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The accelerated approval is based on data showing that refractory cancer patients with TMB of at least 10 mutations/Mb saw tumor shrinkage and had durable responses on the immunotherapy.
Dante Labs will use library preparation kits from Nonacus and software from CCG.ai to create a sample-to-report service, the firms said.
The firm expects to launch a tissue-based immunohistochemistry version of the test, which detects QSOX1, in mid-2021, followed by a dipstick plasma-based assay by early 2022.
Lexent Bio's monitoring platform is in development and based on low-pass whole-genome sequencing and DNA methylation analysis.
The company is commercializing a genome-wide sequencing method called MRDetect, developed by researchers at the New York Genome Center and Weill Cornell Medicine.
The Tucson, Arizona-based firm signed agreements with Denmark-based BioNordika, Czech Republic-based Explorea, and Bulgaria-based Elta 90.
At the American Society of Clinical Oncology's virtual meeting, investigators presented two new studies of BluePrint classification patterns.
The firm touts a new hybridization probe design, which it says will enable small, focused panels that reduce sequencing costs and assay time.
Genetron's S5 sequencer is based on Thermo Fisher's Ion GeneStudio S5 instrument and is cleared for clinical use by China's NMPA.
The framework is meant to guide healthcare providers in facilitating prostate cancer genetic testing in a timely and responsible way, the researchers said.
NeoGenomics will offer the Thyroid Profile and the NGS Thyroid Profile plus RET FISH test as part of the program, which is sponsored by Lilly.
Thermo will develop a test using its Oncomine Precision Assay to identify IDH1- and IDH2-positive low-grade glioma patients for treatment with Agios' vorasidenib.
The decision comes after Myriad requested expanded coverage for women with breast cancer seeking information about extending endocrine therapy.
The New York-based firm will use the funding to develop and clinically validate its personalized, real-time tool for monitoring recurrence and treatment response for various sold cancer types.
Promega will seek to expand use of the assay in Europe while it works through regulatory review of the test for companion diagnostic use in the US and Asia.
ArcherDx has leveraged next-generation sequencing to develop and commercialize more than 325 research-use-only products and a pan-solid tumor diagnostic test.
The Swedish company said it will use the funds in part to accelerate the commercialization of its PanCan-d test for early-stage pancreatic cancer detection.
Sienna said that Unilabs, a commercial lab in Sweden, is evaluating its hTERT bladder cancer test for routine use.
New data shows that the test could eventually be useful in helping younger women avoid chemotherapy in the neoadjuvant setting.
The DXRX marketplace, planned for launch in the fourth quarter of 2020, will provide a way for pharmaceutical companies, diagnostic firms, and laboratories to collaborate.