The Food and Drug Administration (FDA) has approved Foundation Medicine’s liquid biopsy test. The test can be used as a companion diagnostic for FDA-approved precision therapies for treatment of prostate cancer and non-small cell lung cancer (NSCLC).
The use of the liquid biopsy, mutation detection from circulating tumour DNA (ctDNA), has been an area of active research. Obtaining sufficient tumour tissue for testing can be quite challenging, particularly when there is an insufficient biopsy sample and invasive procedures pose a health risk to the patients. For instance, approximately 27%-31% of NSCLC patients are unable to provide a suitable specimen upon diagnosis. The use of ctDNA is, therefore, a great minimally invasive alternative method.
With much enthusiasm regarding the development of noninvasive methods for mutation testing, the market for liquid biopsy is heating up. The FDA has also recently approved a Guardant Health diagnostic that combines two technologies, next-generation sequencing and liquid biopsy, in one test. Although Foundation Medicine and Guardant Health are the two biggest players in this rapidly growing market, GlobalData’s marketed products database estimates that there are over 40 other companies with products, specialising in liquid biopsy.
GlobalData predicts that there will be increased usage of liquid biopsy in the future. The cost efficiency and the minimally invasive aspect of the technique will be the biggest drivers of the market. However, the technique will not fully replace the tissue biopsy, which is set to remain the gold standard.
Overall, the companion diagnostics market took a hit as a result of the pandemic as most countries started restricting non-essential procedures and diagnosis. This included cancer tests and screening. However, the market is expected to recover and experience positive growth due to a surge in patients making up for missed tests.