
Haystack and a needle: a look at the smaller liquid biopsy developers
With yesterday's data on Guardant's colorectal cancer screening liquid biopsy disappointing, it is worth looking at the smaller players in the cancer blood test segment. A new one of these, Haystack Oncology, emerged last month with an impressive $56m series A round. The group is working on a test for minimal residual disease – recurrent cancer caused by cells left after tumour resection. It is not alone among smaller developers in pursuing this setting; C2i Genomics, Burning Rock, Neogenomics and Invitae also have MRD tests. Otherwise the private groups are largely geared towards screening for individual cancers, whereas the smaller listed firms are working on tumour-agnostic screens as well as other settings, such as monitoring response to treatment. But there are perils here. The only one of these smaller companies to have gained FDA approval for a liquid biopsy is Epigenomics, which suffered badly after its test was denied reimbursement – at one point it looked like it would have trouble continuing. However, after a few rounds of refinancing it is now working on a new version of its colorectal cancer screen. The tables below are divided into private, venture funded groups and smaller listed companies.
Selected liquid biopsies from private developers | ||||
---|---|---|---|---|
Company | Liquid biopsy | Tumour type | Intended use | Status |
Haystack Oncology | Unnamed | Multi-cancer | Postsurgical, detects disease recurrence | Launch planned 2023 |
C2i Genomics | C2inform | Multi-cancer | Postsurgical, detects disease recurrence | Approved in Europe Apr 2022 |
Delfi Diagnostics | Unnamed | Lung | Screening | Launch as LDT expected 2023; approval approx 2026 |
Unnamed | Other single cancers | Screening | In development | |
Unnamed | Other single cancers | Monitoring | In development | |
Unnamed | Multi-cancer | Screening | In development | |
Freenome | Unnamed | Colorectal | Screening | Pre-empt CRC trial to report 2023 |
Unnamed | Lung, pancreatic | Screening | Vallania trial to report 2024 | |
Laboratory for Advanced Medicine | IvyGene Liver | Liver cancer | Screening | In development |
LDT = lab-developed test. Source: Evaluate Medtech & company websites. |
Selected liquid biopsies from smaller public developers | ||||
---|---|---|---|---|
Company | Liquid biopsy | Tumour type | Intended use | Status |
Angle | Parsortix | Breast | Harvests tumour cells from blood for analysis | Approved in US May 25, 2022 |
Parsortix | Ovarian | Diagnoses malignance in patients with pelvic mass | Ember trial hit Sep 2022 | |
Epigenomics | Epi ProColon | Colorectal cancer | Screening | FDA approved 2016; Medicare coverage denied Jan 2021 |
Next-Gen | Colorectal cancer | Screening | CRC-Draw trial to report 2024 | |
Invitae | Stratafide | Multi-cancer | Helps assign targeted therapy | FDA breakthrough device status |
Unnamed | Colorectal, bladder, lung | Postsurgical, detects disease recurrence | Maria trial to report 2026 | |
Burning Rock | OverC | Multi-cancer | Screening | Approved in Europe Jun 2022 |
brProphet | Multi-cancer | Postsurgical, detects disease recurrence | Launch expected 2022 | |
ELSA-seq | 6 tumour types | Screening and identification of tumour origin | Thunder trial hit Nov 2020; launch expected 2023 | |
Unnamed | 9 tumour types | Screening | Predict trial to report 2022-3 | |
Unnamed | 22 tumour types | Screening | Prescient trial to report 2024 | |
Biocartis | Idylla ctEGFR | Multi-cancer | Helps assign targeted therapy | On sale |
Oncimmune | EarlyCDT Lung | Lung cancer | Screening | On sale |
EarlyCDT Liver | Liver cancer | Screening | In development | |
Genetron | HCCscreen | Liver cancer | Screening | In development |
Oncocyte | DetermaCNI | Multi-cancer | Helps assign targeted therapy | In development |
Note: listed companies with market cap under $1bn. LDT = lab-developed test. Source: Evaluate Medtech & company websites. |