Grail’s liquid biopsy today became the third pan-cancer blood test to be launched in the US. But it is being sold for a slightly different use versus the two approved tests. Galleri, which is not approved by the FDA but sold under a Clia waiver, is on sale as a screen, and can be used to test people aged over 50 at elevated risk of cancer. The other two tumour-agnostic liquid biopsies are used in patients who already have a confirmed cancer diagnosis, as a way to assess the mutations a tumour carries and therefore help assign targeted drugs. Grail is pitching its Galleri test at $949, quite a bit cheaper than both its rivals: Roche’s FoundationOne Liquid CDx sells at $5,800 and Guardant’s Guardant360 around $1,000 more than that. But the latter two have formal FDA approval, granted last August, making reimbursement easier – no reimbursement is yet in place for Galleri. Meanwhile Illumina’s $8bn bid to acquire Grail is no nearer closing. The FTC recently withdrew a lawsuit seeking to block the acquisition, which sounds like good news, but is in fact the opposite. The suit will likely be refiled later, delaying the deal's close further.
| Selected pan-cancer liquid biopsies – progress update | ||||
|---|---|---|---|---|
| Company | Liquid biopsy | Use | Status in US | Company notes |
| Guardant Health | Guardant360 | Helps assign targeted therapy | Approved Aug 7, 2020, price approx $6,800 | $550m VC funding; floated in 2018 |
| Foundation Medicine (Roche) | FoundationOne Liquid CDx | Helps assign targeted therapy | Approved Aug 27, 2020, price $5,800 | $115m VC funding; bought by Roche for $2.5bn in 2015 |
| Grail | Galleri | Screening for early detection and identification of tumour origin | Launched as LDT Jun 4, 2021, price $949 | $2.1bn VC funding; bought by Illumina for $8bn in 2020 |
| Unnamed | Postsurgical, detects disease recurrence | In development | ||
| Thrive Earlier Detection (Exact Sciences) | CancerSeek | Early detection | FDA breakthrough device status | $367m VC funding; bought by Exact Sciences in 2020 for $1.7bn |
| Natera | Signatera | Postsurgical, detects disease recurrence | FDA breakthrough device status | $152m in VC funding; floated in 2015 |
| Archer DX (Invitae) | Stratafide | Helps assign targeted therapy | FDA breakthrough device status | $150m VC funding; bought by Invitae in 2020 for $1.4bn |
| LDT = lab-developed test. Source: EvaluateMedTech & company websites. https://www.evaluate.com/vantage/articles/news/snippets/grail-launches-pan-cancer-screen-those-who-can-pay-out-pocket | ||||
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.