The FDA has given its nod of approval to an artificial intelligence-powered lung cancer assessment tool developed by Onc.AI. It examines CT scans from patients to determine their likelihood of survival and subsequent treatment measures.
On Thursday, the privately held company announced that its Serial CT Response Score AI model had received Breakthrough Device Designation from the American government agency. This is particularly beneficial for Onc.AI because it can accelerate the review process for its technology and get it to market faster.
“Onc.AI aims to equip oncologists with vital, automated prognostic insights using routinely collected diagnostic imaging scans,” founder and CEO, Akshay Nanduri, said, “and ultimately improve treatment strategy while providing risk stratification throughout a cancer patient’s journey.”
Onc.AI highlighted that its deep learning AI model has demonstrated the ability to predict overall survival with significantly superior efficiency than imaging assessment tools used in the past. The company says it recently presented results from an extensive study demonstrating this finding to the Society for Immunotherapy of Cancer.
Onc.AI was founded in 2020 and is based out of California. The company also has a Canadian office in Waterloo, Ontario.
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Designation offers other benefits
In addition to providing a streamlined path to market, the Breakthrough Device Designation offers opportunities for flexible study designs that other companies wouldn’t be eligible for.
It will also foster an increased rate of dialogue between the FDA and Onc.AI, which can be highly beneficial as the company continues developing its non-small cell lung cancer scan analysis tool.
Additionally, the designation serves as a signal to investors that the technology is worthwhile, likely leading to increased funding opportunities that companies without it wouldn’t be qualified for.
Onc.AI has raised a total of US$33 million to date.
The National Cancer Institute provided the company with a US$2-million-dollar grant for its research in October.
rowan@mugglehead.com
