Indica Labs receives FDA clearance for digital pathology platform
May 20—Albuquerque's Indica Labs announced last week a milestone for the company that provides pathologists and researchers with a modern platform and digital suite for evaluating and diagnosing diseases and conditions using advanced imaging techniques.
The milestone for Indica is Food and Drug Administration clearance for its HALO AP Dx digital pathology platform for primary diagnosis.
HALO AP Dx is a software platform for viewing and sharing digital images. It works with the Hamamatsu NanoZoomer Slide scanner, which produces images that are analyzed with the help of the HALO AP Dx software. HALO AP is deployed worldwide and has transformed the way pathologists and researcher analyze, manage and utilize digital pathology images, according to a news release from Indica.
Company founder and CEO Steven Hashagen explained the state of the science and why the FDA clearance is an important development.
"Pathology is basically the practice of studying disease and the disease process," Hashagen said, "and pathology has gone digital in recent years. Basically, instead of looking at tissue through a microscope and studying the tissue through a microscope, you actually can now do it through a computer screen and look at a digitized image of the tissue. Open pathology is the practice of doing that with tools and software that really interoperate nicely with one another."
The company serves more than 800 customers globally.
"It's really, really big news," said Hashagen in a phone call. "This FDA clearance unlocks a large clinical customer base and creates a range of new business opportunities. It is a transformative moment for Indica Labs.
"It's important because it allows us to market this product," Hashagen said. "Without that clearance, it cannot be used for diagnostic use in the U.S. without the customer doing their own validation. Now it allows us to market it as a medical device."
That means hospitals, academic medical centers, laboratories, and pharmaceutical and biotech companies can use the platform for primary pathology diagnosis, collaboration, and second opinions. Because slides are available for review from any location the moment they are scanned, researchers can work remotely and have remote consultations, which is particularly crucial as case numbers increase amid a pathologist shortage.
HALO AP Dx can be deployed in either a cloud-based or on-premises environment, company officials said, granting users freedom of choice as to how their data is stored.
India Labs is headquartered in Albuquerque, with offices in Europe, China and Japan. It's located in a 14,000-square-foot facility in northwest Albuquerque and employs over 60 people, the majority of them computer scientists in New Mexico.
