Inivata Ltd. published new data from a prospective clinical study assessing its Radar diagnostic test in head and neck squamous cell carcinoma (HNSCC). Results from the Liquid Biopsy for Minimal Disease Detection in HNSCC (LIONESS) study suggest the assay demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence. The personalized assay can track up to 48 tumor-specific variants in a patient using a blood sample. Last year the test was granted breakthrough device designation by the FDA.
LONDON – Inivata Ltd. is extending efforts to bring its liquid biopsies into routine use, in two new clinical trials in lung cancer. The first will attempt to show increased speed in getting advanced non-small-cell lung cancer (NSCLC) patients on to the most appropriate therapies. The second study aims to demonstrate that detecting circulating tumor DNA (ctDNA) will single out those early-stage lung cancer patients who have residual or recurring disease after surgery and need further treatment with chemo- or immuno-therapies.
LONDON – Neogenomics Inc. reported it plans to acquire Inivata Ltd., taking up a $390 million fixed price option to purchase the liquid biopsy specialist eight months early. The option was agreed to in May 2020, when Neogenomics made a $25 million minority equity investment in Inivata and was granted the right to acquire the rest of the company by the end of 2021.
LONDON – Liquid biopsy specialist Inivata Ltd. has been granted a U.S. FDA breakthrough device designation for its Radar assay for detecting residual disease or relapse, following treatment for cancer. The personalized assay, which tracks a set of up to 48 genetic variants isolated from excised tumor tissue, is built on Inivata’s approved Invision platform for detecting circulating tumor DNA (ctDNA) in blood samples.
LONDON – Neogenomics Laboratories Inc. is to make a $25 million equity investment in Inivata Ltd. and has taken an option to acquire all of the company as part of a U.S. commercialization agreement with the U.K. liquid biopsy specialist. Under the deal, Neogenomics will take over sales, marketing and billing for Inivata’s Invisionfirst circulating tumor DNA lung cancer test, which is intended to replace tissue biopsies.
LONDON – Twenty years on from sequencing of the first draft of the human genome and the associated hype, 2019 was the year that the science of genomics truly began to make an impact in health care.
LONDON – Pfizer Inc. is taking further steps to distinguish its third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena, from the rest of the field, funding a pan-European trial that will use liquid biopsies to track the resistance profile of non-small-cell lung cancers (NSCLC).