Exai develops RNA-based liquid biopsies to diagnose and monitor tumor progression.
In Summary: Given Exai’s success in demonstrating strong results in using oncRNA to predict tumor progression and size in breast cancer, the anticipated improvements for liquid biopsy technologies, the large and growing liquid biopsy market, Exai seems to be a leader in the space and is poised for future success.
Based off of work from Hani Goodarzi’s lab, Exai uses differential RNA profiling of tumor vs. normal tissue to train AI models to predict cancer prevalence. I especially like this company because fundamentally the technology encompasses a large amount of data: the circulating RNA exosome.
Exai is initially tackling Breast Cancer detection and monitoring of longitudinal outcomes. The liquid biopsy test was used in the clinical trial I-SPY2, which tested different drug treatments in an adaptive randomization clinical trial design. The test was used longitudinally to check for the ability to predict tumor size and progression based on oncRNA expression.
Exai’s model had predictive power for predicting the risk score, tumor volume, T-stage of the tumor (early to late stage), and RCB Class (indicating tumor burden following drug treatment but before surgery). Source
Additionally, classifying patient populations by risk determined by the oncRNA predicted risk score was able to indicate longitudinal outcomes. Source
Importantly, this first AI model for predicting tumor size was trained on 719 tumor biopsies. This seems scalable to other tumor types, and additionally there is room to improve these models as clinical databases of tumor sequencing grow and AI modeling techniques improve, or to train on different patient subpopulations if there is any indication of population genomics on ctRNA tumor expression. Exai’s success in I-SPY2 and clear potential for expanding into different cancer subtypes is a great sign.
Most of the liquid biopsy market is focused on ctDNA. According to Daniel Kim from UCSC, existing liquid biopsy tests are not as good at detecting early-stage cancers as they are for late-stage cancers, missing up to 75% of stage 1. (link)
Based on Biotech Careers, there are 4 other non-stealth liquid biopsy companies focused on RNA. Flomics has just raised their seed round of €1.1M in 2024 and doesn’t have any technical or clinical publications yet. Genemo (which has taken the url rnadiagnostics.com) comes from Sheng Zhong’s lab at UCSD. Genemo has participated in 2 clinical trials in predicting development of Alzheimer’s disease, but their last news/publication was in 2020. MiRNAX Biosens is a Spain-based company that seems to work primarily on COVID-19 diagnostics but states is has a UK-approved early Alzheimer’s detection kit, but I can’t find much on that past 2019. Superfluid DX, based in SF, is also tackling RNA detection for Alzheimer’s Disease, and seems to be primarily growing on the work of a 2020 cf-mRNA detection paper for AD from Stephen Quake’s lab (he is a scientific advisor of the company). The company was originally formed in 2014 as Molecular Stethoscope, but rebranded as Superfluid Diagnostics with its Series A raise.
The two competitors in the space that I can find news on: Genemo and Superfluid DX, are both working towards early detection of Alzheimer’s Disease, which is an incredibly challenging problem. Exai’s approach for detection and patient stratification of breast cancer based on RNA liquid biopsy already has strong results, and they’re poised to be a leader in the space.
The liquid biopsy market size is expected to grow at about a 11.6% CAGR over the next decade. According to Nova One Advisor, the market size will grow from $10.85B in 2023 to $32.54B in 2033 at a 11.61% CAGR. Early screening, where Exai has demonstrated potential, is expected to grow the fastest of the application subsections at a CAGR of 12.44%. (link, NovaOne) This is more rapid than the broader cancer therapeutics market of 9.20% CAGR from 2022 to 2032. (link, Precedence Research)
On the revenue side, MarketsandMarkets expects revenues to grow from $6.4B in 2024 to $11.3B in 2029 at a 11.9% CAGR. They also mention that liquid biopsy gives an advantage over traditional methods because it is minimally invasive, and allows hospitals to save precious tissue samples for immunoprecipitation or alternative methods for studying. ([link](https://www.prnewswire.com/news-releases/liquid-biopsy-market-worth-11-3-billion--marketsandmarkets-302139796.html#:~:text=CHICAGO%2C May 8%2C 2024 %2Fnew report by MarketsandMarkets™.), MarketsandMarkets)
However, the liquid biopsy market famously has a hard time getting insurance providers to pay for diagnostic liquid biopsies (link). However, there is momentum for life insurers to pay for it, as early detection of cancer means more spend on life insurance (link) (due to the higher likelihood of survival at earlier stages of detection). There is still a great economic drive for liquid biopsies for earlier detection of cancer - it is cheaper and easier to take care of early stage cancers than later ones, but the market and policy scaffolding to support this has not fully materialized. (link)
