COMPANY:

Biodesix

"Biodesix, Inc...today announced that new data was presented at the American Association for Cancer Research (AACR) Annual Meeting 2024 in San Diego, California. These presentations highlight advancements in liquid biopsy technologies that detect cell free DNA (cfDNA) and the clinical value of rapid turnaround time to detect actionable tumor mutations in a real-world clinical setting....An independent presentation of an exploratory analysis from the FLAURA2 clinical study, sponsored by AstraZeneca, was also presented as a plenary session....Results suggest that baseline detection of plasma EGFRm may identify a subgroup of patients who would derive most benefit from the addition of platinum-pemetrexed chemotherapy to osimertinib as first-line treatment for EGFR-mutated advanced NSCLC."

"Biodesix, Inc...announced that it has entered into a new master collaborative research agreement (MCRA) with Memorial Sloan Kettering Cancer Center (MSK) under which the teams will collaborate on a development plan for diagnostic tests aimed at improving the treatment of cancer. Biodesix will utilize its array of genomics, proteomics, and data mining capabilities with the aim of developing and commercializing oncology biomarker assays in collaboration with MSK."

"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."

"Biodesix, Inc...announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC)....'It is crucial to be able to determine which 10-15% of early stage lung cancer patients will recur within 3-5 years after their tumor is completely removed by surgery, and we are encouraged that our model, especially when incorporating the IASLC Histologic Grading System, may lead to more accuracy in this regard,' said Harvey Pass, MD lead author of the abstract. 'Nevertheless, this work requires further external validation with other cohorts of Stage I lung cancer patients before it could be used clinically to determine who needs appropriate adjuvant therapy.'"

"Biodesix, Inc...announced today that two abstracts will be presented at the International Association for the Study of Lung Cancer (IASLC) 2023 World Lung Conference on Lung Cancer (WCLC). The first presentation showcases a new analysis of the large multi-center observational registry study INSIGHT...demonstrating the ability of the VeriStrat host immune classifier to predict response to immune checkpoint inhibitor (ICI) regimens in patients with advanced stage non-small cell lung cancer (NSCLC)....The second presentation details the performance of a pre-surgical, blood-based Risk of Recurrence test in three independent cohorts."

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...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...announced today that the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat^® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) has completed enrollment of 5,000 patients with non-small cell lung cancer (NSCLC). The study was designed to further validate the utility of the VeriStrat^® test, a novel predictive and prognostic blood-based host immune classifier, and its ability to support treatment decisions for patients with NSCLC across different therapeutic approaches....A recent analysis from this study has been accepted for presentation at the International Association for the Study of Lung Cancer (IASLC) World Conference on Lung Cancer in Singapore in September 2023."

"Biodesix, Inc...announced...that three new scientific abstracts will be presented as part of the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting including a poster presented by Friends of Cancer Research (FoCR) featuring genomic data contributed by Biodesix and other organizations...This poster highlights long term patient outcomes from the ctMoniTR Project, a study evaluating the prognostic value of changes in circulating tumor DNA (ctDNA) in patients treated with targeted therapies. The new data release indicates that ctDNA shows promise as an early endpoint to support drug development and regulatory decision-making."

"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."

"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."

"Biodesix, Inc...announced...that Wallace Akerley, MD, medical oncologist at the University of Utah Huntsman Cancer Institute, will present new interim data from the large multi-center prospective observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) at the Society for Immunotherapy of Cancer (SITC) 37th Annual Meeting."

"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."

P=NA | N=61 | "Biodesix, Inc...announced...will present the results of a retrospective analysis at the IASLC 2022 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer (#WCLC2022) on August 8, 2022 in Vienna, Austria....The analysis from Northwestern University included patients with advanced-stage non-small cell lung cancer (NSCLC) who received Immune Checkpoint Inhibitors (ICIs) as monotherapy or in combination with chemotherapy with PD-L1 <50%. Patients underwent Biodesix’s blood-based VeriStrat proteomic testing from 2016 to 2021. This data demonstrated that the VeriStrat test result was predictive of Progression Free Survival (PFS) and Overall Survival (OS) in patients with NSCLC with low or negative PD-L1 treated with ICIs."

"Royal Philips...announced it has teamed up with Biodesix, Inc...to incorporate the results of Biodesix’s Nodify Lung® blood-based lung nodule risk assessment testing into Philips Lung Cancer Orchestrator lung cancer patient management system....Solution adds proteomic analysis of blood-based biomarkers to Philips Lung Cancer Orchestrator to better assess the risk of lung nodule malignancy, enhancing decision-making for diagnosis and treatment."

"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."

"Biodesix, Inc...announced that it intends to develop a new novel minimal residual disease (MRD) test as a part of a master sponsored research agreement (MSRA) with Memorial Sloan Kettering Cancer Center (MSK). In addition, the MSRA between MSK and Biodesix also includes the potential future development of other diagnostic tests aimed at improving the treatment of cancer."

"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."

"Biodesix, Inc...announced that new data were published in the peer-reviewed journal, Diagnostics (Basel), in an article titled, 'Analytic and Clinical Validation of a Pan-Cancer NGS Liquid Biopsy Test for the Detection of Copy Number Amplifications, Fusions and Exon Skipping Variants.' This peer-reviewed publication further validates the GeneStrat NGS test and the use of multiple classes of tumor markers in circulating free nucleic acid analysis as a surrogate for tumor tissue biopsies."

"Biodesix...announced impactful data on the Primary Immune Response (PIR) test at the IASLC 2022 Targeted Therapies of Lung Cancer Meeting...The data showed that the Biodesix PIR test was predictive for survival outcomes when tested at baseline (HR=2.36, p=0.02) or 3 weeks after ICI treatment initiation (HR=3.53, p=0.001). Furthermore, the data suggested that patients classified as PIR-Resistant were more likely to experience rapid onset of immune related adverse events (irAE) when treated with ICIs (HR=2.40, p=0.08)...While the PIR test is not yet commercially available, it is being studied further in multiple ongoing clinical studies and is expected to launch commercially in 2023."

"PierianDx...today announced that it has partnered with Biodesix to provide its interpretation technology platform for use with the Biodesix newly launched GeneStrat NGS™ genomic test, a blood-based tumor profiling test to detect actionable mutations in patients with non-small cell lung cancer (NSCLC)....The IQLung strategy uses genomic profiling to detect actionable mutations in lung cancer, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner."

"Biodesix, Inc...announced today the national launch of its new GeneStrat NGS™ genomic test, a blood-based tumor profiling test. The 52-gene panel includes guideline recommended mutations to help physicians treating advanced- stage lung cancer patients identify targeted therapy mutations, such as EGFR, ALK, KRAS, MET, NTRK, ERBB2, and others, and delivers them in an expedited timeframe so patient treatment can begin sooner...The Company also announced the launch of its new IQLung™ Treatment Guidance Testing Strategy, which includes the new GeneStrat NGS and a broader view of each patient’s disease state."

"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."

"Biodesix, Inc...announced new interim data published from the large multi-center observational registry study INSIGHT (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects) (NCT03289780) utilizing its novel predictive and prognostic blood-based host immune classifier (the VeriStrat test) to stratify Immune checkpoint inhibition (ICI) treatment response in patients with advanced non-small cell lung cancer(NSCLC). The study, titled 'Real-world performance of blood-based proteomic profiling in first-line immunotherapy treatment in advanced stage non-small cell lung cancer,' was published in the Journal of Immunotherapy of Cancer (JITC)"

"Biodesix, Inc...announced that the company will co-present with Genentech...three posters at the 36th Annual Society for Immunotherapy of Cancer (SITC) Nov. 10 – 14, 2021 from research into diagnostic tests of treatment response of NSCLC patients to immune checkpoint inhibitor therapy."