TEST:

Nodify XL2™

"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."

"Biodesix, Inc...announces new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2023 International Conference. The meeting will take place May 19-24, 2023, in Washington, DC."

P=N/A; N=250; Recruiting; Sponsor:H. Lee Moffitt Cancer Center and Research Institute

"Biodesix, Inc...announced positive coverage decisions from four private payers including Blue Cross Blue Shield of North Carolina, Blue Cross Blue Shield of South Carolina, Blue Cross Blue Shield of Kansas City, and Capital District Physician’s Health Plan (CDPHP) of New York, all effective fourth quarter 2022. Biodesix’s Nodify XL2® test will now be covered for more than 2.3 million enrollees of Blue Cross of North Carolina, 1.2 million enrollees of Blue Cross Blue Shield of South Carolina, 0.5 million enrollees from Blue Cross Blue Shield of Kansas City, and 0.4 million enrollees of CDPHP across New York State."

P=N/A; Trial completion date: Dec 2024 --> Dec 2026 | Trial primary completion date: Dec 2022 --> Dec 2024

"Biodesix, Inc...announced the award of a U.S. Federal Supply Schedule contract which includes the Veterans Health Administration providing care for U.S. Veterans and Military Health System providing care for active-duty service members and their families. The contract covers the company’s entire lung diagnostic portfolio: Nodify XL2®, Nodify CDT®, VeriStrat®, GeneStrat® ddPCR, and GeneStrat NGS™ testing."

P=Obs | N=1,250 | ORACLE (NCT03766958) | Sponsor: Biodesix, Inc. | "Biodesix, Inc...announced today that three data presentations will occur at the CHEST 2022 Annual Meeting which will be held live and in-person for the first time since 2019. Presentations will include a sub-group analysis of data from the post-market, prospective, real-world ORACLE study (An Observational Registry Study to Evaluate the Performance of the Nodify XL2^® Test - ORACLE [NCT03766958]) demonstrating that the Nodify XL2 test has equivalent performance in identifying patients with benign nodules discovered through lung cancer screening programs, compared to those discovered incidentally through medical imaging for unrelated diagnostic purposes. This prospectively collected data reinforces the potential of the Nodify XL2 test to identify high-risk individuals participating in lung cancer screening who have a likely-benign lung nodule and can avoid an unnecessary invasive biopsy."

"Biodesix, Inc...announces new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference. The meeting will take place May 13-18, 2022, in San Francisco, California."

"Spesana...and Biodesix Inc...announced today that they have partnered to further streamline and automate the use of molecular diagnostics in clinical workflows across the United States utilizing Spesana’s digital platform solutions for comprehensive lung cancer management...Spesana’s partnership with Biodesix includes a healthcare platform for clinicians that is beyond the various electronic medical records or lab portals. The platform will incorporate electronic ordering of molecular testing including Biodesix’s blood-based Nodify Lung® Nodule Risk Assessment Testing (Nodify XL2® & Nodify CDT ® tests) and IQlung™ Testing (GeneStrat ® ddPCR, GeneStrat NGS™, & VeriStrat ® tests), all part of a Biodesix’s blood-based treatment guidance portfolio with industry-leading turnaround times."

These data suggest that supplementing physician judgment and standard of care risk assessment with a blood-based IC may reduce the number of invasive procedures performed on benign nodules compared to current real world practices. Further analyses in this patient population to evaluate the overall test performance are ongoing. CLINICAL IMPLICATIONS: The IC test impacts physician decisions and is associated with reduced unnecessary invasive procedure use in a real-world clinical population.

She was treated with itraconazole with decreased size of her nodule... The case is an example of post-operative morbidity after surgical biopsy of a lung nodule that may have been mitigated by a standardized incorporation of proteomic biomarkers into lung nodule decision-making. More detailed direct comparisons of the performance of these biomarkers to more commonly used diagnostic testing may be helpful.

P=N/A; Not yet recruiting --> Recruiting | Trial completion date: Oct 2023 --> Dec 2024 | Trial primary completion date: Oct 2021 --> Dec 2022

Three biomarker tests (Early CDT-Lung, Nodify XL2, Percepta) have undergone extensive validation and are available to the clinician. The authors discuss these tests, with their clinical applicability and limitations, current ongoing evaluation, and future directions for biomarkers in lugn cancer screening and detection.

Performing CDT first identifies patients with a high risk of malignancy that should be evaluated quickly and reduces the prevalence of cancer in the subsequent population analyzed by XL2. Performing XL2 on these remaining patients identifies those who can be more confidently monitored with surveillance with a high level of accuracy. CLINICAL IMPLICATIONS: This combined testing strategy shifts 32% of patients into risk groups with different, guideline recommended diagnostic plans.

These incidental findings are often associated with increased patient anxiety and can delay TAVR procedure. The results of the blood-based lung nodule test do not obviate the need for ongoing radiographic follow-up; however, due to a reported 13% malignancy risk, the patient, his family, and physicians felt more comfortable and recommended moving forward with his TAVR.