Gary Pestano, Ph.D., Chief Development Officer and Robert W. Georgantas III, Ph.D., Chief Scientific Officer & Kieran O'Kane, Chief Commercial OfficerBiodesix (NASDAQ: BDSX), a data-driven diagnostic solutions company, is transforming the standard of care and improving outcomes through personalized diagnostics with a focus on lung cancer. The company's proprietary platform, Diagnostic Cortex® AI, optimizes the discovery of clinical diagnostic tests from multiple technologies, including genomics, transcriptomics, proteomics, and radiomics. The platform combines blood-based biological information related to the tumor, immune response, and host-status with clinical and radiomic data to interpret the holistic disease state of each patient or clinical dataset.
Commercializing Complex and Multiplexed Proteomic- Based Diagnostic Tests
Biodesix has been an innovator in the assay of high-plex proteomics, as well as taking that information to the development of clinically relevant diagnostic tests. They are one of the few companies that have been able to commercialize complex, and multiplexed proteomic-based diagnostic tests.
"We understand the importance of the circulating human proteome as a vital component of the disease," says Kieran O'Kane, Chief Commercial Officer at Biodesix. "High-plex assays combine different proteins into a single diagnostic test to ensure better outcomes."
The three clinical proteomic tests Biodesix offers use technologies such as Liquid Chromatography Mass Spectrometry (LC-MS), MALDI-ToF Mass Spectrometry, and Enzyme-Linked Immunosorbent Assay (ELISA.
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We continue to innovate in the diagnostic AI space by inventing methods to champion the use of transparent and explainable AI in diagnostic tests
Biodesix has developed the DeepMALDI® system as a proprietary, high-density, matrix-assisted laser desorption/ ionization time-of-flight (MALDI-ToF) mass spectrometry (MS) technology. It produces high-quality protein data content for the discovery of diagnostic tests with clinical utility. ELISA is used to detect and quantify the presence of antibodies and proteins in blood samples by exploiting the interaction between antigen and antibody.
"We are experts at profiling patients' immune response to their cancer with blood-based proteomic solutions in addition to providing genomic insights into the tumor," says Gary Pestano, Ph.D., Chief Development Officer at Biodesix, Inc. "Our technologies and machine learning expertise allow us to identify clinically relevant proteomic differences in patient populations to help guide treatment strategy."
A prime example of how Biodesix assists physicians in diagnostic and therapeutic decision-making is its Nodify® testing, which addresses the unmet needs in pulmonary nodule management. There is an apparent need for better tools to assess the risk of malignancy of pulmonary nodules to avoid unnecessary invasive procedures and the risk of a delayed diagnosis. In a recent sub-group Interim analysis of the prospective INSIGHT study, the investigators showed that patients with a host immune classifier (HIC)-cold proteomic signature should not receive I-O monotherapy regardless of PD-L1 IHC staining status (Rich et al. 2021 JITC).
Biodesix has successfully gained regulatory approvals and reimbursement for all its clinical proteomic tests on the market.
Assisting Physicians in Diagnostic and Therapeutic Decision-Making
One of the major advantages of proteomics technology is the large number of proteins assayed, allowing for the discovery of multiple potential biomarker proteins in a single dataset. But this level of data requires AI/ML-based statistics to recognize patterns. Biodesix achieves this by leveraging AI for the discovery of diagnostic tests, as well as for the basis of a commercial test.
One problem with AI-based tests is that they have been considered "black boxes"—impossible to explain. Biodesix believes that it is imperative for physicians and patients to understand why a diagnostic test is giving them a certain answer.
"We continue to innovate in the diagnostic AI space by inventing methods that pioneer the use of transparent and explainable AI in diagnostic tests," says Robert W. Georgantas III, Ph.D., Chief Scientific Officer. "We are currently the only diagnostic company breaking the AI black box so that physicians and patients can see exactly how our tests work and make diagnostic recommendations."
To successfully ensure the validation of discovered diagnostic tests, Biodesix has taken exhaustive measures in everything, from sample collection methods to the structure of the Diagnostic Cortex AI platform, to ensure that tests validate in blinded independent patient cohorts.
"For over 15 years, we have focused on developing proprietary computational techniques for each diagnostic test that is discovered by the Diagnostic Cortex platform," says O'Kane.
Our technologies and machine learning expertise allow us to identify clinically relevant proteomic differences in patient populations to help guide treatment strategy
Platform. Partnership. Technology.
A Biodesix key strength is the variety of platforms and technologies available to them. Not tied to any platform, it can focus on the unique needs of a particular customer and use the most appropriate platform as a solution.
Biodesix collaborates with thought leaders to identify unmet needs or opportunities for improvement. Platform proteomic partners include Bruker and SEER. Active collaborations with leading academic institutions, such as Memorial Sloan Kettering (MSK), contribute to Biodesix's successes.
Biodesix has successfully gained regulatory approvals and reimbursement for all five clinical tests (proteomic and genomic) currently on the market. It continuously incorporates new market insights and patient data in a data-driven learning loop to enhance its platform. Insights from development and approval are used to inform pharma clients and clinical teams about why the development of a proteomic test is not a risk to their submission.
Biodesix Announces Two Presentations on Lung Cancer Treatment Guidance Tests at the IASLC 2023 World Lung Conference on Lung Cancer
Saturday, September 30, 2023
New data highlights two novel proteomic tests that support treatment decision making in patients with non-small cell lung cancer (NSCLC):
• Expanded analysis of the VeriStrat® host immune classifier’s ability to predict immune checkpoint inhibition (ICI) response in patients with advanced stage NSCLC
• The ability of the Risk of Recurrence pipeline test to stratify time to recurrence and overall survival in patients with stage I NSCLC
BOULDER - Biodesix, Inc. (Nasdaq: BDSX), 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 (Clinical Effectiveness Assessment of VeriStrat® Testing and Validation of Immunotherapy Tests in NSCLC Subjects, NCT03289780) 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 INSIGHT trial, which has recently achieved its enrollment target of 5,000 patients with Non-Small Cell Lung Cancer (NSCLC), had previously generated data indicating that patients with a PD-L1 status of ≥50%, categorized as Host Immune Classifier Cold (HIC-C) or VeriStrat Poor, exhibited improved median overall survival when treated with Immune Checkpoint Inhibitors (ICI) in combination with chemotherapy, compared to those receiving ICI alone. A more extensive analysis now substantiates these findings and concludes that patients with a PD-L1 status of <50%, identified as Host Immune Classifier Hot (HIC-H) or VeriStrat Good, demonstrated similar overall survival outcomes whether treated with ICI alone or in combination with chemotherapy.
“These findings highlight the importance of characterizing a patient’s immune response to lung cancer to guide immunotherapy treatment decisions,” said Wallace Akerley, MD, principal investigator of the INSIGHT study. “The growing body of evidence shows the VeriStrat test is complementary to current standard of care and its use would improve overall patient outcomes by identifying subsets of patients who would benefit from Veristrat-directed selection of immunotherapy regimen.”
The second presentation focuses on the evaluation of a pre-surgical, blood-based Risk of Recurrence test across three independent cohorts. Patients diagnosed with early-stage lung cancer generally have positive outcomes, but a considerable number experience recurrence, leading to a less favorable prognosis. The primary objective of the test is to identify patients with a heightened likelihood of recurrence, enabling them to be considered for more aggressive treatment or enhanced surveillance.
In this initial validation study, approximately 800 patients with Stage I Non-Small Cell Lung Cancer (NSCLC) were assessed. The study successfully categorized patients into three distinct risk groups (high, intermediate, or low risk of recurrence) based on their proteomic profiles. Additionally, the incorporation of adenocarcinoma grade, a well-established risk factor for recurrence, contributed to enhancing the test's performance.
“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 Announces New Master Collaborative Research Agreement with Leading US Cancer Center
Monday, April 22, 2024
LOUISVILLE -Biodesix, Inc. (Nasdaq: BDSX), 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. Bio-Rad will provide its industry-leading digital PCR assay technology in support of this important work.
The collaborators, represented by Dr. Howard Scher (MSK) and Dr. Gary Pestano (Biodesix), will share an update at the 31st International Precision Medicine Tri-Con meeting (PMTC) on March 25: “An Industry | Academic Collaboration Framework Focused on Novel Diagnostic Test Development in Oncology”.
“The expansion of our previous master sponsored research agreement (MSRA) into a master collaborative research agreement with MSK is a significant milestone for Biodesix and for biomarkers in oncology diagnostics. Biodesix looks forward to co-developing and validating new test concepts under these agreements,” said Scott Hutton, CEO, Biodesix.
“We look forward to working with Biodesix to develop the next generation of highly multiplexed digital PCR assays as part of our expanding oncology offering,” said Simon May, EVP and President of Life Sciences at Bio-Rad Laboratories. “Bio-Rad provides the leading solution for digital PCR, and we are committed to providing oncology researchers and commercial partners with technologies that enable everything from biomarker discovery to clinical trials and patient monitoring of minimal residual disease.”
Biodesix to Present at Two Investor Conferences in September
Tuesday, September 24, 2024
LOUISVILLE, Colo - Biodesix, Inc. (Nasdaq: BDSX), today that members of the Biodesix management team will present at two upcoming investor conferences:
Lake Street Capital Markets 8th Annual Best Ideas Growth Conference
Date: Thursday, September 12, 2024
Location: The Yale Club, New York, NY
Presenter: Scott Hutton, CEO of Biodesix
Colorado BioScience Association (CBSA) Rocky Mountain Life Sciences Investor and Partnering Conference
Dates: September 12-13, 2024
Location: Beaver Run Resort & Conference Center, Breckenridge, CO
Presenter: Robin Cowie, CFO of Biodesix
