LungLife AI Inc on Friday said it has won a Clinical Laboratory Evaluation Program permit from the New York State Department of Health.

LungLife is a developer of diagnostic solutions for lung cancer, based in Thousand Oaks, California.

The CLEP permit allows LungLife to perform clinical utility studies and offer the LungLB test commercially in New York. The company is also permitted to carry out these studies in 46 other states, under its existing Clinical Laboratory Improvement Amendments certification.

The permit was awarded following an on-site audit by the NYSDOH. This ensures that the premises, laboratory practice, equipment, personnel, and record-keeping methods meet state requirements.

LungLife said that this is an ‘important step’ in its commercialisation plan. It is currently undergoing a validation trial at the Icahn School of Medicine at Mount Sinai in New York, and the company is now able to accept study participants in future utility studies.

It added that CLAP is a requirement to consider participants from New York state in its utility studies planned for 2023, from which the company expects first nominal revenues.

Lara Baden, vice president of Clinical Operations for LungLife, said: ‘We are pleased to have received a CLEP permit from the NYSDOH. Not only does this provide further validation of our best-in-class quality system, but also approval of the LungLB test means that LungLife can offer this service to physicians in New York state who evaluate indeterminate lung nodules for early cancer detection.’

LungLife shares were untraded at 112.50 pence each in London on Friday morning.

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