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US Food and Drug Administration Releases Templates for Monkeypox Antigen Test Development
2022-12-01
The US Food and Drug Administration on Tuesday expanded its library of guidance for monkeypox test developers by releasing two templates for development of antigen tests for monkeypox infection, following the publication earlier this year of a pair of templates for molecular test development.
Monkeypox to be renamed by WHO; ‘mpox’ will phase in over next year
2022-12-01
Amid what it called an online barrage of “racist and stigmatizing language” about monkeypox, the World Health Organization said on Monday it will begin using a new preferred term “mpox” as a synonym for the disease.
CAIRE® to Acquire MGC Diagnostics Holdings, Inc.
2022-11-30
CAIRE Inc., a subsidiary of NGK SPARK PLUG CO., LTD., will acquire St. Paul, Minnesota-based MGC Diagnostics Holdings, Inc. (MGC).
New drug for prevention! Chinese biologic anti-neocon monoclonal antibody F61 nasal spray approved for clinical use, effective in reducing the positive switch rate in the close contact population
2022-11-29
On November 28th China Biologics public release said that the company's anti-neoconazole monoclonal antibody F61 nasal spray developed by the company was approved for clinical use.
SeekIn Receives CE-IVD Mark for Cancer Recurrence Monitoring Test
2022-11-29
Liquid biopsy firm SeekIn said Monday that it has received a CE mark for its cancer recurrence monitoring test, SeekInCure, and is preparing to launch assay kits in the European Union and other countries that recognize the designation.
Biomarker Predicts Resistance to Immunotherapies in Melanoma
2022-11-29
Duke Cancer Institute researchers have identified potential biomarkers that predict the likelihood for checkpoint inhibitor drugs to backfire, driving hyper-progression of melanoma cells instead of unleashing the immune system to fight them.
Two units obtained the first AI Class III medical device registration certificate in China's in vitro diagnostic industry!
2022-11-28
According to the WeChat public account of Peking Union Medical College Hospital on November 21, the peripheral blood cell image leukocyte assisted recognition software jointly developed by the Laboratory Department of Peking Union Medical College Hospital and Beijing Xiaofly Technology passed
Cue Health Q3 Revenues Decline 69 Percent
2022-11-28
Cue Health on Wednesday afternoon announced that revenues for the third quarter beat both Wall Street expectations and previous guidance from the firm.
MGI Sequencing Platform and Sentieon Machine Learning Model Enable Improved Small Variant Calling Accuracy for Whole-Genome Sequencing Data
2022-11-28
DNAscope, a germline variant-calling pipeline from San Jose-based analytics firm Sentieon, achieved superior SNP and indel accuracy as compared to other standard datasets, according to a recent preprint from the company.
CMEF 2022 suddenly shut down due to the epidemic situation
2022-11-25
The 86th China International Medical Equipment Fair (CMEF) was suspended in consideration of the health and safety of all participants.
Medtronic lowers full-year forecast, citing drop in procedure growth
2022-11-25
A slower-than-expected recovery in certain procedures, including TAVR and spinal cord stimulation, curbed quarterly profit and revenue.
Avacta to Acquire Dx Distributor Launch Diagnostics for up to £37M
2022-11-25
Avacta, a UK-based developer of cancer immunotherapies and diagnostics, said on Tuesday that it has signed an agreement to acquire Launch Diagnostics for up to £37 million ($41.9 million).
Biocare Medical Acquires Empire Genomics
2022-11-24
Lab testing supply firm Biocare Medical said Tuesday that it has acquired Empire Genomics, a provider of molecular probes for cancer research and diagnostics development, for an undisclosed amount.
FDA Grants Emergency Use Authorization for Premier Medical At-Home COVID Assay
2022-11-24
The US Food and Drug Administration last week granted Emergency Use Authorization for Premier Medical Laboratory Services' Diversified Medical Healthcare SARS-CoV-2 Assay.
Assure Tech COVID-19 Antigen Home Test Gets FDA Emergency Use Authorization
2022-11-23
The COVID-19 Antigen Home Test manufactured by Assure Tech has been validated by laboratory and clinical studies to meet FDA standards and has been granted EUA. This means that the product can be marketed in the USA and in countries that recognise FDA EUA approval.
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