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Micronoma Breaks Through With Microbiome-BIOTECH: FDA Designation a ‘Milestone’

Micronoma Breaks Through With Microbiome-BIOTECH: FDA Designation a ‘Milestone’

Feb 8, 2023

Micronoma’s microbiome platform is breaking into its next phase with validation from the U.S. Food and Drug Administration. Last month, the San Diego-based company announced that the FDA has given its OncobiotaLUNG assay Breakthrough Device Designation. The...
FDA Grants Novel Liquid Biopsy Assay Breakthrough Device Designation to Detect Lung Cancer

FDA Grants Novel Liquid Biopsy Assay Breakthrough Device Designation to Detect Lung Cancer

Jan 30, 2023

The FDA has granted breakthrough device designation to the novel, microbiome-driven, liquid biopsy assay OncobiotaLUNG for the detection of lung carcinomas, according to a press release from developer Micronoma.1 The assay is one of the first blood microbiome­–driven...
In Brief This Week: Micronoma, Legend Biotech, Point Biopharma, AstraZeneca, Daiichi Sankyo, Takeda,

In Brief This Week: Micronoma, Legend Biotech, Point Biopharma, AstraZeneca, Daiichi Sankyo, Takeda,

Jan 30, 2023

  Read more at Precision Oncology News...
FDA Grants Breakthrough Device Designation to OncobiotaLUNG Assay for Lung Cancer Detection

FDA Grants Breakthrough Device Designation to OncobiotaLUNG Assay for Lung Cancer Detection

Jan 30, 2023

The FDA has granted the OncobiotaLUNG assay a breakthrough device designation for the early detection of lung cancer. The FDA has provided the OncobiotaLUNG assay a breakthrough device designation, according to the device maker, Micronoma.1 The OncobiotaLUNG assay is...
Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection

Micronoma Receives FDA Breakthrough Device Designation for OncobiotaLUNG, A Novel Liquid Biopsy Assay for Lung Carcinoma Detection

Jan 30, 2023

Micronoma, the first biotech company offering early cancer detection with a microbiome-driven liquid biopsy platform, announced today that its OncobiotaLUNG assay received the Breakthrough Device Designation from the Food and Drug Administration (FDA). As a...
Highs And Lows In The Under 30 World: From A Cancer Screening Breakthrough To A JP Morgan Lawsuit

Highs And Lows In The Under 30 World: From A Cancer Screening Breakthrough To A JP Morgan Lawsuit

Jan 30, 2023

We’ll start with the acquisition: This week, daily e-newsletter Morning Brew announced that it had acquired One Future, a digital media startup, with the hopes of tapping a larger Gen Z audience. The companies declined to disclose terms of the deal. Our Future...
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