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    TEST:
    LiquidHALLMARK®

    Company:
    Lucence
    Type:
    Laboratory Developed Test
    Related tests:
    Details
    Evidence

    News

    7ms
    Utility of an amplicon-based ctDNA platform for advanced cholangiocarcinomas (CCA) in asia. (ASCO 2024)
    Our advanced cholangiocarcinoma cohort of 56 patients from 5 Asian countries showed that an amplicon based ctDNA liquid biopsy platform overcomes the tissue-related challenges of genomic profiling specific to unresectable biliary tumors. We showed an 80. 4% discovery rate for any molecular alterations and a 8.
    PD(L)-1 Biomarker • BRCA Biomarker • IO biomarker • Circulating tumor DNA • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • FGFR2 (Fibroblast growth factor receptor 2) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • FGFR3 (Fibroblast growth factor receptor 3) • CDKN2A (Cyclin Dependent Kinase Inhibitor 2A) • SMAD4 (SMAD family member 4) • CDK6 (Cyclin-dependent kinase 6) • NTRK (Neurotrophic receptor tyrosine kinase) • CAMK2D (Calcium/Calmodulin Dependent Protein Kinase II Delta)
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    LiquidHALLMARK®
    9ms
    Lucence confirms comprehensive Medicare coverage for LiquidHALLMARK® and demonstrates sensitive detection of lung cancer biomarkers in prospective study (Lucence Press Release)
    "Lucence announced its receipt of confirmation that Medicare coverage for its LiquidHALLMARK® liquid biopsy test applies for patients with all stages of advanced solid tumors. This confirmation marks a significant milestone in promoting access to personalized oncology care on a broader scale."
    Medicare • Reimbursement
    |
    LiquidHALLMARK®
    1year
    Interim results from LIQUIK prospective study released at WCLC 2023 (Lucence Press Release)
    "Lucence announced that interim results for LIQUIK, a prospective international multicenter liquid biopsy study for lung cancer, will be reported at the IASLC 2023 World Conference on Lung Cancer (WCLC) on September 9-12, 2023...Key objectives are prospective comparisons of Lucence’s LiquidHALLMARK® amplicon-based assay to tissue-based next generation sequencing (NGS), as well as to an FDA-approved circulating tumor DNA (ctDNA) liquid biopsy test."
    Clinical data
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    LiquidHALLMARK®
    over1year
    Lucence announces CPT PLA code granted to LiquidHALLMARK™ (Lucence Press Release)
    "The American Medical Association (AMA) has granted a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for our LiquidHALLMARK™ liquid biopsy test. The CPT PLA code uniquely identifies the LiquidHALLMARK™ test for payors and providers, thus reducing administrative burdens and improving access."
    Medicare • Reimbursement
    |
    LiquidHALLMARK®
    over1year
    Amplicon-Based Liquid Biopsy Prospectively Detects More Tissue-Confirmed Guideline-Recommended Biomarkers in Lung Cancer (IASLC-WCLC 2023)
    LiquidHALLMARK identified numerically more tissue-confirmed G9 biomarkers compared to G360. Amplicon-based liquid biopsy technology complements tissue genotyping and provides additional utility for profiling metastatic NSCLC.
    Clinical • Liquid biopsy • Biopsy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    BRAF V600E • KRAS G12C • BRAF V600 • KRAS G12
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    Guardant360® CDx • LiquidHALLMARK®
    over1year
    Combining plasma and tissue next-generation sequencing provides optimal treatment selection for metastatic NSCLC: A comparative study. (ASCO 2023)
    Combining tissue and liquid NGS profiling provides the best treatment selection outcomes for patients with metastatic NSCLC. Our study highlighted that a quarter of NSCLC patients in Singapore would be identified for eligible targeted treatments from adopting a nationwide NGS testing approach, ideally tissue and liquid combined, to improve cancer services.
    PD(L)-1 Biomarker • IO biomarker • Next-generation sequencing • Metastases
    |
    EGFR (Epidermal growth factor receptor) • PD-L1 (Programmed death ligand 1) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    Idylla™ EGFR Mutation Test • LiquidHALLMARK®
    over1year
    Longitudinal tracking of ALK-positive lung cancer from plasma using circulating-tumor RNA and circulating-tumor DNA in the BRIGHTSTAR clinical trial. (ASCO 2023)
    We retrospectively analyzed 89 samples from 35 patients included in the BRIGHTSTAR clinical trial assessing local consolidative therapy (LCT) and brigatinib in patients with stage IV or recurrent Non-small Cell Lung Cancer and confirmed ALK rearrangement (NCT03707938)... We highlight that ALK fusions can be reliably detected in plasma of lung cancer patients and detectability of ALK fusions correlate with exposure to treatment. Analyzing ctRNA in addition to ctDNA improves sensitivity of fusion detection and is a highly promising strategy in this setting.
    Clinical • Circulating tumor DNA
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    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK rearrangement • ALK fusion
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    LiquidHALLMARK®
    |
    Alunbrig (brigatinib)
    over1year
    Assessing the utility of liquid biopsy for detecting actionable genetic mutations among indigenous Ghanaian women with metastatic breast cancer. (ASCO 2023)
    Liquid biopsy detected multiple actionable variants in Ghanaian women with breast cancer that a tissue-only workflow missed. cfDNA analysis featured less variations in sample preparation which is a key consideration in resource-limited settings. Further work will optimize NGS panels to account for novel ancestry specific variants.
    Clinical • BRCA Biomarker • Liquid biopsy • Metastases • Biopsy
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    BRCA2 (Breast cancer 2, early onset) • MSI (Microsatellite instability) • GNAQ (G Protein Subunit Alpha Q) • BRCA (Breast cancer early onset) • ARAF (A-Raf Proto-Oncogene) • GATA3 (GATA binding protein 3)
    |
    BRCA mutation
    |
    LiquidHALLMARK®
    over1year
    Singapore’s Lucence secures US Medicare approval for its cancer tests (Business Times)
    "...Lucence has secured approval for its Singapore-invented cancer tests from Medicare, a US government-funded healthcare insurance programme primarily for people aged 65 years and older...The programme covers about 64 million people in the US and will reimburse patients for using Lucence’s blood test, LiquidHallmark, to detect lung cancer. In the US, there are about 150,000 new cases a year of advanced lung cancer in patients aged 65 and above."
    Medicare • Reimbursement
    |
    LiquidHALLMARK®
    over1year
    LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P=N/A; Recruiting --> Active, not recruiting | Trial completion date: Nov 2023 --> Dec 2024
    Trial completion date • Enrollment closed
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 fusion • NTRK fusion
    |
    LiquidHALLMARK®
    over1year
    Lucence announces Medicare reimbursement decision for LiquidHALLMARK® assay in lung cancer (Lucence Press Release)
    "Lucence announced...that Palmetto GBA, a Medicare administrative contractor and leader in evaluating molecular diagnostic technology through its laboratory technology assessment group for the Molecular Diagnostics Services program (MolDX), has finalized a foundational Local Coverage Determination (LCD) for the LiquidHALLMARK assay. The LCD covers all nine NCCN guideline-recommended molecular biomarkers in advanced lung cancer patients using LiquidHALLMARK."
    Medicare • Reimbursement
    |
    LiquidHALLMARK®
    2years
    Lucence shares promising interim data from LIQUIK prospective study at ISLB 2022 (Lucence Press Release)
    "Lucence...is sharing promising interim results from the prospective multicenter validation study of its LiquidHALLMARK ctDNA liquid biopsy assay for the detection of guideline-recommended biomarkers in metastatic lung cancer. Results from the study— LIQUIK, or Liquid Biopsy for Detection of Actionable Genomic Biomarkers in Patients with Advanced Non-small Cell Lung Cancer—were shared as part of a poster presentation at the 4th Annual Congress of the International Society of Liquid Biopsy in Miami, Florida."
    Clinical data
    |
    LiquidHALLMARK®
    2years
    Lucence taps Omnigen to distribute liquid biopsy tests in Turkey (Genomeweb)
    "Precision oncology firm Lucence said Tuesday that it has entered a new partnership with laboratory diagnostics distributor Omnigen Medical Products to expand access to its liquid biopsy tests for cancer patients in Turkey...Under the terms of the agreement, Omnigen will market tests, including Lucence's LiquidHallmark next-generation sequencing assay, to Turkish hospitals and clinicians as part of its existing business as a distributor of genetic testing and molecular and pathological equipment."
    Licensing / partnership
    |
    LiquidHALLMARK®
    2years
    Liquid biopsy NGS test identifies actionable DNA mutations from CSF specimens of lung cancer patients (ESMO Asia 2022)
    Front Oncol. Published online October 4, 2021.
    Clinical • Liquid biopsy • Next-generation sequencing
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR exon 19 deletion
    |
    LiquidHALLMARK®
    2years
    Lucence, National Cancer Centre Singapore to study liquid biopsy assay in prostate cancer (Genomeweb)
    "Precision oncology company Lucence...has entered into a research collaboration with the National Cancer Centre Singapore to evaluate the company's LiquidHallmark assay for improving prostate cancer treatment in Asian men...The collaborators plan to conduct a prospective study to better define the clinical utility of LiquidHallmark in guiding treatment decisions and achieving therapy outcomes among men with metastatic castration-resistant prostate cancer."
    Licensing / partnership • New trial
    |
    LiquidHALLMARK®
    2years
    Clinical Validation of a Promising New Amplicon-Based Liquid Biopsy Platform for Detection of Guideline Recommended Biomarkers in Metastatic NSCLC (IASLC-NACLC 2022)
    Liquid biopsy has been very valuable in the identification of guideline-recommended biomarkers in metastatic non-squamous NSCLC. Our analysis revealed greater identification of guideline-recommended biomarkers with LiquidHALLMARK in comparison to Guardant360 thus far. Given the encouraging results, LIQUIK-01 recruitment, further investigations and analysis will continue.
    Clinical • Liquid biopsy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2)
    |
    BRAF V600E • KRAS G12C • BRAF V600 • KRAS G12
    |
    Guardant360® CDx • LiquidHALLMARK®
    over2years
    Lucence presents data at 2022 world conference on lung cancer (WCLC) supporting utility of amplicon-based liquid biopsy (Lucence Press Release)
    "Lucence will present new data at the upcoming IASLC 2022 World Conference on Lung Cancer on August 6-9, 2022, highlighting novel applications of its ultrasensitive amplicon-based next generation sequencing technology in the detection and treatment of lungLucence recently announced the publication of a validation study for its flagship LiquidHALLMARK ctDNA Liquid Biopsy Assay. The study, published in PLOS ONE, establishes LiquidHALLMARK’s performance and identifies actionable biomarkers in 70% of lung cancer patients. In addition to showing high sensitivity of both LiquidHALLMARK and Lucence’s AmpliMark amplicon next-generation sequencing (NGS) platform, external validation with cobas® EGFR Mutation Test v2 for lung cancer specimens demonstrated an overall concordance of 84.00% with a 100% concordance rate for EGFR variants above 0.4% VAF. cancer."
    Clinical data
    |
    cobas® EGFR Mutation Test v2 • LiquidHALLMARK®
    over2years
    Peripheral T-Cell Receptor Repertoire Profiling in Non-small Cell Lung Cancer Using an Amplicon-Based Sequencing Assay (IASLC-WCLC 2022)
    Our preliminary data demonstrates the differences in peripheral TCR repertoires by molecular subtypes of NSCLC, and treatment status. Compared to tumor infiltrating TCR repertoires, the determination of peripheral TCR repertoires can be done non-invasively and serially. The TCR sequencing Method can complement plasma-based cfDNA sequencing through serial testing which provides insights into clonal diversity evolution and patient’s immunological status.
    IO biomarker
    |
    EGFR (Epidermal growth factor receptor) • TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8)
    |
    TP53 mutation • EGFR mutation • EGFR expression • EGFR positive
    |
    LiquidHALLMARK®
    over2years
    Retrospective Analysis of BRCA1/2 Alterations in Advanced NSCLC Using An Amplicon-based NGS Liquid Biopsy Assay (IASLC-WCLC 2022)
    Ultrasensitive liquid biopsy enables detection of pathogenic BRCA1/2 alterations in plasma cfDNA of lung adenocarcinomas, despite low VAFs. Retrospective analysis suggests a difference in cfDNA mutational profiles in BRCA1/2 mutants, warranting further investigation on the role of BRCA1/2, HRD, and correlation with ICI treatment response in lung adenocarcinoma.
    Retrospective data • BRCA Biomarker • IO biomarker • Liquid biopsy • Next-generation sequencing
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RET (Ret Proto-Oncogene) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    KRAS mutation • BRCA2 mutation • BRCA1 mutation • EGFR mutation • BRAF mutation • HRD • BRCA wild-type • MET mutation • BRCA2 deletion • BRCA1 deletion • HRD + BRCA1 mutation • BRCA mutation • BRCA1 positive • BRCA2 positive
    |
    LiquidHALLMARK®
    over2years
    LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P=N/A; Trial primary completion date: Mar 2022 --> Dec 2022
    Trial primary completion date • Liquid biopsy
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 fusion • NTRK fusion
    |
    LiquidHALLMARK®
    over2years
    Lucence announces publication of validation study for LiquidHALLMARK ctDNA liquid biopsy assay (Lucence Press Release)
    "Lucence, the precision oncology company pioneering ultrasensitive liquid biopsy tests, is announcing the recent publication of a study validating its LiquidHALLMARK ctDNA liquid biopsy assay in PLOS ONE, a peer-reviewed, open access scientific journal. The study results establish high sensitivity, specificity, accuracy and precision of LiquidHALLMARK, based on the AmpliMark amplicon-sequencing platform, and support compelling clinical applications for its use."
    Clinical data
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    LiquidHALLMARK®
    over2years
    Analytical and clinical validation of an amplicon-based next generation sequencing assay for ultrasensitive detection of circulating tumor DNA. (PubMed, PLoS One)
    Among ctDNA-positive lung cancers, 72.5% harbored at least one biomarker with a guideline-approved drug indication. These results establish the high sensitivity, specificity, accuracy, and precision of the LiquidHALLMARK assay and supports its clinical application for blood-based genomic testing.
    Journal • Next-generation sequencing • Circulating tumor DNA
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    EGFR (Epidermal growth factor receptor) • MSI (Microsatellite instability)
    |
    EGFR mutation
    |
    cobas® EGFR Mutation Test v2 • LiquidHALLMARK®
    over2years
    A cell-free RNA-based next-generation sequencing (NGS) assay for the detection of actionable gene fusions in patients with non–small cell lung cancer (NSCLC). (ASCO 2022)
    This novel cfRNA assay can detect actionable gene fusions and exon skipping events in liquid biopsies with high sensitivity. Combining cfRNA with more routine cfDNA testing can increase the total actionable diagnostic information from non-invasive testing in NSCLC patients where tissue samples are lacking, especially for gene fusions not amenable to detection in cfDNA.
    Clinical • Next-generation sequencing
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    BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • RET (Ret Proto-Oncogene) • FGFR2 (Fibroblast growth factor receptor 2) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • FGFR3 (Fibroblast growth factor receptor 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • NRG1 (Neuregulin 1) • CD74 (CD74 Molecule) • TACC3 (Transforming acidic coiled-coil containing protein 3)
    |
    MET exon 14 mutation • FGFR3-TACC3 fusion • FGFR2 fusion • ALK fusion • NRG1 fusion • FGFR3 fusion
    |
    LiquidHALLMARK®
    over2years
    Detection of homologous recombination deficiency (HRD) in cell-free DNA (cfDNA) using an amplicon-based next-generation sequencing (NGS) assay. (ASCO 2022)
    LOH detection in cfDNA provides additional diagnostic yield of HRD+ status in multiple cancer types, even in the absence of pathogenic HR gene alterations. Further clinical studies to evaluate the utility of HRD detection in cfDNA using LOH and to determine concordance with tumor tissue are ongoing.
    PARP Biomarker • BRCA Biomarker • Next-generation sequencing
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • ARID1A (AT-rich interaction domain 1A) • BAP1 (BRCA1 Associated Protein 1) • PALB2 (Partner and localizer of BRCA2) • CDK12 (Cyclin dependent kinase 12) • ATRX (ATRX Chromatin Remodeler) • BRCA (Breast cancer early onset) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD51D (RAD51 paralog D) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1) • MRE11A (MRE11 homolog, double strand break repair nuclease) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCL (FA Complementation Group L) • XRCC2 (X-Ray Repair Cross Complementing 2) • FANCG (FA Complementation Group G) • FANCC (FA Complementation Group C)
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    HRD • PALB2 mutation • CDK12 mutation • BRCA mutation
    |
    LiquidHALLMARK®
    over2years
    Early detection of cancer using cell-free DNA (cfDNA) size analysis on a multiplexed amplicon-based next-generation sequencing (NGS) platform. (ASCO 2022)
    Our analysis shows that it is feasible to derive meaningful cfDNA fragment size information from amplicon-based NGS data. Importantly, relative fragment size distributions observed in cancer and healthy plasma samples by this method are concordant with alternate target capture methods. Fragment size ratios derived from relatively small, targeted amplicon panels are a novel feature that, combined with other molecular and clinical features, can enhance non-invasive methods of cancer detection.
    BRCA Biomarker • Next-generation sequencing
    |
    BRCA (Breast cancer early onset)
    |
    LiquidHALLMARK®
    almost3years
    Lucence’s LiquidHALLMARK liquid biopsy assay expands to include cfRNA (Lucence Press Release)
    "Lucence...is announcing the availability of an expanded version of its flagship LiquidHALLMARK liquid biopsy assay that includes both cell-free DNA (cfDNA) and cell-free RNA (cfRNA) profiling. LiquidHALLMARK cfDNA and cfRNA is currently available to US oncologists as a laboratory developed test and is being utilized by physicians at NCI-designated centers across the country."
    Clinical
    |
    LiquidHALLMARK®
    almost3years
    LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P=N/A; Trial primary completion date: Sep 2021 --> Mar 2022
    Trial primary completion date • Clinical • Liquid biopsy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 fusion • NTRK fusion
    |
    LiquidHALLMARK®
    3years
    Lucence, Veteran's Affairs Health Care System launch liquid biopsy screening study (Precision Medicine Online)
    "Lucence and the VA Palo Alto Health Care System are launching a prospective observational study to evaluate the use of the sequencing-based LiquidHallmark liquid biopsy assay in a screening context...The study will compare the sensitivity and specificity of positron emission tomography-computed tomography (PET/CT) alone versus PET/CT in combination with LiquidHallmark in detecting lung cancer nodules between six and 20 millimeters in size, among high-risk patients with at least one lung nodule suspected of malignancy."
    Licensing / partnership • New trial
    |
    LiquidHALLMARK®
    over3years
    [VIRTUAL] Serial circulating tumor (ct)-DNA alterations using amplicon-based next-generation sequencing (NGS) to identify resistance mechanisms to immune checkpoint inhibitors (ICIs) for metastatic urothelial carcinoma (mUC) (ESMO 2021)
    Study of serial ctDNA alterations during therapy may provide a non-invasive method of exploring mechanisms of resistance to ICI. Pts with mUC at DFCI who had ≥2 ml plasma available pre- and post-ICI or cisplatin-based chemotherapy (chemo) were eligible... ctDNA alterations were detected in 96% of pre/post-ICI samples overall. Clearance of TP53 alterations during ICI therapy was associated with response, while emergence of BRCA1/2 or PI3KCA variants appeared to be associated with resistance. Exploration of therapeutic combinations of ICI with PARP and PI3K/Akt inhibition in mUC may be warranted.
    Checkpoint inhibition • PD(L)-1 Biomarker • PARP Biomarker • BRCA Biomarker • IO biomarker • Next-generation sequencing
    |
    TP53 (Tumor protein P53) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • FGFR2 (Fibroblast growth factor receptor 2) • CCND2 (Cyclin D2)
    |
    TP53 mutation • PIK3CA mutation
    |
    LiquidHALLMARK®
    |
    cisplatin
    over3years
    LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P=N/A; Not yet recruiting --> Recruiting
    Enrollment open
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 fusion • NTRK fusion
    |
    LiquidHALLMARK®
    almost4years
    LIQUIK: LIQUId Biopsy for Detection of Actionable Genomic BiomarKers in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (clinicaltrials.gov)
    P; N=200; Not yet recruiting; Sponsor:Lucence Health Inc.
    New trial • Clinical
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    ROS1 fusion • NTRK fusion
    |
    LiquidHALLMARK®