LungLife test secures Medicare coverage determination

Lung cancer diagnostic technology developer LungLife AI announced the finalisation of Medicare coverage for its molecular risk-stratification test, LungLB, aimed at evaluating indeterminate pulmonary nodules, on Friday.

The AIM-traded firm said the local coverage determination (LCD), titled ‘Molecular Biomarkers for Risk Stratification of Indeterminate Pulmonary Nodules Following Bronchoscopy’, was issued by Noridian Healthcare Solutions, the Medicare administrative contractor overseeing LungLife's California laboratory.

Effective for services rendered on or after 22 September, the Medicare coverage would allow LungLife to apply for reimbursement for LungLB tests, marking a crucial step toward the commercialisation of the test.

LungLB is priced at $2,030 per test, and the assignment of a billing code in January 2022 had already set the groundwork for this reimbursement process.

The board said the finalised Medicare policy outlined the criteria under which molecular tests like LungLB could be used to aid in the diagnosis of lung cancer in patients who had undergone non-diagnostic bronchoscopies, addressing a significant clinical need.

Nearly half of all bronchoscopy biopsies failed to provide a definitive diagnosis, underscoring the importance of risk stratification tests in guiding follow-up care.

LungLife said it was now eligible to submit a technical assessment for LungLB under this LCD for post-bronchoscopy indications, with potential for future expansion into pre-bronchoscopy coverage.

MolDX, which oversees the evaluation of molecular diagnostics for Medicare, was considering additional evidence that could broaden the scope of coverage, presenting further opportunities for LungLife.

With the LCD in place, LungLife said it had successfully secured the three key components necessary for the commercial launch of LungLB - a billing code, a set price, and now Medicare coverage.

That, it said, paved the way for wider adoption of the test by healthcare providers, facilitating earlier and more accurate lung cancer diagnoses for patients with indeterminate lung nodules.

“Having a local coverage determination (LCD) for risk stratification testing of indeterminate lung nodules represents a key opportunity for our company,” said chief executive officer Paul Pagano.

“It enables us to progress to the next stage of commercialisation by providing a clear pathway to make our innovative LungLB test more accessible and reimbursable under Medicare.

“This supports our commitment to enabling 80% of lung cancer to be detected early.”

At 0910 BST, shares in LungLife AI were up 12.65% at 13.8p.

Reporting by Josh White for Sharecast.com.