Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. has had its hopes of entering the U.S. market dashed yet again following a second decision from the FDA that Febridx has not demonstrated substantial equivalence to the predicate device identified in its 510(k) application.
Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Pty. Ltd. saw its stock plummet 65% on the news that the U.S. FDA rejected its Febridx 510(k) because the device was not substantially equivalent to the predicate device.
PERTH, Australia – Rapid point-of-care (POC) diagnostics company Lumos Diagnostics Holdings Ltd. completed a A$63 million (US$47.44 million) initial public offering (IPO) on the Australian Securities Exchange (ASX) on July 5. “The funds raised will support U.S. commercialization of Febridx, to build our pipeline and to expand our operations so that we have the facilities and infrastructure in place to do automated assembly and manufacturing,” Lumos Diagnostics CEO Rob Sambursky told BioWorld.
Lumos Diagnostics Holdings Pty. Ltd. scooped up AU$25 million (US$17.9 million) in an oversubscribed pre-IPO ahead of its anticipated 2021 listing on the Australian Securities Exchange (ASX). The funds will be used to expand manufacturing operations in California and Florida and to grow the commercial footprint of Febridx, a rapid point-of-care (POC) test that can determine if a person has a viral or bacterial infection within 10 minutes.
With an eye toward expanding the reach of its Febridx rapid point-of-care (POC) test, Lumos Diagnostics Holdings Pty. Ltd. has seen the closing of a $15 million series A round from Australia’s Planet Innovation. The funds will back a U.S. FDA pivotal clinical trial, as well as additional development and manufacturing resources for the company’s expanding full-service POC business.
