Home PRESS RELEASE Imagene Advances LungOI Commercialization With New Payment Code and Pricing, Complementing Its Prior CLIA Certified US Lab

Imagene Advances LungOI Commercialization With New Payment Code and Pricing, Complementing Its Prior CLIA Certified US Lab

by Ohio Digital News

LungOI Is Among The First AI-based Tests To Receive a Medicare Payment Rate.

Imagene, a pioneer in AI-based precision oncology, is pleased to announce the culmination of key milestones in the commercialization of its AI-based NSCLC Biomarker Profiling Test, LungOITM. Earlier this year, Imagene secured a novel payment code and payment rate from the Centers for Medicare and Medicaid Services (CMS).

This follows the release of the LDT product to the market in Q1 2024, after receiving CLIA certification in Q1 2023. Together with the test-specific code and Medicare payment rate, LungOI is well-positioned as a leading AI-based LDT product for detecting lung genomic alterations.

Through its CLIA lab, Imagene enables wide access to the LungOI test, delivering predictive analysis of NSCLC genomic alterations from H&E slides within minutes. LungOI provides same-day results to physicians and is expected to enhance patient care through the rapid and cost-effective triaging of patient samples to a primary diagnostic assay.

“This is a major milestone in our efforts to commercialize our flagship product, paving the way to integrate validated cutting-edge technology into clinical pipelines and advance cancer care,” said Dean Bitan, Co-founder and CEO of Imagene. “It also showcases the strength of our core technology, a state-of-the-art Oncology Intelligence Foundation Model specifically designed to address oncology diagnostic and research challenges.”

Dr. Ross Camidge, Professor of Medicine, Joyce Zeff Chair in Lung Cancer Research, Director of Thoracic Oncology at the University of Colorado, elaborated “Oncologists already use clinical features like race and smoking status to manage decision-making in terms of when treatment delays pending molecular results are likely to be appropriate. They also use them to influence when additional narrow but rapid tests might be helpful for optimizing time or tissue utilization. I would definitely use a science-forward, reliable, and ultra-rapid AI test to enhance this process in supporting an informed clinical decision.”

Imagene is now driving the expansion of payer coverage for LungOI through early access programs to ensure evidence generation and demonstration of the benefits of Immediate Oncology Intelligence for both physicians and their patients. 

Imagene’s executive team will be showcasing its full product line at the upcoming American Society of Clinical Oncology (ASCO) conference, May 31 – June 4, Booth #10064.

LungOI is clinically available through Imagen’s CLIA-certified laboratory in Arizona and can be ordered online by a physician at Imagene-ai.com.

About Imagene
Imagene is an emerging leader in AI-based precision oncology, leveraging AI to profile a broad range of cancer biomarkers from digitized biopsy images within minutes. The company empowers physicians with immediate oncology intelligence to facilitate optimal treatment for more cancer patients. Imagene is the developer of LungOITM, the first AI-based NSCLC Biomarker Profiling Assay. Awarded the 2023 Digital Health Award for “Best Use of AI in HealthTech” and the Technology Leadership Best Practices Award by Frost & Sullivan, Imagene’s success derives from its cutting-edge Oncology Intelligence (OI) technology and a multidisciplinary team of experts dedicated to advancing precision oncology and improving patient care. 

For more information, please visit imagene-ai.com.

Source: Imagene

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