Health Care & Insurance March 25, 2020 8:41:18 pm

Japanese regulators approve ArcherDX lung-cancer test for joint treatment

By Lucas High

BOULDER — Drug regulators in Japan have cleared genetic disease testing company ArcherDX Inc. and development partner Merck KGaA to sell a combination of tests and treatments for small-cell lung cancer in the country.

In a statement Wednesday morning, ArcherDX said its test can be used to determine if specific genes in a patient have mutated and are sending out signals to cells to develop forms of lung cancer that are recurring or can’t be removed through surgery. It is approved in conjunction with Merck’s tepotinib, which is thought to inhibit those cancer-growing signals.

The companies estimate 3 percent to 5 percent of all lung-cancer cases worldwide could be treated by the specific genetic mutation detected and treated by the test and tepotinib.

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ArcherDX formed the development partnership with Merck KGaA in 2018, and the U.S. Food and Drug Administration granted breakthrough therapy status to tepotinib last September.

Merck KGaA is the German originator of the drugmaker’s name, while Merck and Co. Inc. (NYSE: MRK) was originally its American subsidiary. The two companies are operationally separate despite sharing similar names.

ArcherDX has been one of the most active fundraising startups in the Boulder Valley as of late, raising $115 million in Series B and Series C rounds last year. Venture capital analysis firm Pitchbook said the most recent funding round in December places the company’s overall value at $255 million.