TEST:

Nodify XL2™

P=N/A, N=2000, Active, not recruiting, Biodesix, Inc. | Recruiting --> Active, not recruiting

While advanced NSCLC patients benefit from targeted therapy, early-stage patients may undergo surgery followed by adjuvant cisplatin-based chemotherapy or stereotactic body radiotherapy (SBRT)...In conclusion, the review underscores the multidisciplinary approach required for effective lung cancer management. Advances in early detection, personalized treatment, and the integration of technology and biomarkers offer hope for improving outcomes and reducing the global burden of lung cancer.

P=N/A, N=2000, Recruiting, Biodesix, Inc. | Trial primary completion date: Dec 2024 --> Dec 2025

"Biodesix, Inc...announced that new data will be presented at the CHEST Annual Meeting 2024 in Boston, Massachusetts on Tuesday, October 8 at 10:20 am ET. The presentation will detail the experience of healthcare providers using the Nodify Lung Nodule Risk Assessment in over 35,000 patients consecutively tested in a real-world clinical setting....At the CHEST conference, 'Use of a blood-based biomarker for indeterminate nodules in community settings,' will be presented by Kathryn Long, MD of the Medical University of South Carolina. It will describe clinical use patterns and national reclassification rates consistent with prior studies, highlighting the high proportion of results that up- or down-classify patients into actionable risk categories with clear, guideline-recommended, diagnostic plans."

He was started on a course of levofloxacin with no improvement...He was prescribed amoxicillin-clavulanic acid...Once diagnosed, treatment of Mycoplasma pneumoniae includes azithromycin, macrolides, doxycycline, or fluoroquinolones. We are reporting a novel case of Mycoplasma pneumoniae mimicking as a bronchogenic carcinoma exhibiting discordant radiographic images and the rare symptom of pleurisy. The new Nodify® proteomic biomarker blood test contributed to the workup and averted the need for unnecessary invasive procedures.

"Biodesix, Inc...announced that new data will be presented today at the 2024 American Thoracic Society (ATS) International Conference in San Diego, California. The presentation, titled 'Performance comparison of a blood-based integrated classifier for lung nodule risk stratification in patients with versus without emphysema,' will be presented by Arthur Romero MD, MSC, FCCP, Associate Professor of Pulmonary and Critical Care Medicine at the University of Nevada Las Vegas."

"Biodesix, Inc...announced...the validation and launch of a new method of collecting blood specimens for Nodify Lung Nodule Risk Assessment testing. The method uses the FDA-cleared Tasso+™ device, a single-use blood lancing device intended for obtaining capillary whole blood samples from a patient’s upper arm."

"Biodesix, Inc...announced that new data will be presented at the CHEST Annual Meeting 2023 in Honolulu, Hawaiʻi. These presentations will provide new insight on the clinical utility and real-world impact of the Nodify CDT and Nodify XL2 tests in the comprehensive management of lung nodules....The presentation will delve into subgroup analyses from the prospective, real-world ORACLE study (NCT03766958), evaluating the clinical utility of the Nodify XL2 test across the spectrum of nodule types.... The presentation will demonstrate the complementary nature of the Nodify CDT test and PET/CT imaging results."

Dr. Jonathan Kurman is the Director of Interventional Pulmonology and Assistant Professor of Medicine at the Medical College of Wisconsin.

P=Obs | N=842 | NCT03766958 | Sponsor: Biodesix, Inc. | "Biodesix, Inc...announced today that a new analysis from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2 Test NCT03766958) will be presented at the 6th Annual Conference of the American Association for Bronchology and Interventional Pulmonology (AABIP)....The primary endpoint of the ORACLE study demonstrated that patients with benign lung nodules managed with the test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group."

P=Obs | N=842 | ORACLE (NCT03766958) | Sponsor: Biodesix, Inc. | "Biodesix, Inc...announced today that the prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2^® Test [NCT03766958]) achieved the primary endpoint of a statistically significant change in the proportion of benign lung nodules managed by Nodify XL2^® experiencing invasive procedures....In ORACLE, the prospective, real-world clinical utility study, patients with benign nodules managed with the Nodify XL2 test were 74% less likely to undergo an unnecessary invasive procedure compared to the control group. Additionally, the proportion of patients sent to CT surveillance with malignant nodules did not differ between the Nodify XL2 group and the control group."

"Biodesix, Inc...presented original data in four separate poster presentations at the ISPOR (International Society for Pharmaceutical and Outcomes Research) conference, providing evidence of the health economic benefits of the Nodify CDT® and Nodify XL2® tests in the management of pulmonary nodules. The posters, presented May 8-9, 2023, highlighted potential cost savings in both Medicare and commercially insured patient populations with use of the tests."