- Lung Tumor Model Improves Understanding of Cancer-Drug Resistance
- Comparative Toxicity of 34 FDA-Approved Cancer Drugs
- Targeted Therapy for Triple-Negative Breast Cancer (TNBC)
- NCTR’s Role in the American Association of Cancer Research (AACR) Annual Meeting
Latest Science News from NCTR
NCTR Scientists to Present at HESI Gut Microbiome Workshop This June 25-26, 2018 in Alexandria, Virginia, scientists from NCTR will participate in the Health and Environmental Sciences Institute’s (HESI) Gut Microbiome Workshop — Dr. Donna Mendrick is co-chair and will be the introductory speaker, Dr. Carl Cerniglia is an invited speaker, and Drs. Steve Foley and Sangeeta Khare will serve as discussion leaders. The HESI website states “This workshop will review the science and initiate discussions on multiple topics, including a) identification of biomarkers of toxicity for alterations in gut microbial function, b) if changes in the microbiome can affect efficacy of medicines, and c) if exposure to xenobiotics can eventually result in a disease state through changes in the microbiome. Conclusions from this workshop will help determine the location of data gaps so researchers can start answering these questions.”
FDA and Other Federal Agencies Release Strategic Plan for Microbiome Research
Carl Cerniglia, Ph.D., Director of NCTR’s Division of Microbiology, represented FDA on the Microbiome Interagency Working Group comprised of 23 U.S. government agencies. This working group was charged with developing a five-year Interagency Strategic Plan for Microbiome Research
. The strategic plan outlines the objectives, structure, and principles for coordinated research in the important field of microbiome research. The plan’s executive summary states, “Microbiome science aims to advance understanding of microbial communities (microbiomes) for applications in areas such as health care, food production, and environmental restoration to benefit individuals, communities, and the planet.”
Carl Cerniglia, Ph.D., Director of NCTR’s Division of Microbiology, represented FDA on the Microbiome Interagency Working Group comprised of 23 U.S. government agencies. This working group was charged with developing a five-year Interagency Strategic Plan for Microbiome Research
. The strategic plan outlines the objectives, structure, and principles for coordinated research in the important field of microbiome research. The plan’s executive summary states, “Microbiome science aims to advance understanding of microbial communities (microbiomes) for applications in areas such as health care, food production, and environmental restoration to benefit individuals, communities, and the planet.”
You can find more information on the National Science Foundation web site.
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Genome-Wide Mutation Detection
Scientists from NCTR demonstrated that genome sequencing — using InterClonal Genetic Variation (ICGV) — can directly measure gene mutations. One of the advantages of ICGV is that it can identify mutations genome-wide by comparing next-generation sequencing data from single-cell clones from the same organism. To provide a proof-of-principle for this assay, E. coli and rats were exposed to standard mutagens. In the bacterial studies, dose- and treatment time-dependent increases in mutation frequency were detected using ICGV. In fact, using ICGV, scientists could identify a ∼20-fold increase in mutations in the T-cell clones cultured from mutagen-treated rats.
Scientists from NCTR demonstrated that genome sequencing — using InterClonal Genetic Variation (ICGV) — can directly measure gene mutations. One of the advantages of ICGV is that it can identify mutations genome-wide by comparing next-generation sequencing data from single-cell clones from the same organism. To provide a proof-of-principle for this assay, E. coli and rats were exposed to standard mutagens. In the bacterial studies, dose- and treatment time-dependent increases in mutation frequency were detected using ICGV. In fact, using ICGV, scientists could identify a ∼20-fold increase in mutations in the T-cell clones cultured from mutagen-treated rats.
Conventional mutation assays estimate the frequency of mutations by screening for the activation or inactivation of reporter genes. These reporter genes enable scientists to measure mutation frequency, but these assays can only detect mutations in narrow areas of the genome and their use is often restricted to certain models. ICGV demonstrates that genetic differences of single-cell clones can be used for genome-wide mutation detection in a variety of species and without the need for reporter genes. This work by scientists at NCTR was recently awarded the FDA Commissioner’s Special Citation. An article describing these findings is now available in Mutation Research/Genetic Toxicology and Environmental Mutagenesis.
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For more information, please contact Javier R. Revollo, Ph.D., Division of Genetic and Molecular Toxicology, FDA/NCTR.
Microbial Contamination Found in Tattoo and Permanent Makeup (PMU) Inks
Scientists from FDA’s NCTR and Center for Food Safety and Nutrition surveyed unopened, sealed bottles of tattoo and PMU inks sold in the United States for microbial contamination and found evidence that contamination of tattoo and PMU inks is more common than previously thought. The results of this study highlight the importance of monitoring these products for potentially pathogenic microorganisms. Among the 85 tattoo and PMU inks purchased from 13 companies, 42 inks (49%) were contaminated mostly with bacteria, but fungi were also detected. However, levels of microbiological contamination varied, and 83 bacterial strains belonging to 20 genera and 49 species were identified, including possibly clinically relevant pathogenic strains — Pseudomonas aeruginosa, Dermacoccus barathri, and Roseomonas mucosa. Tattoo and PMU ink-related microbial infections have recently increased and are now considered to be an emerging safety concern for public health. A manuscript describing the study is available in the Journal of Applied Microbiology.
Microbial Contamination Found in Tattoo and Permanent Makeup (PMU) Inks
Scientists from FDA’s NCTR and Center for Food Safety and Nutrition surveyed unopened, sealed bottles of tattoo and PMU inks sold in the United States for microbial contamination and found evidence that contamination of tattoo and PMU inks is more common than previously thought. The results of this study highlight the importance of monitoring these products for potentially pathogenic microorganisms. Among the 85 tattoo and PMU inks purchased from 13 companies, 42 inks (49%) were contaminated mostly with bacteria, but fungi were also detected. However, levels of microbiological contamination varied, and 83 bacterial strains belonging to 20 genera and 49 species were identified, including possibly clinically relevant pathogenic strains — Pseudomonas aeruginosa, Dermacoccus barathri, and Roseomonas mucosa. Tattoo and PMU ink-related microbial infections have recently increased and are now considered to be an emerging safety concern for public health. A manuscript describing the study is available in the Journal of Applied Microbiology
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For more information, please contact Carl Cerniglia, Ph.D., Director, Division of Microbiology, FDA/NCTR or Seong-Jae Kim, Ph.D., Division of Microbiology, FDA/NCTR.
First Report on the CLARITY-BPA Core Study
A “Draft NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats” was publicly released by the National Toxicology Program (NTP) in February 2018 and was reviewed by a panel of experts in April 2018. The NCTR-conducted two-year rat study was part of an NTP-led effort known as CLARITY-BPA — short for Consortium Linking Academic and Regulatory Insights on BPA Toxicity. As stated in NTP’s Update Newsletter, “NIEHS (National Institute of Environmental Health Sciences) and FDA convened CLARITY-BPA to study the full range of potential health effects from exposure to BPA in rats and to provide data that could be used for regulatory decisions. CLARITY-BPA united standard research practices used by regulators, called federal guideline studies, with innovative research conducted at universities through grants from NIEHS.” CLARITY-BPA includes two components:
First Report on the CLARITY-BPA Core Study
A “Draft NTP Research Report on the CLARITY-BPA Core Study: A Perinatal and Chronic Extended-Dose-Range Study of Bisphenol A in Rats” was publicly released by the National Toxicology Program (NTP) in February 2018 and was reviewed by a panel of experts in April 2018. The NCTR-conducted two-year rat study was part of an NTP-led effort known as CLARITY-BPA — short for Consortium Linking Academic and Regulatory Insights on BPA Toxicity. As stated in NTP’s Update Newsletter, “NIEHS (National Institute of Environmental Health Sciences) and FDA convened CLARITY-BPA to study the full range of potential health effects from exposure to BPA in rats and to provide data that could be used for regulatory decisions. CLARITY-BPA united standard research practices used by regulators, called federal guideline studies, with innovative research conducted at universities through grants from NIEHS.” CLARITY-BPA includes two components:
1) core chronic rat study — conducted at FDA/NCTR
2) grantee studies — conducted by the academic researchers using biological samples provided by FDA/NCTR and that originated from the same core study.
The consortium involved 14 NIEHS-funded academic grantees and scientists from:
- NIEHS/NTP
- NIEHS/Division of Extramural Research and Training
- FDA/NCTR
- FDA/Center for Food Safety and Applied Nutrition.
The final Core Study Research Report is expected in August 2018. Follow the progress of CLARITY-BPA. For more information, contact K. Barry Delclos, Ph.D. or Luísa Camacho, Ph.D., Division of Biochemical Toxicology, FDA/NCTR.
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