COMPANY:

Agilent Tech

"SOPHiA GENETICS...is partnering with Agilent to offer a comprehensive solution for cancer analysis...Through the partnership, the SOPHiA DDM Platform will be integrated with Agilent’s new Research Use Only SureSelect Cancer Comprehensive Genomic Profiling (CGP) Assay Kit. This will enable clinical researchers to accurately identify multiple biomarkers, lowering the risk of missing important information in cancer samples. The partnership brings together these two companies’ strengths in analytics and next generation sequencing (NGS) assay development to facilitate novel approaches to cancer research."

"Agilent Technologies Inc....announced an agreement with Quest Diagnostics (NYSE: DGX), the world’s leading provider of diagnostic information services. The alliance will enable providers and patients throughout the United States to access the Agilent Resolution ctDx FIRST liquid biopsy next-generation sequencing (NGS) test....The agreement between Quest and Agilent will enable broad adoption for ctDx FIRST, a single-site premarket approved (ssPMA) test performed at the Resolution Bioscience CLIA laboratory in Kirkland, Washington....Under the terms of the agreement, Quest will offer ctDx FIRST to healthcare providers in the United States seeking a minimally invasive liquid biopsy test option as a CDx for KRAZATI."

"Agilent Technologies...announced a partnership with Akoya Biosciences...to develop multiplex-immunohistochemistry diagnostic solutions for tissue analysis and to commercialize workflow solutions for multiplex assays in the clinical research market...Agilent and Akoya will partner to develop chromogenic and immunofluorescent multiplex assays that include spatial analysis for biopharma companies developing precision cancer therapeutics."

"Agilent Technologies...announced the acquisition of Avida Biomed...The acquisition complements Agilent’s market-leading SureSelect portfolio and further augments Agilent’s strategy to expand into the high-growth clinical research and diagnostics markets. The chemistries and assays from Avida Biomed are compatible with Agilent’s automation platforms including Magnis and Bravo, which will facilitate efficient scaling of research experiments and routine sample testing."

"Agilent Technologies...announced today that the U.S. Food and Drug Administration (FDA) has approved Agilent Resolution ctDx FIRST as a companion diagnostic (CDx) to identify advanced non-small cell lung cancer (NSCLC) patients with KRAS G12C mutations who may benefit from treatment with KRAZATI^TM (adagrasib). This is the first liquid biopsy NGS assay approved by the FDA as a CDx for the newly approved KRAZATI in advanced NSCLC and was developed in collaboration with Mirati Therapeutics."

"Agilent Technologies Inc...announced that the South Korea Ministry of Food and Drug Safety (MFDS) has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer (NSCLC) who are suitable for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform."

"Agilent Technologies...announced that its PD-L1 IHC 22C3 pharmDx, Code SK006, is now EU CE-IVD–marked for use in cervical cancer. PD-L1 IHC 22C3 pharmDx can be used as an aid in identifying cervical cancer patients for whom treatment with KEYTRUDA® (pembrolizumab) may be appropriate."

"Agilent Technologies Inc...announced CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx immunohistochemical assay to extend the use of the test to patients diagnosed with muscle-invasive urothelial carcinoma (MIUC) who have tumor cell PD-L1 expression ≥ 1% for adjuvant treatment with OPDIVO® (nivolumab), a PD-1-targeted immunotherapeutic from Bristol Myers Squibb."

"Agilent Technologies Inc...announced it has expanded CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx as an aid in identifying esophageal squamous cell carcinoma patients for treatment with Bristol Myers Squibb’s PD-1-targeted immunotherapeutic OPDIVO® (nivolumab), in combination with fluoropyrimidine and platinum-based chemotherapy or OPDIVO® in combination with YERVOY® (ipilimumab). These combined treatments provide new hope for patients diagnosed with these cancers."

"Agilent Technologies Inc...announced that its PD-L1 IHC 22C3 pharmDx assay is now labelled for use in TNBC in the European Union...The expanded use of PD-L1 IHC 22C3 pharmDx strengthens the ability of pathologists to identify patients who may be eligible for treatment with KEYTRUDA. In Europe, KEYTRUDA, in combination with chemotherapy, is indicated for the treatment of locally recurrent unresectable or metastatic TNBC in adults whose tumors express PD-L1 [Combined Positive Score (CPS) ≥ 10] and who have not received prior chemotherapy for metastatic disease."

"Agilent Technologies Inc...announced it has received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers....When used in conjunction with the PD-L1 IHC 28-8 pharmDx as a companion test, treatment with Opdivo® in combination with chemotherapy provides the first and only PD-1-directed treatment to demonstrate superior overall survival (OS) and progression-free survival (PFS) when compared to chemotherapy alone in patients with advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5."

"Agilent Technologies...announced its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) is now FDA approved as an aid in identifying patients with early breast cancer (EBC) at high risk of disease recurrence, for whom adjuvant treatment with Verzenio® (abemaciclib) in combination with endocrine therapy is being considered. This is the first IHC assay measuring Ki-67 expression to receive FDA approval in the context of treatment with Verzenio and was developed in collaboration with Eli Lilly and Company."

"Agilent Technologies In...today announced that the company’s PD-L1 IHC 22C3 pharmDx assay has expanded its use in Europe. The assay is now CE-IVD marked for use as an aid in identifying esophageal cancer patients for treatment with KEYTRUDA using Combined Positive Score (CPS) ≥ 10."

"Agilent Technologies Inc...announced the publication of a paper in the journal Lung Cancer, titled 'Clinical Utility of Next-Generation Sequencing-Based ctDNA Testing for Common and Novel ALK Fusions'. The study, jointly published by Resolution Bioscience (now a part of Agilent) and Memorial Sloan Kettering Cancer Center (MSK), describes the use of plasma ctDNA NGS to detect novel anaplastic lymphoma kinase (ALK) fusions, and to serially monitor the development of mechanisms of resistance in response to targeted therapy."

"Agilent Technologies Inc...today announced that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union. PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo® (cemiplimab). This announcement underscores Agilent's continuing commitment to the development of IHC-based diagnostics for cancer therapy."

"Agilent Technologies Inc. (NYSE: A) today announced a presentation by Memorial Sloan Kettering Cancer Center (MSK) at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) to discuss the Resolution ctDx Lung, a laboratory-developed test (LDT) developed by Resolution Bioscience. The presentation titled Overall survival with circulating tumor DNA-guided therapy in advanced non-small cell lung cancer will present evidence for the clinical utility of Resolution ctDx Lung in detecting actionable mutations in non-small cell lung cancer (NSCLC) patients."

"Agilent Technologies, Inc...today announced it has completed the acquisition of Resolution Bioscience...The addition of Resolution Bioscience’s liquid biopsy-based diagnostic technologies strengthens Agilent’s offerings to biopharma and clinical diagnostics customers and boosts growth opportunities in the company’s diagnostics and genomics business."

"Agilent Technologies Inc...today announced it has entered into a definitive agreement to acquire Resolution Bioscience Inc., a leader in the development and commercialization of next-generation sequencing (NGS)-based precision oncology solutions. The acquisition complements and expands Agilent’s capabilities in NGS-based cancer diagnostics and provides the company with innovative technology to further serve the needs of the fast-growing precision medicine market. Under the terms of the agreement, Agilent will pay $550 million in cash at closing and up to an additional $145 million based on achieving future performance milestones."

"Agilent Technologies...announced that the U.S. Food and Drug Administration (FDA) has approved the company’s PD-L1 IHC 22C3 pharmDx assay for expanded use in patients with non-small cell lung cancer (NSCLC). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo® (cemiplimab-rwlc)."

"Resolution Bioscience, Inc...announced a companion diagnostic agreement with Mirati Therapeutics, Inc...As part of the agreement, Resolution’s ctDx™ liquid biopsy technology will be used to help identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy....Mirati’s investigational drug candidate adagrasib (MRTX849) is an orally available small molecule that potently and selectively inhibits the G12C substitution mutation. The Resolution assay will be used to identify patients whose cancers are driven by this KRAS variant."

"Agilent Technologies Inc...today announced its clinical informatics platform Alissa Interpret has been adopted by the North West Genomic Laboratory Hub (NW GLH) based in Manchester and Liverpool, part of Manchester University NHS Foundation Trust, England. The NW GLH and its partners are responsible for delivering genomic testing across the whole of the North West. Alissa Interpret, which enables clinical genetics labs to standardize and automate variant triage, review, classification, and reports on NGS data, becomes one of two platforms the NW GLH will use to analyze genomics data."

"Agilent Technologies Inc…has announced the signing of a memorandum of understanding (MOU) with GI Innovation (GII), a Korean clinical-stage biopharmaceutical company…The aim is to conduct genomic profiling using tumor tissue samples in GI-101-P101...This partnership with GI Innovation will help establish Agilent as a trusted clinical partner in Korea and promote NGS-based comprehensive biomarker profiling early on in clinical trials...The Agilent NGS panel tumor profiling assay that will be used enables genomic profiling of more than 500 cancer-related genes in a single assay with measurement of tumor mutational burden (TMB) including microsatellite instability-high (MSI-H), as well as variants characterization in tumor suppressor genes and genes involved in homologous recombinant repair (HRR), important emerging biomarkers in immuno-oncology."

"Agilent Technologies Inc…announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer (NSCLC). Now, physicians will be able to use the PD-L1 IHC 28-8 pharmDx assay as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb."

“Agilent Technologies Inc…announced that the U.S. Food and Drug Administration has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer who are appropriate for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.”