IONIQ Sciences’ ProLung Test Accepted for Submission to China’s National Medical Products Administration
September 25, 2020
IONIQ Sciences, based in Salt Lake City, and a BioUtah member, announced September 20 that its IONIQ ProLung Test™ for lung cancer has been formally accepted for submission to China’s National Medical Products Administration (NMPA), formerly known as the Chinese Food and Drug Administration (CFDA).
Mr. Jared Bauer, IONIQ Sciences CEO, stated, “We are excited about the continued progress with our long-time partner in China. It is a tremendous accomplishment for us to be in the regulatory process to market the IONIQ ProLung Test in both China and the USA.”
“This news will expand IONIQ’s reach,” said Kelvyn Cullimore, president and CEO of BioUtah. “It means that the company’s IONQI ProLung Test™ is now in the regulatory process in both the U.S. and China. Earlier this year, the FDA designated the ProLung Test a “Breakthrough Device,” recognizing its innovation in lung cancer screening.”
The regulatory submission to the NMPA by IONIQ’s Chinese partner, ProLung Biotech Wuxi Co, is based on exceptional clinical trial results of 84% sensitivity and 73% specificity that are superior to the clinical status quo of low-dose computed tomography.
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