LungLife AI (LLAI has enrolled its first patient in a multi-centre clinical study it is conducting to evaluate the company’s LungLB® test in subjects presenting with indeterminate lung nodules.
This first patient enrolment confirms that LungLife AI is on track to enrol patients over the next 14 months, with study completion expected in 1Q23 and in-line with expectations, it stated.
The Company, which develops clinical diagnostic solutions for patients with lung cancer, said the clinical study will be used to validate the company’s LungLB® test performance, looking to repeat the high performance already observed in the pilot study completed earlier in the year.
LungLB® is an AI-enhanced, blood-based test to stratify cancerous and benign lung nodules identified by CT scan, and is designed to support a physician’s decision to biopsy or to monitor non-invasively using additional imaging. The test utilises FISH (Fluorescence in situ hybridization) techniques to identify rare target cells isolated from whole blood, it explained.
The study will enrol 425 participants across multiple US sites, including MD Anderson Cancer Centre and Mount Sinai Hospital in New York in the United States, involving participants who present with indeterminate lung nodules that would otherwise be scheduled for needle biopsy.
LungLife said it is estimated that over 5 million chest CT scans are performed in the US each year with over 1.5 million of them showing indeterminate lung nodules which require further imaging or potentially unnecessary and risky biopsy to determine whether they are cancerous.
LungLife believes study completion is key to offering the test commercially through its CLIA-certified laboratory, in addition to supporting its desire to pursue FDA submission.
Paul Pagano, Chief Executive Officer of LungLife, said: “I am delighted that we remain on track with this key validation study and first patient enrolment. This is an important milestone on our journey towards the successful commercial roll-out of our blood-based diagnostic test, which we believe is set to become a driving force in the early detection of lung cancer.”
Earlier this month, LungLifeAI told investors that it had been granted a CPT® Proprietary Laboratory Analyses (PLA) code for LungLB® by the American Medical Association (AMA).
The new code, which was approved and published by the AMA Editorial Panel, is scheduled to become effective on 1 April 2022, the company told investors. LungLife’s diagnostic solutions are designed to make a significant impact in the early detection of lung cancer.
The CPT® code is expected to mark ‘the first step’ on a path for commercial reimbursement.
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