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The good news keeps on coming! Last week, we announced our FDA Breakthrough Designation for our at-home self-collect cervical cancer screening device and yesterday, Roche and BD announced they have received FDA approval for their in-clinic self-collect cervical cancer screening methods. Our Breakthrough Designation grants us priority review with the FDA once we submit our final study data, and the in-clinic approval is an important first step in helping to bring at-home screening through the FDA. Our clinical trial was run on both the Roche and BD Primary HPV assays. We are thrilled for Roche and BD and congratulate them on this important work to expand screening options for women and people with a cervix. #womenshealth #tealhealth #femtech https://lnkd.in/ep7CVdKG

FDA approves self-collection screening for virus that causes cervical cancer

FDA approves self-collection screening for virus that causes cervical cancer

washingtonpost.com

Hope Meely

VP Clinical Operations / Biospecimen Lifecycle Focused / Oncology & Immunology

4mo

Congratulations such a great step forward in Women’s Health!

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