Lung Health and Human Rights Expert Dr. Carolyn Dresler Joins ASH Board of Trustees
Action on Smoking and Health (ASH), the oldest anti-tobacco organization in the US, announced the appointment of Carolyn Dresler, MD, MPA, to its Board of Trustees. Dr. Dresler, who retired in 2018 as the Associate Director for Medical and Health Sciences for the Office of Science at the Center for Tobacco Products at the US Food and Drug Administration (FDA), brings decades of clinical lung health and policy expertise to ASH.
She was recently awarded the American Lung Association’s 2022 C. Everett Koop Unsung Hero Award “for her remarkable career and contributions she made to significantly reducing tobacco use in Colorado, the US, and around the world,” according to a statement from the American Lung Association.
Before working at the FDA, Dr. Dresler was director of the Arkansas Department of Health’s Tobacco Prevention and Cessation Program. She was also the head of the Tobacco and Cancer Unit at the International Agency for Research on Cancer in Lyon, France.
In 2009, Dr. Dresler became the founder and board chair of the Human Rights and Tobacco Control Network (HRTCN), a global non-governmental organization dedicated to using human rights to end the tobacco epidemic. The network is now housed under ASH as a network of experts supporting the connection of human rights and tobacco control.
Novel Liquid Biopsy Assay for Lung Carcinoma Detection Receives FDA Breakthrough Device Designation
The biotech company Micronoma recently announced that its OncobiotaLUNG assay, the first blood microbiome-driven liquid biopsy with proven effectiveness, including identifying cancer in its earliest stages, has received Breakthrough Device Designation from the FDA.
As a result of the FDA designation, Micronoma can expect continued guidance and prioritized reviews from the agency of its upcoming clinical trial and concomitant pre-market approval processes. The FDA based its Breakthrough Device decision on the ability of Micronoma’s technology to categorize lung nodules into high risk or low risk of malignancy through a simple blood draw, even in the earliest stages of the disease, compared to the current standard of care.
The work that led to the Breakthrough Device Designation is based on the findings of Micronoma’s co-founders, published in the scientific journals Nature1 and Cell2. These discoveries were then validated in a large, lung-specific cohort, as described in a manuscript shared with the FDA and currently under review at a high-impact journal.
References
- 1. Poore, G.D., Kopylova, E., Zhu, Q. et al. Microbiome analyses of blood and tissues suggest cancer diagnostic approach. Nature 579, 567–574, March 11, 2020.
- 2. Narunsky-Haziza et al., Pan-cancer analyses reveal cancer-type-specific fungal ecologies and bacteriome interactions, Cell 185, 3789–3806, September 29, 2022