BIODESIX INC. DL -,001

Biodesix announced the publication of a clinical validation study for the Nodify CDT blood test; a retrospective analysis of 1,100 patients showed a specificity of 91–97% for lung nodules measuring 4–30 mm. The test is clinically available and is intended to support the decision between surveillance and early intervention. Financial data: market capitalization of $160.69 million, revenue of $88.5 million over 12 months with a gross margin of 81%, but the company remains unprofitable; analysts currently view the stock as overvalued. » More on de.investing.com

Biodesix announced an expanded agreement with Bio‑Rad to develop, clinically validate and seek regulatory approval for in vitro diagnostic tests on the QX600 droplet digital PCR platform. The initial focus is the ddPLEX ESR1 Mutation Detection Assay to detect multiple ESR1 mutations in ctDNA; after approval Biodesix plans to offer the test as a service from its CLIA‑ and CAP‑accredited lab and to sell sample collection kits. Target markets are biopharma customers and clinical monitoring; the company also intends to pursue reimbursement from the Centers for Medicare & Medicaid Services. The company recently completed a 20:1 reverse stock split, after which Canaccord Genuity lowered its price target but maintained a buy rating. » More on de.investing.com

Biodesix presented its strategic realignment at the Canaccord Growth Conference, emphasizing expansion of primary care services, partnerships in the biopharma sector and digitalization of ordering processes. The company beat expectations for Q2, reported a high gross margin of 80%, plans to hire sales staff and is targeting adjusted EBITDA break-even and positive cash flow, while research projects such as an MRD test in cooperation with Memorial Sloan Kettering are progressing. Financial measures to manage cash burn and a review of financing options were also announced. » More on de.investing.com