COMPANY:

Biodesix

"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."

"Biodesix, Inc...today announced that multiple data presentations will occur at the 2021 annual CHEST virtual conference. Presentations will include newly emerging 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 incorporation of this blood-based test in the management of patients with newly detected lung nodules modified physician behavior. The prospectively collected data show the ability to reduce unnecessary invasive biopsies and surgeries, through incorporation of the Nodify XL2 test in clinical practice...Biodesix, will present a new analysis of the Nodify CDT® test on the PANOPTIC study population, evaluating the autoantibody profile of patients diagnosed with lung cancer."

"An independent study presented by Leeseul Kim, MD of AMITA Health Saint Francis Hospital Evanston, IL, demonstrated that blood-based proteomic testing (Biodesix, Inc.) predicts survival outcomes in patients with non-small cell lung cancer (NSCLC) receiving an immune checkpoint inhibitor (ICI)-based regimen; A study presented by Edgardo Santos, MD, Florida Precision Oncology, Aventura, FL, demonstrated that the blood-based GeneStrat® test, focusing specifically on the KRAS G12C/V/D+ testing for this analysis, delivered results to ordering clinicians in under 30 hours on average in two large patient cohorts...Expedited time-to-treatment for patients with actionable driver mutations, now including people with NSCLC that have the KRAS G12C mutation (drug Lumakras™ (sotorasib), Amgen, Inc.) will improve patient access and overall outcomes..."

"Today Biodesix announced that the Accreditation Committee of the College of American Pathologists (CAP) and British Standards Institute (BSI) on behalf of International Organization for Standardization (ISO) recently awarded both CAP accreditation and ISO 13485:2016 certification to the Biodesix Laboratory located in DeSoto, Kansas, based on results of two independent inspections conducted by CAP and BSI inspectors."

"Biodesix, Inc...today announced in partnership with Seer, Inc...to present the newest trends in proteomics for biomarker discovery and translational research...The webinar entitled 'A New Era in Precision Medicine - Uncovering the Depth & Breadth of the Plasma Proteome with Novel Proteomic Technologies' will be presented...The webinar will include an overview of Seer’s Proteograph™ Product Suite, which uses proprietary engineered nanoparticles to survey plasma proteins, allowing researchers to identify and quantitate proteins across the dynamic range of the proteome."

"Biodesix, Inc...announced a strategic partnership with Datavant...Datavant provides solutions to help protect, match, and share health data. Through this partnership, Biodesix will anonymize the lung cancer portion of their expansive sample and data biobank using Datavant’s proprietary tokenization process and connect it to multiple real-world data sets while compliantly and securely protecting patient privacy."

"Biodesix…and Addario Lung Cancer Medical Institute (ALCMI) today announced they will present on the progress of ‘Biomarker Analysis in High PD-L1 Expressing NSCLC Patients Treated With PD-1/PD-L1 Based Therapy With or Without the Addition of Platinum Based Chemotherapy (BEACON-Lung).’ The BEACON-Lung study aims to evaluate biomarkers to predict overall survival and early progression outcomes in treatment-naïve advanced stage non-small cell lung cancer (NSCLC) patients with high PD-L1 expression. The first patient participant enrolled in the study this week."

"Biodesix, Inc...has announced their plan to add a blood-based 52-gene next generation sequencing (NGS) test to their portfolio of molecular testing based on a recent publication. Of critical importance, the publication, 'argeted Next-Generation Sequencing of Liquid Biopsy Samples from Patients with NSCLC,' in Diagnostics showed that the rapid liquid biopsy testing was able to detect actionable genomic alterations in patients with non-small cell lung cancer (NSCLC) with an unmatched turnaround time of only 72 hours."

"Biodesix, Inc...today announced that three abstracts from multiple clinical studies will be showcased at the 2021 American Association for Cancer Research (AACR) Annual Meeting being held virtually April 10-15, 2021 and May 17-21, 2021. Findings from these studies address the utility of physicians using blood-based proteomic testing as an approach to interpret each patient’s immune response to cancer, which can help guide treatment decisions…Abstract #662: Longitudinal blood-based proteomic testing in advanced non-small cell lung cancer…demonstrates that the VeriStrat® blood-based immune profiling test is capable of monitoring changes in disease state and patient immune response for patients with advanced NSCLC."

"Biodesix, Inc...today announced that the United States Patent and Trademark Office (USPTO) has issued two patents that will enhance its ability to develop blood-based immunotherapy and pipeline testing strategies. These developments further improve Biodesix’s ability to offer rapid, accurate assessment of patients, which guide physician treatment strategies for their cancer patients."

“Biodesix, Inc…announced an agreement with HiberCell…to further the development of an enzyme-linked immunosorbent assay (ELISA) as a companion diagnostic in future registrational trials in breast cancer for Imprime PGG programs. Terms of the partnership were not disclosed…Biodesix will continue its leadership in clinical proteomics by developing a companion diagnostic to select patients for enrollment in HiberCell’s future registrational clinical trials."

"Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, recently published data from three clinical studies, which found important new information on diagnosis and management of lung nodules. Data from these studies, which are being presented at the American College of Chest Physicians (CHEST) annual meeting, demonstrate the value of the Nodify Lung™ testing strategy and confirm previously reported performance of the Nodify XL2® and Nodify CDT™ tests."

"Addario Lung Cancer Medical Institute (ALCMI) and Biodesix, Inc. today announced they will begin an observational study to prospectively evaluate the clinical utility of biomarkers, including the proteomic Primary Immune Response (PIR) test, for front-line non-small cell lung cancer (NSCLC) patients receiving immunotherapy with and without the addition of systemic platinum-based chemotherapy who have high expression of program death ligand-1 (PD-L1) on their tumor cells."

“Biodesix, Inc…announced the publication of research findings on a diagnostic test capable of generating valuable data to help guide the treatment of patients with advanced non-small cell lung cancer (NSCLC). The paper, entitled ‘A serum protein classifier identifying patients with advanced non-small cell lung cancer who derive clinical benefit from treatment with immune checkpoint inhibitors,’ concludes that a proteomic based diagnostic test can provide clinically significant information to predict outcomes of immune checkpoint inhibitor therapy and guide treatment choices made by physicians for patients with advanced NSCLC.”