COMPANY:

Agilent Tech

"Agilent’s PD-L1 IHC 28-8 pharmDx (Code SK005) provides clinically relevant information about PD-L1 expression – a critical biomarker for potential response to therapies containing anti-PD-1 antibodies such as OPDIVO (nivolumab) which has demonstrated therapeutic value across growing list of cancer types and Opdualag (nivolumab and relatimab)....PD-L1 IHC 28-8 pharmDx (Code SK005) has received European IVDR certification for nine cancer indications, including five companion diagnostic indications; non-small cell lung cancer (NSCLC), muscle invasive urothelial carcinoma (MIUC), melanoma, esophageal squamous cell carcinoma (ESCC), and gastric, gastroesophageal junction (GEJ) and esophageal adenocarcinoma."

"Tagomics Ltd...today announced it has entered into a strategic co-marketing agreement with Agilent Technologies, a leading tools provider in the genomics sector. The agreement offers select customers the opportunity to access Tagomics’ and Agilent Technologies’ combined innovative offerings through an exclusive technology access program hosted out of Tagomics’ service lab in Cambridge."

"Agilent Technologies Inc...announced that it has received FDA approval for the use of MAGE-A4 IHC 1F9 pharmDx (SK032) as a diagnostic tool to aid in identifying patients with synovial sarcoma who may be eligible for treatment with TECELRA (afamitresgene autoleucel, also known as afami-cel or ADP-A2M4), a MAGE-A4-directed engineered TCR T-Cell therapy."

"Agilent Technologies Inc...it has signed a definitive agreement to acquire BIOVECTRA, a leading specialized contract development and manufacturing organization, for $925 million."

"Transcenta Holding Limited...and Agilent Technologies, announce a collaboration to develop a Claudin18.2 (CLDN18.2) companion diagnostic to support TranStar301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma."

"Agilent Technologies Inc...announced today its participation in the American Association for Cancer Research Annual Meeting (AACR). At the meeting, which will take place from April 5 to 10, 2024, in San Diego, CA, Agilent will highlight new cell analysis, genomics, digital pathology, and companion diagnostics solutions."

"Agilent Technologies Inc...today announced an agreement with Incyte that will bring together Agilent’s expertise and proven track record in the development of companion diagnostics (CDx) to support the development and commercialization of Incyte’s hematology and oncology portfolio....The agreement between Agilent and Incyte allows the companies to collaborate on CDx development programs. This will enable Agilent to continue to expand its companion diagnostics portfolio with novel biomarkers and Incyte to leverage Agilent’s expertise in IVD assay development, global regulatory approvals, and commercialization to support clinical trials as well as the potential registration and commercialization of CDx in the United States and Europe."

"Agilent Technologies...announced that it has received FDA approval for the use of PD-L1 IHC 22C3 pharmDx as a diagnostic tool to aid in identifying patients with Gastric or Gastroesophageal Junction (GEJ) Adenocarcinoma who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy....PD-L1 IHC 22C3 pharmDx is the only FDA-approved companion diagnostic that can identify gastric or GEJ adenocarcinoma patients suitable for treatment with KEYTRUDA in combination with chemotherapy and trastuzumab plus fluoropyrimidine. This marks the sixth cancer type for which PD-L1 IHC 22C3 pharmDx has gained FDA approval."

"Roswell Park Cancer Center said this week that Agilent Technologies has licensed its blood cancer assay, PanHeme...Under the licensing agreement, Agilent is now able to commercialize the assay worldwide, supported by its SureSelect XT HS2 library preparation and target enrichment chemistry, Magnis NGS Prep system, Bravo automation platform, and Alissa secondary analysis software."

"Agilent Technologies...recently signed a Research Collaboration Agreement (RCA) with the National Cancer Centre Singapore (NCCS) outlining their collaboration to accelerate translational cancer research on the genomic landscape of Asian-prevalent cancers over the next two years...The scope of the agreement includes the supply of an Agilent Magnis Next-Generation Sequencing (NGS) Preparation System to help investigate details specific to Asian cancer cohorts, where tissue samples derived from routine clinical care remain limited locally and regionally."

"Agilent Technologies...and Exact Sciences Corp...announced they have entered into a definitive agreement for the sale of Resolution Bioscience to Exact Sciences. Financial terms of the agreement were not disclosed and are not material to either party."

"Agilent Technologies...announced the issuing of a companion diagnostic (CDx) Class C IVDR certification for PD-L1 IHC 22C3 pharmDx, Code SK006. This CDx assay has previously been CE-IVD–marked for sales in the European Union and is now certified in accordance with the new EU Regulation for in vitro diagnostic medical devices (IVDR)."

"Agilent Technologies...announced the recent signing of a Memorandum of Understanding (MOU) with Theragen Bio in South Korea to boost precision oncology through advancing bioinformatic (BI) solutions. As part of the partnership agreement, Agilent and Theragen Bio will combine their respective strengths in cancer genomic profiling (CGP) design, engineering knowledge and software expertise to drive localized analysis capabilities and accelerate treatment decisions...Agilent’s SureSelect Cancer CGP assay uses next generation sequencing (NGS) to transform translational research and clinical trials in oncology through high throughput sequencing of DNA and RNA bases in parallel, while reducing hands-on time to maximize lab efficiency."

"NGeneBio said it agreed with Agilent Technologies Korea...to cooperate in the Korean and international next-generation sequencing (NGS) precision diagnostics market...Under the latest agreement, NGeneBio's solid cancer precision diagnostic product, ONCOaccuPanel will be applied to Agilent's Magnis NGS Prep System. Then, Agilent can sell it as a package."

"Agilent Technologies...announced the launch of the Agilent SureSelect Cancer CGP Assay designed for somatic variant profiling for a broad range of solid tumor types. The pan-cancer assay design is based on an NGS panel comprising 679 genes globally curated from leading cancer databases and in partnership with key clinical cancer researchers. The assay workflow is efficient, automatable, and flexible, making tumor molecular profiling more accessible to the broad clinical research community."

"Agilent Technologies Inc...announced today that it will highlight new cell analysis, genomics, digital pathology, and companion diagnostics solutions at the American Association for Cancer Research Annual Meeting, held April 14-19, 2023, in Orlando, Florida....A highlight at AACR will be the full commercial launch of the new Agilent SureSelect Cancer Comprehensive Genomic Profiling (CGP) Assay, an NGS-based pan-cancer panel for somatic variant detection from solid tumors."

"Agilent Technologies Inc...announced a strategic partnership with PathAI, a leading provider of AI-powered research tools and services for pathology, to deliver biopharmaceutical organizations a solution that combines Agilent’s assay development expertise and PathAI’s algorithm development capabilities. By incorporating AI into CDx development, the partnership enables Agilent and PathAI to build integrated solutions with assays and machine learning analysis algorithms....In line with that vision, Agilent also announces a multiyear global distribution agreement with PathAI to distribute both versions of their platform AISight and AISight DX+ along with AIM-PD-L1 NSCLC, an algorithm for PD-L1 quantification in non-small cell lung cancer (NSCLC), to anatomic pathology laboratories. Further, through this partnership, Agilent may also commercialize additional algorithms PathAI launches in the future."

"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."