TEST:

Nodify CDT™

"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...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."

In conclusion, Nodify CDT demonstrated improved specificity compared with PET/CT. Risk stratification with CDT compared with PET/CT resulted in fewer patients with benign disease being reclassified as high risk. CLINICAL IMPLICATIONS: A positive Nodify CDT test can be used to identify likely malignant lung nodules with a significantly lower rate of false positives compared with PET/CT alone.

"Biodesix, Inc...announced that the Centers for Medicare & Medicaid Services (CMS) has designated the Nodify CDT® Test as an Advanced Diagnostic Laboratory Test (ADLT) effective June 30, 2023...The payment amount for the Nodify CDT test as established by the Medicare Administrative Contractor is $649."

"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...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."

Elevated AAbs identified early-stage NSCLC and SCLC, indicating the potential to accelerate time to diagnosis. Further clinical trials are ongoing to understand the clinical utility of incorporating blood biomarkers to expedite early-stage lung cancer diagnosis.

30% of patients at our institution were reclassified from intermediate pCA (5-65%) to low risk (65%) using Nodify CDT and XL2 testing. Reclassification informed further management and was routinely incorporated into the shared decision-making discussion with patients. CLINICAL IMPLICATIONS: Management of lung nodules with an intermediate risk of malignancy remains an area of significant ambiguity.

"Biodesix, Inc...announced that WPS Government Health Administrators, the Medicare Administrative Contractor with jurisdiction for Biodesix’s De Soto, Kansas laboratory, has provided coverage for the Nodify CDT® lung nodule test...The Nodify CDT test is a part of the Biodesix’s blood-based Nodify Lung® Nodule Risk Assessment testing strategy consisting of two tests to aid physicians in stratifying patients into distinct nodule management treatment pathways: diagnostic procedure or imaging surveillance."

"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."

The AAbs detected by the CDT test are able to identify likely malignant nodules regardless of lung cancer type, histology, or stage indicating that the test is an independent risk factor the physician may use to help with the identification of lung cancer. Furthermore, the majority of CDT+ IPNS were diagnosed with Stage I NSCLC or Limited Stage SCLC. CLINICAL IMPLICATIONS: Elevated AAbs can be detected in patients with early-stage NSCLC and SCLC, suggesting that implementing blood-based testing in nodule patient management may improve early diagnosis of lung cancer.

The results of this retrospective analysis confirm the previously reported (Healey et al 2017) performance of the Nodify CDT test including high specificity and PPV necessary for accurately identifying patients with likely malignant lung nodules that will benefit from a more rapid evaluation and extended follow up if initially benign. CLINICAL IMPLICATIONS: The Nodify CDT blood test can identify likely malignant lung nodules that may benefit from a more rapid evaluation.

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.