COMPANY:

Strata Oncology

"Strata Oncology...announced the publication of a new peer-reviewed study validating the clinical utility of the company's proprietary pan-solid tumor predictive biomarker for anti-PD-1/PD-L1 checkpoint inhibitor monotherapy benefit, Immunotherapy Response Score (IRS). The study was published by Communications Medicine, a Nature publication....Key findings from the study include: IRS predicted real-world progression-free survival and overall survival in anti-PD-1/PD-L1 monotherapy treated patients across tumor types....In non-small cell lung cancer (NSCLC) patients who were IRS-high, there was no significant benefit of combination therapy (pembrolizumab + chemotherapy) compared to monotherapy (pembrolizumab)."

"Strata Oncology, Inc...announced the integration of discrete genomic data from its StrataNGS® next-generation sequencing-based tumor profiling with the University of Wisconsin Carbone Cancer Center and UW Health Epic genomics module....The integration will streamline workflows for physicians by creating an easily-accessible and user-friendly database, allowing them to more quickly identify the optimal therapy for each patient with cancer. This integration will also enable the institution to expand its research and understanding of cancer."

"Strata Oncology, Inc...announced that Lehigh Valley Topper Cancer Institute and the University of Michigan Health Rogel Cancer Center have joined as clinical trial sites in the Strata SentinelTM trial, a prospective, observational study of the StrataMRD^TM minimal residual disease test that has the potential to shift the paradigm of cancer care, bringing the use of biomarker-matched precision therapies to earlier stages of the disease."

"Strata Oncology, Inc...announced that...will participate in two panel discussions at the Precision Medicine World Conference (PMWC) 2022, being held live from June 28-30 in Santa Clara, CA...Title: Dismantling Barriers to Biomarker Testing Through Collaboration"

"Strata Oncology, Inc...announced enrollment of the first patient in the Strata Sentinel trial, a prospective, observational study that will evaluate the ability of the investigational StrataMRD test to detect cancer recurrence in advance of standard of care techniques across solid tumors, as well as the clinical benefit of treatment in early-stage patients who are or become ctDNA-positive after surgery or other therapy with curative intent....'We are pleased to be a part of the Strata Sentinel trial. Bringing the latest innovations in precision oncology to our patients is critical to our vision of changing and saving lives,' said Marc Matrana, MD...the site at which the first Sentinel patient has been enrolled. 'We look forward to working with Strata Oncology to change the paradigm of care for patients with early-stage cancer.'"

"Strata Oncology, Inc...announced enrollment of the first patient in the Strata Sentinel trial, a prospective, observational study that will evaluate the ability of the investigational StrataMRD test to detect cancer recurrence in advance of standard of care techniques across solid tumors, as well as the clinical benefit of treatment in early-stage patients who are or become ctDNA-positive after surgery or other therapy with curative intent."

"Strata Oncology, Inc...announced results from validation studies demonstrating the reliable performance of the StrataNGS test were published in The Journal of Molecular Diagnostics. StrataNGS is a 429-gene, multiplex PCR-based comprehensive genomic profiling (CGP) test performed on co-isolated DNA and RNA from formalin-fixed paraffin-embedded (FFPE) tissue tumor specimens with >2mm2 tumor surface area...Through a unique assay configuration and novel bioinformatics pipeline optimized for multiplex PCR-based sequencing, StrataNGS demonstrated high sensitivity and specificity for detecting single nucleotide variants, insertions/deletions, gene fusions, copy number alterations, microsatellite instability and tumor mutation burden."

"Strata Oncology, Inc...announced the publication of a new peer-reviewed study in which more than double the number of tumor tissue samples met minimum tumor surface area (TSA) for StrataNGS- a PCR-based comprehensive genomic profiling (CGP) test that features the lowest tumor tissue requirements of any CGP test – versus other leading commercial hybrid capture-based CGP tests."

"Strata Oncology, Inc...announced the completion of a $90 million Series C financing, bringing the company's total financing to over $130 million since the company's inception. The proceeds will be used to accelerate the development of Strata Oncology's personalized minimal residual disease (MRD) assay for early-stage cancers and advance its pipeline of novel RNA-based treatment selection tests for solid tumors."

"The Access to Comprehensive Genomic Profiling Coalition (ACGP) announced today the addition of Strata Oncology, a precision oncology company advancing molecular indications for cancer therapies. ACGP is comprised of diagnostics companies, laboratory service providers, and CGP industry stakeholders to advocate for appropriate broad U.S. health insurance coverage of comprehensive genomic profiling (CGP) for patients living with advanced cancer."

"Strata Oncology, Inc...today announced the launch of the Strata Assistant app for Epic with Kettering Health Network as its first fully integrated user. Available now in the Epic App Orchard, Strata Assistant is integrated within the Epic electronic medical record (EMR) management system to streamline StrataNGS test submission by pre-populating the test requisition form with existing data from EMR management systems, ensuring data accuracy while reducing data entry burden on care teams."

"Strata Oncology, Inc...today announced the Strata Precision Indications for Approved Therapies, or 'Strata PATH,' trial. Strata PATH is a multi-drug, multi-arm, biomarker-driven clinical trial designed to evaluate the efficacy of FDA-approved targeted- and immunotherapies in new Strata-defined biomarker indications. Pfizer Inc. (NYSE: PFE) will provide marketed, targeted drugs for four study arms at no cost to participants...The trial will use Strata-defined biomarker profiles from comprehensive DNA and RNA profiling to match patients to one of several different investigational treatment arms...Strata PATH will enroll patients with advanced solid tumors who have exhausted standard lines of therapy, are positive for specific biomarker profiles assessed by the StrataNGS test and have not previously been treated with the identified class of therapy."

"Strata Oncology, Inc…today announced plans to begin enrolling the Sentinel Trial in the first half of 2021. Sentinel is a prospective, observational study designed to enroll approximately 100,000 patients diagnosed with stage 1-3 solid tumors and indicated for surgery or definitive therapy. The study will evaluate the ability of Strata's investigational liquid biopsy assay to detect disease recurrence and to monitor treatment effectiveness in patients across solid tumors."

"Strata Oncology, Inc…today announced it had completed a significant renovation and expansion of its high-throughput cancer sequencing facility, resulting in a doubling of its previous laboratory capacity. The lab expansion incorporates technology and operational throughput to deliver StrataNGS, a comprehensive genomic profiling test with industry-low tumor tissue requirements, to more physicians and their patients. Strata also increased its research and development capacity to continue to expand its portfolio of proprietary molecular profiling tests."

"Strata Oncology, Inc…announced that Palmetto GBA, a Medicare Administrative Contractor (MAC), has established coverage of the StrataNGSTM test for patients with advanced stages (III or IV), recurrent, relapsed, refractory, and/ or metastatic solid tumors."