
A new kind of liquid biopsy
Several liquid biopsies are available in the US, but until today they all worked by detecting DNA shed by solid tumours into the blood. Now they are joined by a different approach: Angle’s Parsortix system sieves entire cancer cells out of a blood sample so that researchers can analyse them for clues to the best treatment decisions. The device today received de novo clearance for use in patients with breast cancer – the third blood test to be FDA-regulated, and the first for this specific indication. Angle says this is the first de novo clearance for a new instrument in oncology “for many years”. Five years ago Angle said the Parsortix instrument costs around £40,000 ($52,000), with the single-use cassettes needed to analyse samples going for around £100 – but this was in Europe, and for research rather than clinical use. How the system will be priced in the US is not yet clear, though Angle said that per test, Parsortix would be “substantially cheaper” than the average cost of a breast cancer tissue biopsy – $16,000 in the US. Payers will take a keen interest in how the Parsortix price compares with the other liquid biopsies on the market.
The liquid biopsies available in the US | ||||
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Company | Liquid biopsy | Tumour type | Intended use | Status |
Guardant Health | Guardant360 | Pan-cancer | Helps assign targeted therapy | Approved in US Aug 7, 2020, price approx $6,800 |
Shield | Colorectal | Screening | Launched as LDT May 2, 2022 | |
Reveal | Colorectal | Postsurgical, detects disease recurrence | Launched as LDT Feb 16, 2021 | |
Roche | FoundationOne Liquid CDx | Pan-cancer | Helps assign targeted therapy | Approved in US Aug 27, 2020, price $5,800 |
Illumina | Galleri | Pan-cancer | Screening and identification of tumour origin | Launched as LDT Jun 4, 2021, price $949 |
Natera | Signatera | Pan-cancer | Postsurgical, detects disease recurrence | Launched as LDT Aug 21, 2017 |
Angle | Parsortix | Breast | Harvests tumour cells from blood for analysis, including therapy guidance | Approved in US May 25, 2022 |
LDT = lab-developed test. Source: Evaluate Medtech & company websites. |