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Geneoscopy Completes Pivotal Colorectal Cancer Trial Enrollment with Diverse Participant Population

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Trial Enrollment Over Indexes in Traditionally Under-Represented Black Community

ST. LOUIS /PRNewswire/ — Geneoscopy Inc., a life sciences company focused on the development of diagnostic tests for gastrointestinal health, today announced completed enrollment of the CRC-PREVENT pivotal trial for its noninvasive, at-home diagnostic screening test to detect colorectal cancer (CRC) and advanced adenomas in average-risk individuals. Through a decentralized recruitment strategy, Geneoscopy enrolled more than 14,000 individuals across all 48 continental United States, many from traditionally under-represented communities in clinical trials, in terms of gender, race, ethnicity, socioeconomic status, and geography.

Geneoscopy enrolled 14,000+ individuals, many from traditionally under-represented communities in clinical trials.

Of the participants:

  • More than a quarter were racial or ethnic minorities
    • 16% were Black or African American – an over-index proportionally based on:
      • Just 5% of U.S. clinical trial participants are Black1
      • 12% of the U.S. population is Black or African American2
    • 3% were Asian
    • 7% were Hispanic or Latino

According to the American Cancer Society, CRC disproportionately affects the Black community, where the incidence and mortality rates are the highest of any racial/ethnic group in the U.S. In fact, Black people are about 20 percent more likely to be diagnosed with CRC and about 40 percent more likely to die from CRC than most other groups.

“Too often, underserved communities face barriers that exclude them from participating in important clinical trials. Our decentralized recruitment strategy helped mitigate these challenges, resulting in a diverse group of participants that are representative of the individuals that may use our noninvasive CRC screening tool,” said Dr. Erica Barnell, Chief Science Officer and co-founder of Geneoscopy. “We were particularly encouraged to see a substantial number of Black participants in our trial. Unfortunately, these individuals have a greater chance of having and dying from CRC compared with other racial groups, and yet too often, are underrepresented in clinical research. We believe that basing advances in cancer screening and prevention on data from all Americans will build greater confidence in new screening tests and, ultimately, save more lives.”

Complete efficacy and enrollment findings from the trial will be presented later this year. These findings will support a Pre-market Approval application to the U.S. Food and Drug Administration by the end of 2022.

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About Colorectal Cancer & Screening

Responsible for over 50,000 deaths annually, colorectal cancer (CRC) is the second leading cause of cancer death in the United States. CRC usually begins as a growth (or polyp) that may or may not develop into cancer over time. Early detection and treatment are crucial to improve survival; however, many newly diagnosed patients suffer from advanced disease. Colonoscopy remains the gold standard for CRC screening in the U.S., yet this method is frequently met with patient aversion due to its required bowel preparation, sedation, and associated discomfort, resulting in low patient compliance. Currently available noninvasive screening methods lack sufficient sensitivity to reliably detect both early-stage CRC and high-risk precancerous lesions, including advanced adenomas which are a precursor in up to 70 percent of CRC cases.

About Geneoscopy Inc.

Geneoscopy Inc. is a life sciences company focused on the development of diagnostic tests for gastrointestinal health. Geneoscopy’s lead diagnostic uses stool-derived eukaryotic RNA (seRNA) to detect colorectal cancer and precancerous adenomas. This device was awarded Breakthrough Device Designation from the U.S. FDA for its ability to reduce morbidity associated with colorectal cancer through advanced adenoma detection. Indicative of its breakthrough status, initial trials suggest that the diagnostic can detect these lesions at a higher rate than that demonstrated by all existing noninvasive screening tests in their respective studies. Visit geneoscopy.com to learn more.

Geneoscopy Inc. Forward-Looking Statements

The information contained in this release includes information about Geneoscopy’s future plans concerning its noninvasive molecular test that can detect colorectal cancer and precancerous adenomas, and as such constitute forward-looking statements. These forward-looking statements are based on the Company’s reasonable estimates of future results or trends. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of the Company’s control. Geneoscopy’s actual results and financial condition may differ materially from those indicated in the forward-looking statements. Although the Company believes that its business plans and objectives reflected in or suggested by these forward-looking statements are reasonable, such plans or objectives may not be achieved, and the actual results may differ substantially from the projected results.

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SOURCE Geneoscopy Inc.

Rod is a blogger, writer, filmmaker, photographer, daydreamer who likes to cook. Rod produces and directs the web series, CUPIC: Diary of an Investigator. He is also the editor, producer and administrator of TNC Network.

Health

Observing World Cancer Day

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World Cancer Day is an international day marked on 4 February to raise awareness of cancer and to encourage its preventiondetection, and treatment. World Cancer Day is led by the Union for International Cancer Control (UICC) to support the goals of the World Cancer Declaration, written in 2008. The primary goal of World Cancer Day is to significantly reduce illness and death caused by cancer and is an opportunity to rally the international community to end the injustice of preventable suffering from cancer. The day is observed by the United Nations.

World Cancer Day targets misinformation, raises awareness, and reduces stigma. Multiple initiatives are run on World Cancer Day to show support for those affected by cancer. One of these movements are #NoHairSelfie, a global movement to have “hairticipants” shave their heads either physically or virtually to show a symbol of courage for those undergoing cancer treatment. Images of participants are then shared all over social media. Hundreds of events around the world also take place. (wikipedia)

https://stmdailynews.com/category/lifestyle/health-and-wellness/health/

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FDA CDC News

Food Safety Tips for Game Day

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/PRNewswire/ — Super Bowl Sunday is coming up and you may be planning a party with friends and family. These parties often involve finger foods, communal dishes, and treats that are left out for long periods of time—which can lead to foodborne illness (also known as food poisoning).  Don’t let foodborne illness ruin the fun. Check out these tips from the U.S. Food and Drug Administration and learn how you can keep your food safe.

Food Safety Tips for Game Day

CLEAN

  • Wash your hands with warm water and soap for at least 20 seconds before and after handling food and after using the bathroom, changing diapers, and handling pets.
  • Wash your cutting boards, dishes, utensils, and counter tops with hot soapy water after preparing each food item.
  • Rinse fresh fruits and vegetables under running tap water, including those with skins and rinds that are not eaten. Scrub firm produce with a clean produce brush.

SEPERATE

  • Separate raw meat, poultry, seafood, and eggs from other foods in your shopping cart, grocery bags, and refrigerator.
  • Use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
  • Never place cooked food on a plate that previously held raw meat, poultry, seafood, or eggs unless the plate has been washed in hot, soapy water.
  • Don’t reuse marinades used on raw foods unless you bring them to a boil first.
  • If baking, make sure that no raw flour is on surfaces that contact other foods.

COOK

  • Use a food thermometer to ensure the safety of meat, poultry, seafood, and egg products. These foods must be cooked to a safe minimum internal temperature to destroy any harmful bacteria.
  • When cooking in a microwave oven, cover food, stir, and rotate for even cooking. If there is no turntable, rotate the dish by hand once or twice during cooking. Always allow standing time, which completes the cooking, before checking the internal temperature with a food thermometer.

CHILL

  • Refrigerate or freeze meat, poultry, eggs, seafood, and other perishables within 2 hours of cooking or purchasing. Refrigerate within 1 hour if the temperature outside is above 90° F.
  • Divide large amounts of leftovers into shallow containers for quicker cooling in the refrigerator.

SERVE

  • Keep cold foods chilled to 40 °F or below and hot foods heated to 140 °F or above.
  • If you’re planning a buffet and aren’t sure how quickly the food will be eaten, keep serving portions small. Prepare a number of small platters and dishes ahead of time and replace the serving dishes with the fresh ones throughout the party.
  • Don’t add new food to an already filled serving dish. Instead, replace nearly empty serving dishes with freshly filled ones.
  • Watch the clock with leftovers. Whether you’re sending “doggie bags” home with guests or are saving them for yourself, leftovers should be refrigerated as soon as guests arrive home and/or within 2 hours!

Learn more at:
http://www.fda.gov/Food/FoodborneIllnessContaminants/BuyStoreServeSafeFood/ucm328131.htm

SOURCE U.S. Food and Drug Administration

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FDA CDC News

FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward

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Statement From:Janet Woodcock, M.D.
Principal Deputy Commissioner – Office of the Commissioner

January 26, 2023

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.  

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant. 

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

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The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive. 

The working group, which I chair, has closely examined studies related to the CBD-based drug Epidiolex, published scientific literatureinformation submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods. 

CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD. Because it is not apparent how CBD products could meet the safety standard for substances in animal food, we also do not intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate. We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.

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