- LungLife AI, Inc (DI)
- 02 October 2024 14:03:12
Source: Sharecast
The AIM-traded firm said the publication, titled Analytical Validation of the LungLB test: a 4-colour fluorescence in-situ hybridization assay for the evaluation of indeterminate pulmonary nodules, confirmed the analytical performance of LungLife's diagnostic solution for lung cancer and adds to the body of evidence supporting its use.
It described publication in a journal such as BMC Pulmonary Medicine as a critical step in the commercialisation process for LungLB, as it enhanced the credibility and reliability of the test within the scientific and medical communities.
The peer-reviewed validation, alongside previous data published in 2023 on clinical validity and health economics, strengthened the case for Medicare reimbursement, which would make LungLB available to a broader range of patients.
LungLife AI said the validation was conducted according to Clinical and Laboratory Standards Institute (CLSI) guidelines, recognized by the US FDA.
The results demonstrated that the LungLB test performed consistently and reliably, regardless of lab technician, timing, or batch of materials, further supporting its robust design and reproducibility under various clinical and laboratory conditions.
“Having the results of our study peer-reviewed and published is a significant milestone, validating the scientific rigour of our research,” said chief executive officer Paul Pagano.
“This achievement is a key part of our commercialisation strategy to build a bank of evidence of the efficacy and utility of our testing.
“It underscores both the credibility of our LungLB test and provides greater confidence in its use, and importantly, by raising awareness about the test it supports our commitment to expanding access for those who need it most.”
At 0957 BST, shares in LungLife AI were down 1.09% at 11,38p.
Reporting by Josh White for Sharecast.com.