Biodesix has reported that its lung diagnostic test distribution and revenue has increased over 50% compared to this time last year.
For its first-quarter 2024 update (ending March 31), Biodesix reported lung diagnostic revenue of $13.8 million and test volume growth of 60%. The company's blood-based tests target evaluating cancerous lung nodules for management based on the probability that the lung nodule is cancer.
Revenue growth was driven by the protein biomarker test Nodify Lung. One component, Nodify CDT, obtained Medicare coverage in June 2022 and was approved in June 2023 as an advanced diagnostic laboratory test (ADLT) under the Medicare Clinical Laboratory Fee Schedule. The other component, Nodify XL2, made it into private-payer coverage policies in late 2022.
In the past, Biodesix has noted its Oracle observational registry study to demonstrate the clinical utility of the BDX-XL2 test. BDX-XL2 is a proteomic risk predictor that integrates the expression levels of two proteins with five clinical risk factors and issues a benign score. During its initial ADLT payment period, BDX-XL2 was priced at $3,520.
The Oracle study, set for completion this month, will report on the potential of BDX-XL2 to reduce unnecessary invasive procedures, such as biopsies and surgeries, on benign lung nodules, while not significantly increasing the number of malignant lung nodules routed to CT surveillance.
Key points highlighted in Biodesix's first-quarter update include:
- A new master collaborative research agreement with Memorial Sloan Kettering Cancer Center under which the teams will collaborate on the development of diagnostic tests aimed at improving the treatment of cancer.
- Progress on the FLAURA2 study, sponsored by AstraZeneca, to demonstrate the use of the Biodesix blood-based droplet digital (dd) PCR epidermal growth factor (EGFR) test.
- Biopharmaceutical services and other revenue of $1 million.
