Biodesix, Inc. reports developments as a diagnostics solutions company focused on lung disease testing and biopharma development services. Its updates center on Diagnostic Tests such as Nodify Lung® Nodule Risk Assessment, Nodify CDT® and IQLung® Cancer Treatment Guidance, along with blood- and tissue-based testing, proteomic and genomic approaches, and development work for life sciences partners.
Recurring news also covers quarterly results, revenue guidance, test-volume trends, clinical validation studies, real-world evidence presentations at medical meetings, and the company’s efforts to expand evidence for lung nodule management and oncology testing applications.
Biodesix (BDSX) reported third-quarter 2026 revenue of $24.0 million, up 10% year over year, alongside narrower losses.
Diagnostic Testing revenue rose 16%, with test volumes up 24% to 19,400, partly offset by lower average revenue per test. Development Services revenue fell to $986,000 from $1.933 million. Gross margin remained 81%. Net loss narrowed 8% to $8.0 million; adjusted EBITDA, a non-GAAP earnings measure, was a $3.9 million loss, improving 16%.
Cash ended September at $28.4 million, down $1.6 million from June despite $6.3 million in net proceeds from share sales. Biodesix now expects 2026 revenue of $101 million to $103 million and gross margins of approximately 80%. Growth fell below company expectations amid sales staffing shortfalls, seasonality and customer-related project delays. The company anticipates commercial availability of its first Digital Diagnostics test in 2028.
Biodesix (Nasdaq: BDSX) announced that members of its leadership team will participate in two upcoming investor conferences in November.
The UBS Global Healthcare Conference includes a fireside chat on November 10 at 2:45 PM ET and one-on-one meetings in Palm Beach Gardens, Florida. The Craig-Hallum Alpha Select Conference consists of one-on-one meetings only on November 17 in New York. The presentation will be webcast live, with a replay available under News & Events in the Investors section at Biodesix.com.
Biodesix (BDSX) will release its third-quarter 2026 financial results after the close of trading on November 5, 2026. The results cover the quarter ended September 30, 2026. Management will host a conference call and webcast at 4:30 p.m. Eastern Time that day to discuss the results and provide a general business update.
Biodesix (NASDAQ: BDSX) announced that the American College of Chest Physicians published a lung nodule program framework incorporating validated biomarker testing.
The framework, “Building a Lung Nodule Program: From Detection to Diagnosis,” describes six steps for establishing programs. It positions validated biomarker testing, such as Biodesix’s Nodify Lung tests, as a core component of standardized risk assessment to guide clinical decisions. A multidisciplinary panel of interventional pulmonologists, thoracic surgeons and diagnostic radiologists developed the framework using published clinical evidence and experience from established programs.
Biodesix (BDSX) added Digital Diagnostics to its lung diagnostics strategy, developing a lung nodule risk test with Vanderbilt University and Vanderbilt Health. The platform combines blood biomarkers, imaging biomarkers and artificial intelligence. Its first test uses radiomics—quantitative information extracted from medical images—to complement the Nodify Lung blood-test portfolio. Biodesix anticipates commercial availability in 2028 through its established commercial channels.
Initial performance data will be presented at RSNA on December 3, 2026. Biodesix received institutional review board approval for STRATIFY, a prospective study expected to begin in the fourth quarter of 2026. It has also engaged with the FDA on a regulatory pathway and Medicare on future commercialization, and established an Independent Diagnostic Testing Facility to support clinical testing and future scale.
Biodesix (BDSX) announced presentations on Nodify Lung testing in routine lung nodule care at CHEST 2026 on October 19–20.
Sponsored research will examine blood-based biomarkers alongside PET imaging, diagnostic test sequencing, and performance in patients with ground glass opacity lung nodules. The CLARIFY study has enrolled more than 2,000 patients who received Nodify Lung testing in routine clinical practice. Independent presentations address patient follow-up and changes in risk assessment. A separate case report compares IQ Lung liquid biopsy with tissue testing for EGFR detection.
Biodesix (BDSX) announced progress on two blood-based molecular residual disease programs with Bio-Rad Laboratories and Thermo Fisher Scientific on September 24, 2026.
The tests aim to detect circulating tumor DNA, or ctDNA, to check whether cancer remains or returns after treatment. The tumor-informed approach uses Biodesix's Diagnostic Cortex to identify changes in a patient's tumor, then Bio-Rad's Droplet Digital PCR to track them in blood. Its analysis workflows detect ctDNA below 1 part per million of total DNA in a blood sample. The newly launched tumor-naïve program with Thermo Fisher uses methylation patterns and sequencing on the Genexus platform without requiring tumor tissue.
Biodesix has begun developing and validating the tumor-naïve assay. Both approaches are to be validated with investigators at Memorial Sloan Kettering Cancer Center and are designed to run on partner platforms already installed in laboratories worldwide.
Biodesix (BDSX)/b) announced that Vice President of Quality and Regulatory Affairs, Brianna Phillips, will speak at the upcoming 2026 Regulatory Affairs Professionals Society (RAPS) and Society of Clinical Research Associates (SOCRA) annual meetings.Phillips leads Biodesix’s QA/RA program supporting five on‑market diagnostic blood tests and has built a full portfolio of lab accreditations over 12 years, including CLIA, CAP, NYS CLEP, ISO 13485, and FDA registrations, as well as a GMP FDA‑registered facility. Biodesix notes that its labs are among about 1,135 NYS CLEP and 7,000 CAP‑accredited labs nationwide. The company states its quality and regulatory systems help accelerate patient access to Nodify Lung and IQLung test portfolios, which have been used in the care of more than 100,000 patients.
Biodesix (BDSX) will participate in three investor conferences in September 2026, focusing on meetings with investors and a scientific panel appearance in New York.
The company will attend Lake Street Capital Markets’ 10th Annual Best Ideas Growth (BIG10) Conference for 1x1 meetings on Thursday, September 10, and the H.C. Wainwright 28th Annual Global Investment Conference for 1x1 meetings on Tuesday, September 15, both in New York. Biodesix will also join the 5th Annual Roth Healthcare Opportunities Conference in New York, where Chief Scientific Officer Gary Pestano, Ph.D., will speak on a panel titled “The Rise of MRD Monitoring in Solid Tumors, and Where it Goes Next” on Tuesday, September 29 at 2:00 PM ET.
Biodesix (Nasdaq:BDSX) reported second quarter 2026 revenue of $26.9 million, up 34% year-over-year, with Diagnostic Testing revenue of $25.3 million, up 42% on a 38% increase in test volumes to 20,900 and higher average revenue per test.
Gross margin reached 82%, a 200-basis point improvement, while operating expenses excluding direct costs rose 7% to $27.4 million. Net loss narrowed to $7.3 million, a 37% improvement, and Adjusted EBITDA loss improved 56% to $3.2 million. Cash and cash equivalents were $30.0 million, up 17% from March 31, 2026, including $6.5 million of net proceeds from an at-the-market program. For full year 2026, Biodesix maintained total revenue guidance of $108–114 million, targeting approximately 25% growth at the midpoint and gross margin of about 80%, with continued Adjusted EBITDA improvement toward profitability.