences are done purchasing and acquiring companies that are like this. I think they’ll keep adding companies.” Strong candidates for future targets include those specialising in artificial intelligence (AI). “I think we’re going to see a lot of AI approaches to early cancer detection, and I think those companies could potentially be acquired, because to improve sensitivity and specificity you can expect that you need multi-modal approaches.”
To access all the human insights from Third Bridge Forum’s liquid biopsy early detection – multi-cancer screening Interview, click here to view the full transcript.
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