Chinese regulators have approved Amoy Diagnostics’ EGFR mutation liquid biopsy. The regulatory nod marks the first time the China Food and Drug Administration (CFDA) has cleared a plasma-based EGFR mutation companion diagnostic for use.
Traditionally, doctors identified the non-small cell lung cancer patients most likely to respond to EGFR inhibitors such as Iressa and Tarceva by taking and analyzing tumor samples. The invasiveness of this procedure—and inability to get samples from some patients—led test makers to work on diagnostics capable of identifying EGFR gene mutations in plasma samples through the detection of circulating tumor DNA.
Amoy established itself in the nascent field by picking up a CE mark for its EGFR test. And it has now followed up with an approval that clears it to bring the benefits of liquid biopsies to patients in its home country of China.
“The development of liquid biopsy-based diagnostics in non-small cell lung cancer will transform the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions will benefit a lot to physician and patient,” Guangdong General Hospital’s Yi-long Wu said in a statement.
CFDA opened the door to the use of blood-based diagnostics in the identification of patients with the EGFR mutation in 2015 when it revised the label for gefitinib, an EGFR inhibitor sold by AstraZeneca as Iressa. The updated label cleared doctors to identify the mutation in blood samples when they are unable to access tissues for analysis.
The approval of such a test comes 18 months after the U.S. FDA cleared a liquid biopsy for use for the first time. That earlier approval involved another EGFR diagnostic, Roche’s cobas EGFR Mutation Test v2.
In securing an approval shortly after Roche did, Xiamen-based Amoy has burnished its reputation as a leader in the Chinese cancer diagnostics sector. That reputation is built on a series of agreements Amoy has struck over the past decade with companies including AstraZeneca, Merck KGaA and Pfizer.
Amoy pulled off an IPO on the Shenzhen Stock Exchange last year. Since listing, Amoy’s stock price has risen, and its market cap now sits above $1 billion.