Biodesix (NASDAQ:BDSX) is focused on developing diagnostic tests intended to improve patient outcomes by answering specific clinical questions, Chief Financial Officer Robin Cowie said at a Barclays event. Commercially, the company’s primary emphasis is lung disease, while its research, development, and biopharma services operations are broader, spanning “pan-cancer and pan-disease,” Cowie said.
Portfolio centered on lung diagnostics
Cowie said Biodesix currently has five lung tests on the market, all with Medicare coverage. Two of those tests are used after a lung nodule is identified to help determine which patients are more likely to have malignancy and should move to biopsy or surgery, and which can safely be monitored with CT surveillance. The company also has three tests aimed at helping guide treatment decisions once lung cancer has been diagnosed.
Where Biodesix fits in the patient workflow
In the U.S., Cowie cited an estimate of roughly 6 million patients annually with a lung nodule. He said most nodules are discovered incidentally—such as during imaging for a shoulder injury or cardiac test—rather than through organized screening. Cowie characterized U.S. lung cancer screening adoption as “very, very poor.”
Biodesix’s nodule-risk tests are typically ordered after a lung nodule is found, Cowie said, to help physicians determine whether a patient should proceed to an intervention or can be safely followed through CT surveillance. He also highlighted care-path inefficiencies the company is targeting, including his comment that:
- About 20% of patients who go on to CT surveillance actually have cancer and should have received an intervention.
- About 65% of patients who get a biopsy did not need it.
- About 35% of patients who undergo surgery and have a portion of their lung removed did not need it.
Cowie said the clinical rationale for more diagnostic information can be straightforward for physicians, but the harder part is logistics—integrating the ordering process and workflow in medical offices.
Multi-omics approach and emphasis on targeted testing
Cowie described Biodesix’s technology stack as incorporating genomics, proteomics, and radiomics/artificial intelligence, with different methods used depending on the clinical question. For the Nodify lung nodule-risk tests, Biodesix uses proteomic methods, including ELISA and LC-MS, to measure proteins and autoantibodies in blood, Cowie said.
On the treatment guidance side, Cowie said Biodesix uses ddPCR for a targeted gene mutation panel and a Thermo Fisher NGS platform for next-generation sequencing. He also discussed VeriStrat, a proteomic test measured via MALDI-TOF mass spectrometry that, he said, assesses aspects of the patient’s immune system—specifically whether an acute chronic inflammatory response has been triggered.
When asked about the industry shift toward broader sequencing such as whole exome or whole genome approaches, Cowie said Biodesix believes a more targeted strategy can be more practical for “general population and general use,” particularly for community clinics that may not have the same capabilities as large academic centers.
Reimbursement, margins, and commercial momentum
Cowie said reimbursement remains a “long and hard” process that requires publishing clinical utility data to demonstrate impact on care. In lung, he noted that about 60% of patients are Medicare beneficiaries, and Biodesix has Medicare coverage across its on-market lung tests. He added that the company is seeing “good momentum” with commercial payers for Nodify, citing strong increases in average selling price over the last four quarters and saying non-reimbursed volume is a “relatively small and shrinking percentage.”
On profitability, Cowie said Biodesix reported 81% gross margins for the prior year and credited operational optimization in clinical proteomics. He also noted the company achieved adjusted EBITDA profitability in the fourth quarter of last year and said the near-term priority is growing the commercial organization and top-line revenue to reach sustainable adjusted EBITDA and cash flow positivity.
Services business, partnerships, and pipeline priorities
Cowie said the company’s biopharma services activity is primarily tied to IQLung testing, but also includes test discovery, development, and support for regulatory and reimbursement efforts up through commercialization. He pointed to a partnership announced last fall with Bio-Rad, in which Biodesix developed an ESR1 test for breast cancer on the ddPCR platform, moving “from contract to LDT in about four months,” which he described as rapid and scalable.
Demand for the services business is increasing, Cowie said, adding that backlog is higher than the company has seen before. He emphasized that services work leverages the same equipment and personnel used for commercial testing, which he said creates operating leverage.
Looking ahead, Cowie outlined several development areas, including a combined MRD and proteomic test being developed with Memorial Sloan Kettering Cancer Center, efforts to expand VeriStrat into other tumor types (with studies conducted across nine tumor types and new data presented last year in prostate cancer and others), and “digital diagnostics” that use imaging as an input—particularly relevant in lung care where CT imaging is routinely available.
On commercialization infrastructure, Cowie highlighted the importance of EMR integrations to streamline ordering, reduce reliance on paper and fax, and help identify appropriate patients. He also described ongoing sales force expansion: Biodesix added about 35 sales reps last year, growing from roughly 65 to nearly 100, and plans to add another 25 this year. Cowie said fourth-quarter average revenue per rep was about $1 million, which he framed as a baseline, noting that many reps were newly hired in the second half of the year.
In terms of channel mix, Cowie said Biodesix is in the “mid-single digits” of pulmonologist penetration and has only recently begun calling on primary care. He said primary care volumes in the fourth quarter were about 12%, with nearly 70% year-over-year growth from that group, while pulmonology grew about 28% on a larger base.
About Biodesix (NASDAQ:BDSX)
Biodesix, Inc is a commercial-stage molecular diagnostics company headquartered in Boulder, Colorado, that develops and delivers blood-based tests to improve the diagnosis and management of lung diseases, including lung cancer. The company integrates advanced proteomic and, more recently, genomic technologies to offer noninvasive testing solutions designed to guide clinical decision-making. Biodesix operates a CLIA-certified and CAP-accredited laboratory, allowing it to process patient samples at scale and maintain rigorous quality standards.
The company’s flagship product, VeriStrat®, is a proteomic test that stratifies patients with non-small cell lung cancer into groups more likely to benefit from specific therapies.
