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.

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