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June 3rd, 2017
ASCO 2017: MSKCC to Present Prospective Study of Plasma ctDNA in NSCLC cancers matched to targeted therapy.

Resolution Bioscience, Inc. is proud to announce the presentation by collaborators at Memorial Sloan Kettering Cancer Center and Northern Cancer Institute, University of Sydney at today's ASCO conference in Chicago

Results: Forty-one pts were prospectively accrued. Plasma ctDNA detected an oncogenic driver in 39% (16/41) of pts, of whom 17% (7/41) were matched to targeted therapy; including pts matched to clinical trials for HER2 exon 20 insertionYVMA, BRAF L597Q and MET exon14. Mean turnaround time for plasma was 7 days (4-12) and 28 days (20-43) for tissue. Plasma ctDNA was detected in 56% (23/41) of pts; detection was 40% (8/20) if blood was drawn on active therapy and 71% (15/21) if drawn off therapy, either at diagnosis or progression (Odds ratio 0.28, 95% CI 0.06 - 1.16; p = 0.06). All pts had concurrent tissue NGS; of the 10 samples resulted, there was 100% driver concordance between tissue and plasma in pts drawn off therapy.

Conclusions: In pts who were driver unknown or who had clinical concern for tumor heterogeneity, plasma ctDNA NGS identified a variety of oncogenic drivers with a short turnaround time and matched them to targeted therapy. Plasma ctDNA detection was more frequent at diagnosis of metastatic disease or at progression. A positive finding of an oncogenic driver in plasma is highly specific, but a negative finding may still require tissue biopsy.

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June 3rd, 2017
ASCO 2017: Northwestern University and Vanderbilt to Present Plasma-based Longitudinal Monitoring of Mutations and T-cell Repertoire in Small Cell Lung Cancer.

Resolution Bioscience, Inc. is proud to announce the presentation by collaborators at Vanderbilt University School of Medicine and Northwestern University School of Medicine at today's ASCO conference in Chicago

Results: We detected somatic, disease-associated mutations in 85% of patient samples (23/27) with allele frequencies of cfDNA ranging from ≤0.5% to ≥85%. The most commonly mutated genes were TP53 (17/27 patients) and RB1 (10/27 patients). We detected 87 unique genomic alterations in 12 different genes (in addition to TP53 and RB1 these included PTEN, NOTCH1-4, MYC, MYCL1, PIK3CA, KIT, and BRAF). The observed mutant allele frequencies in longitudinal samples tracked with treatment response, including cases in which cfDNA allele frequencies increased before clinical evidence of relapse. Longitudinal monitoring of T cell repertoire demonstrated both variability between patients and sequential changes during therapy, including one case of decreased T cell numbers accompanying disease relapse.

Conclusions: As the field of immuno-oncology matures, we anticipate that coupled determination of T cell repertoire together with cfDNA monitoring will merge into a clinically useful “molecular image” of each patient’s disease status and real-time host immune response.

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June 3rd, 2017
Detection of HRD gene mutations and copy number changes in cfDNA from prostate cancer patients.

Recent genomic surveys of prostate cancer have identified somatic mutations in metastatic castration-resistant prostate cancer (mCRPC). In this study, we examined mCRPC patients for AR aberrations and mutations in the HRD (homologous recombination DNA-repair) pathway which may confer platinum or PARP inhibitor sensitivity. Methods: A novel targeted-hybrid-capture NGS assay capable of identifying deleterious mutations, copy number amplification and gene copy loss, was applied to circulating, cell-free DNA (cfDNA) extracted from plasma samples from 20 mCRPC patients. Samples were collected between 3/2010 – 10/2015 and stored at -20C. The gene panel used in the assay included AR and several genes in the HRD pathway — ATM, BARD1, BRCA1, BRCA2, BRIP1, CDK12, CHEK2, FANCA, HDAC2, NBN, PALB2, and RAD51. Sequencing libraries created with the cfDNA extracted from 2.8-4 mLs of plasma had an average unique read coverage depth of 2282 genome equivalents (range 445 – 5136, median 2181). Results: Somatic variations were observed in 17 of the 20 samples analyzed. Copy number variation (CNV) was observed in 11 samples. AR amplification, linked to resistance to abiraterone and enzalutamide, was observed in 30% (6) of samples. Canonical AR ligand binding domain mutations, such as T787A and L702H were also detected. ATM, BRCA1, BRCA2, HDAC2, and FANCA gene deletions were also detected, as well as frameshift, nonsense, and other deleterious mutations in HRD genes. Significant CNV in multiple genes was observed in at least 5 patient samples. Mutations were detected across the entire collection date range, speaking to the robustness of cfDNA. Conclusions: Non-invasive tumor mCRPC genotyping appears to be feasible. The ability to detect HRD gene alterations suggests cfDNA testing may be suitable for the detection of HRD pathway defects and overall genome instability.

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April 4, 2017
Vanderbilt and Resolution Bioscience to present at AACR 2017 on longitudinal monitoring of cell-free DNA in patients with small cell lung cancer

Resolution Bioscience, Inc. is proud to announce the presentation by collaborators at Vanderbilt University School of Medicine and Northwestern University School of Medicine at today's AACR conference in Washington D.C.

Results: We detected somatic, disease-associated mutations in the cfDNA of 78% of patient samples (21/27). The allele frequency of cfDNA ranged from ≤0.5% to ≥85%. The most commonly mutated genes were TP53 and RB1, which were found in 17/27 and 10/27 samples, respectively. We also detected single nucleotide variants in PIK3CA (3/27) and PTEN (1/27) as well as copy number variants in MYC and MYCL1 (2/27). The observed mutant allele frequencies in longitudinal samples tracked closely with treatment responses. Strikingly, we found instances where the assay detected the reappearance of tumor-associated markers several weeks before clinical evidence of relapse was detected.

Conclusions: cfDNA sequencing allows for improved monitoring of disease burden, depth of responses to treatment, and timely warning of disease relapse in patients with SCLC.

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September 7, 2016
Resolution Bioscience Announces Collaboration on Liquid Biopsies with Frederick National Laboratory for Cancer Research

Resolution Bioscience, Inc. today announced that it has entered into an agreement with the Leidos Biomedical Research Inc, which operates the Frederick National Laboratory for Cancer Research, to evaluate Resolution Bio's ctDx novel chemistry and proprietary bioinformatics data analysis pipeline. The agreement includes training of the Frederick National Laboratory's scientific staff, an effort that is already underway, as well as potential publication of results.

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July 14, 2016
Resolution Bioscience to participate at the FDA-AACR Liquid Biopsy Workshop

Resolution Bioscience is pleased to announce its participation in the upcoming FDA-AACR Liquid Biopsies in Oncology Drug and Device Development Workshop on July 19th, 2016.   The purpose of this workshop is to provide a forum for the discussion of relevant scientific advances in the field of liquid biopsies and of the regulatory environment that will support the translation of this emerging technology into improved patient care. The analysis of tumor-derived cell-free DNA (cfDNA) in plasma, a noninvasive method for detecting genetic alterations in tumors, holds considerable promise both for improving cancer diagnoses and monitoring and in drug development.

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June 1, 2016
Resolution Bioscience's ctDx Blood-based NGS Platform used for Plasma Genotyping and Longitudinal Monitoring of ALK Fusion Positive Patients in Clinical Trial

— Resolution Bioscience today announced that its Resolution ctDx™ blood-based NGS platform was used to detect ALK fusions, ALK resistance mutations and other driver mutations in patients' circulating tumor DNA in a phase I/II clinical trial of the ALK inhibitor X-396 (ensartinib), Xcovery's lead drug candidate in development for the treatment of ALK-positive non-small cell lung cancer (NSCLC). The results of this study will be presented at the 2016 ASCO meeting in Chicago and in a publication to follow.

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May 25, 2016
Liquid biopsy testing underway with Seattle lung cancer patients

— Resolution Bioscience of Bellevue, WA announces an ongoing study involving the clinical application of DNA sequencing of circulating tumor DNA in the peripheral blood of lung cancer patients. The study is led by Dr. Keith Eaton, UW Associate Professor of Medicine, and UW Medicine oncologist at the Seattle Cancer Care Alliance.

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May 19, 2016
Genetic Engineering & Biotechnology News profiles Resolution Bio

— Our ctDx platform was covered in GEN's coverage of the liquid biopsy industry.

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October 23, 2015
GenomeWeb cover the publication of Dana-Farber collaboration in CCR

— Coverage of our cell-free DNA platform and publication in Clinical Cancer Research

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May 20, 2015
Resolution Bioscience Receives CLIA Certification for its Diagnostic Laboratory and Launches CLIA-Certified Liquid Biopsy for Lung Cancer.

— Resolution Bioscience announced today the successful results from their CLIA validation of ctDx ALK™, a blood-based liquid biopsy for an ALK-gene fusion driver mutation found in non-small cell lung carcinoma (NSCLC), the most common form of this cancer. Researchers or clinicians can now use the test to guide patients to personalized therapies and direct them into clinical trials with a standard blood sample.

The Department of Health, the CLIA authority in Washington State, surveyed the laboratory and gave its highest assessment of “no deficiencies.”

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April 16, 2015
Resolution Bioscience announces successful collaboration on a novel, non-invasive, targeted NGS test for lung cancer

First clinically actionable, comprehensive liquid biopsy assay that can discover gene fusions that drive lung cancer.

Dana-Farber Cancer Institute and its Belfer Institute for Applied Cancer Science and Resolution Bioscience, Inc. today announced the successful completion of a collaborative agreement to co-develop a novel, blood-based, clinic ready, Next Generation Sequencing (NGS) assay for non-small cell lung cancer (NSCLC). The collaboration is the first to demonstrate the successful sequencing of clinically actionable ALK, RET, and ROS1 fusions in blinded plasma samples and highlights the ability to discover all types of actionable mutations in a single assay from a standard blood draw. The results will be presented at the 2015 American Association for Cancer Research (AACR) meeting on April 19th and in a joint publication to follow.

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