Liquid biopsy is the new big thing in my portfolio. 13.32% of my portfolio is invested in stocks which are related to this new technology.

Problem

Timely detection of cancer is critical for curing patients. Current methods for screening are often invasive and expensive. However, thanks to the advance of sequencing technologies, the possibility to detect cancer from a simple blood test.

Solution

When a cell dies, its genomic content gets released in the body and occasionally enter the blood stream taking the name of circulating cell-free DNA. Genomic of dying cancer cells will carry mutations that are not present in the other cells. Therefore, scientist started to study the circulating cell-free DNA with two key goals:

1. Guide personalized treatment based on the cancer subtype and mutations identified and study the progress of the disease. This substitute the need of performing multiple invasive tumour biopsies.

2. Detect the presence of cancerogenic mutations in the circulating cell free DNA from blood collection.

Key players

On August 7 2020, Guardant Health ($GH) was the first company receiving FDA approval for liquid biopsy next-generation sequencing companion diagnostic test, opening a new era in oncology. With this technology is now possible to detect a list of cancer biomarkers from a simple blood test, that can be used to provide better treatment for the patient with lung cancer.

Just a few days after, on August 28th Roche announces FDA approval of FoundationOne Liquid CDx, a comprehensive pan-tumour liquid biopsy test. Many cancer patients are unable to have a tissue biopsy. FoundationOne Liquid CDx may provide a minimally-invasive option for patients who otherwise might not have benefitted from comprehensive genomic profiling.

Grail is spin-off of Illumina and recently acquired back. Their goal is to use liquid biopsy to detect cancer in early stage. Grail’s test, called Galleri, can detect more than 50 types of cancer with a false positive rate below 1%. Galleri is currently in clinical trial, if successful it can reach the market in 2021.

In September 2020, At the Cowen Liquid Biopsy Summit, Exact Science (EXAS) said its test detected six cancer types with 86% overall sensitivity and 95% specificity. The data suggest Exact Sciences has a shot at competing with the likes of Grail and Guardant Health for the liquid biopsy market, although management acknowledged it still has “a ton of work” to do.

Market opportunity

The bullish expectation for liquid biopsy market size for cancer detection in US alone is from $200–400 billion USD. If proved successful, everyone above certain age in developed countries will undergo regular screening with liquid biopsy. Furthermore, the low cost will improve the cancer diagnostic capability of low-income countries.

Today liquid biopsy market size is below $5 billion USD and combined market cap of $ILMN $EXAS and $GH is still relatively small. Analyst predicted that global liquid biopsy market size will grow at > 30% CAGR, that’s a lot more than $SPX500.

Limitations

– Doctors are worried that people undergoing blood-test screening might skip other screening which are more precise.

– Still few applications have been approved by FDA. More testing is required before we can have a better understanding of its precision.

This is an evolving field, and I will keep my portfolio updated based on the recent progresses in liquid biopsy. If you would like to join me, and invest together on this revolutionary technology, you can think about copying my trades on eToro by joining with this link https://etoro.tw/390fuwe and copy my profile SimoneRizzetto88.

References

FDA approves Guardant360CDx https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test

Roche announces FDA approval of FoundationOne https://www.roche.com/media/releases/med-cor-2020-08-28.htm

A recent review publish on Nature https://www.nature.com/articles/s41576-018-0071-5

List of Grail publications https://grail.com/science/publications/

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