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FDA Grants First DNA Test for Dozens of Cancer Types

FDA grants marketing authorization for DNA test assessing predisposition for multiple cancer types.

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The U.S. Food and Drug Administration (FDA) has recently made a groundbreaking announcement by granting the first marketing authorization for a DNA test that assesses predisposition for dozens of cancer types. This significant development comes in the form of the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test capable of detecting genetic variants associated with an elevated risk of developing certain cancers. This test marks a major advancement in personalized medicine, as it can evaluate DNA samples to identify variants in 47 genes known to be linked with an increased likelihood of developing specific types of cancer.

By utilizing next-generation sequencing technology, the Invitae Common Hereditary Cancers Panel offers a comprehensive assessment of multiple genes in a single test. This enables healthcare professionals to gain valuable insights into an individual’s genetic predisposition for certain cancers. With this information, physicians can provide appropriate monitoring and potential therapies tailored to each patient’s specific needs.

Cancer remains one of the leading causes of death in the United States, and the availability of this test brings a vital public health tool into the hands of medical professionals. It equips them with additional information to guide patient care, potentially leading to earlier detection and intervention for those at higher risk. However, it is important to note that this test does not evaluate all known cancer-related genes, and patients should consult with a healthcare professional to interpret the results accurately.

The Invitae Common Hereditary Cancers Panel underwent rigorous evaluation by the FDA under the De Novo premarket review pathway. Extensive testing, involving over 9,000 clinical samples, demonstrated an accuracy rate of ≥99.0% for all tested variant types. While the test carries the possibility of false positive and false negative results, the risks are mitigated by the analytical and clinical performance validation, along with appropriate labeling.

In addition to granting marketing authorization, the FDA has established special controls that define requirements related to labeling and performance testing. These measures ensure the safety and effectiveness of similar devices in the future, potentially expediting the regulatory process for subsequent tests.

The FDA’s decision to grant marketing authorization for the Invitae Common Hereditary Cancers Panel is a significant milestone in the field of genetic testing and personalized medicine. It offers individuals valuable information about their health, empowering them to make informed decisions regarding monitoring and potential therapies. As technology continues to advance, such tests have the potential to revolutionize cancer care by enabling earlier detection and personalized treatment strategies.

Read the press release here: https://www.fda.gov/news-events/press-announcements/fda-grants-first-marketing-authorization-dna-test-assess-predisposition-dozens-cancer-types?utm_medium=email&utm_source=govdelivery

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Lifestyle

Important Recall Alert: Expanded Produce Recall Due to Listeria Concerns

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In a significant public health alert, the Ohio Department of Agriculture (ODA) has announced an expanded recall of fresh produce supplied by Wiers Farm Inc., based in Huron County. This comes amidst growing concerns about potential listeria contamination, prompting vigilance among consumers shopping at select retailers, including Walmart, Aldi, and Kroger stores across Ohio and several other states.

people at supermarket. recall
Photo by Sebastián Mera Jaramillo on Pexels.com

What You Need to Know

On July 22, 2024, Wiers Farm Inc. expanded its voluntary recall to include additional produce items that were packed between July 5 and July 12. While there have been no reported illnesses or consumer complaints to date, the ODA is taking proactive measures to ensure public safety.

Affected Products

The recall includes a variety of retail packaged items and bulk produce sold at various grocery chains. Here’s a comprehensive list of the impacted products:

Retail Packaged Items

Sold at select Walmart stores in multiple states:

  • Wiers Farm Bagged Poblano – UPC 073064202581 – 16 oz bag
  • Wiers Farm Bagged Cubanelle – UPC 073064201836 – 16 oz bag
  • Wiers Farm Bagged Green Beans – UPC 073064200846 – variable weight bag
  • Wiers Farm Bagged Salad Cucumber – UPC 073064459619 – 2 lb. bag
  • Wiers Farm Bagged Serrano – UPC 073064201829 – 4 oz bag
  • Wiers Farm Organic Bell Pepper – UPC 073064201416 – 2 count tray
  • Wiers Farm Organic Cucumber – UPC 073064201423 – 2 count tray
  • Wiers Farm Organic Yellow Squash – UPC 073064201447 – 2 count tray
  • Wiers Farm Organic Zucchini Squash – UPC 073064201430 – 2 count tray

Sold at Aldi stores in Ohio and nearby states:

  • Freshire Farms Bagged Green Beans – 16 oz bag
  • Freshire Farms Bagged Jalapenos – 8 oz bag

Bulk Retail Items (sold individually or by the pound)

  • Anaheim peppers
  • Cilantro (sold in bunches)
  • Cubanelle peppers
  • Whole cucumbers
  • Green beans
  • Green Bell Pepper
  • Habanero peppers
  • Hungarian Wax peppers
  • Jalapeno peppers
  • Mustard Greens (sold in bunches)
  • Poblano peppers
  • Serrano peppers
  • Tomatillos

In Ohio, these bulk items were distributed to Walmart, Kroger, Save-a-Lot, and local food banks in Cleveland and Youngstown.

What Should Consumers Do?

The ODA is urging consumers who may have purchased any of the listed products to discard them immediately. It’s crucial to stay informed, as listeria monocytogenes can lead to serious health issues, particularly in vulnerable populations such as pregnant women, the elderly, and those with weakened immune systems. Symptoms of listeriosis can include fever, muscle aches, and gastrointestinal distress—anyone experiencing these symptoms after consuming the recalled products should seek medical attention promptly.

Commitment to Safety

Wiers Farm Inc. has expressed its dedication to resolving this situation and ensuring the safety of its products. The ODA is actively investigating the matter, a response initiated after potential contamination was flagged during routine testing by the Michigan Department of Agriculture and Rural Development.

Stay Informed

For further inquiries or concerns, consumers can reach out to Wiers Farm at 419-933-2161. It’s essential to stay updated on recalls and food safety alerts to protect your health and the health of your loved ones.

As we navigate through these recalls, let’s remain vigilant and prioritize food safety to ensure a healthy dining experience for everyone. Remember, when in doubt, it’s better to be safe than sorry—check your pantry and fridge today!

Related links:

https://agri.ohio.gov/divisions/food-safety/recalls/7-16-2024-wiers-farm-inc

https://www.wkyc.com/article/money/personal-finance/recalls/produce-recall-cucumbers-ohio-walmart-aldi-kroger-wiers-farm-willard/95-e394619e-114e-4b9d-ae80-6e6470bb9c9a

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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Consumer Corner

Important Recall Notice: Wiers Farm, Inc. Announces Voluntary Recall of Cucumbers Due to Listeria Concerns

Wiers Farm recalls cucumbers due to Listeria risk. Discard affected products immediately.

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In a decisive move to ensure consumer safety, Wiers Farm, Inc., a respected distributor based in Willard, OH, has announced a voluntary recall of select cucumber products over concerns of potential contamination with Listeria monocytogenes. This recall specifically targets a limited number of whole and bagged salad cucumbers, sourced from out of state and distributed under the Wiers Farm brand.

Recall Details

Date of Announcement: July 12, 2024
FDA Publish Date: July 16, 2024
Product Types: Whole cucumbers and 2 lb bagged salad cucumbers
Pack Dates: June 5, 2024 (whole cucumbers), June 5 and 6, 2024 (salad cucumbers)
Distribution: Select Walmart stores in Michigan, Indiana, and Ohio

Reason for Recall

The potential for contamination was identified through routine sampling by the Michigan Department of Agriculture and Rural Development (MDARD). While no illnesses or customer complaints have been reported to date, Wiers Farm is proceeding with the utmost caution to safeguard its customers.

About Listeria

Listeria monocytogenes is a bacteria capable of causing the serious infection known as listeriosis. It primarily affects pregnant women, newborns, the elderly, and adults with weakened immune systems. Symptoms include fever, muscle aches, nausea, and diarrhea. If you have consumed any of the recalled products and are experiencing these symptoms, it is advised to seek medical attention promptly. More information about Listeria can be found on the Centers for Disease Control and Prevention (CDC) website.

Product Identification

Whole Cucumbers: Approximately 1.5-2.5 inches in diameter and 6-9 inches in length
Bagged Salad Cucumers: Packaged in a clear bag with a blue base, marked with the specified pack dates

Consumer Action

Consumers in possession of the affected cucumbers are urged not to consume them. Even though the products are past their shelf life and likely out of distribution, if you still have them, please safely dispose of them immediately. Questions or concerns can be addressed by contacting Wiers Farm customer care at (419) 933-2161 or via email at customercare@wiersfarm.com.

Company Statement

Wiers Farm has expressed its commitment to the highest standards of food safety and health. “We have taken immediate steps to address this isolated incident and are collaborating closely with the Ohio Department other traceability data to ensure that the product in question is swiftly and effectively removed from all channels,” stated a company spokesperson.

Summary

This recall serves as a reminder of the importance of stringent safety measures in the food distribution process. Wiers Farm’s proactive steps in recalling potentially affected products underscore their dedication to consumer safety and health standards. Consumers are advised to follow recall instructions and dispose of any questionable products to ensure health and safety.

FDA notice: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/wiers-farm-inc-issues-voluntary-recall-whole-and-salad-cucumbers-due-possible-contamination-listeria

Our Lifestyle section on STM Daily News is a hub of inspiration and practical information, offering a range of articles that touch on various aspects of daily life. From tips on family finances to guides for maintaining health and wellness, we strive to empower our readers with knowledge and resources to enhance their lifestyles. Whether you’re seeking outdoor activity ideas, fashion trends, or travel recommendations, our lifestyle section has got you covered. Visit us today at https://stmdailynews.com/category/lifestyle/ and embark on a journey of discovery and self-improvement.

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FDA CDC News

Immediate Recall Alert: Reser’s Fine Foods Announces Voluntary Recall of Hill Country Fare Mustard Potato Salad

Reser’s recalls Hill Country Fare Mustard Potato Salad due to potential plastic contamination. Return for a refund if purchased.

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In a decisive action prioritizing consumer safety, Reser’s Fine Foods has issued a voluntary recall for one of its popular products, the Hill Country Fare Mustard Potato Salad, available in 48 oz (3LB) containers. This recall specifically targets products with a Use By Date of JUL/26/24. The reason behind this precautionary step is the discovery of potential contamination from pieces of hard plastic, which could present a health risk to consumers.

Key Details of the Mustard Potato Salad Recall:

  • Company Announcement Date: July 02, 2024
  • FDA Publish Date: July 09, 2024
  • Product Type: Food & Beverages
  • Reason for Recall: Possibility of Hard Plastic Foreign Material
  • Company Name: Reser’s Fine Foods
  • Brand Name: Hill Country Fare
  • Product Description: Mustard Potato Salad

This product was exclusively distributed through H-E-B and Joe V’s Smart Shop stores located within Texas and was produced at a regional facility operated by Reser’s Fine Foods. It is important to note that, fortunately, no injuries or adverse effects have been reported as of now.


Consumer Safety Measures

To prevent any potential hazards, all affected product batches have been removed from retail shelves. Reser’s urges consumers who have purchased this specific product to avoid consuming it. Instead, they should return it to the store where it was purchased for a full refund or safely dispose of it.

Contact Information for Consumer Inquiries:

For those with further questions or in need of additional information regarding this recall, Reser’s Fine Foods has made provisions for customer communication. You can reach them at:

  • Phone: 888-223-2127
  • Operational Hours: Monday to Friday, from 8:00 AM to 5:00 PM Pacific Time.

Why This Recall Matters

Recalls are a vital part of ensuring safety in the food supply chain. Reser’s Fine Foods has taken this proactive step out of an abundance of caution to protect its consumers from any possible harm. Such actions reflect a commitment to high standards of food safety and consumer protection.

Taking Action

If you have purchased the recalled Hill Country Fare Mustard Potato Salad, check the packaging for the specified Use By Date, and follow the outlined safety guidelines. It’s also wise to keep abreast of updates from Reser’s Fine Foods and the FDA.

This voluntary recall showcases the importance of rigorous quality checks and responsiveness in addressing any potential risk swiftly. For continued safety, keep informed about the latest food recalls and guidelines issued by health and food safety organizations.

Closing Thoughts

Reser’s Fine Foods remains dedicated to upholding the highest levels of safety and quality and is actively working on measures to prevent future issues. Consumers can rest assured that swift actions like these reflect a commitment to their well-being.

For continuous updates, stay tuned to the FDA’s announcements or sign up for direct alerts from food safety authorities to ensure you and your lovedators are always protected.

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/resers-fine-foods-announces-voluntary-recall-hill-country-fare-mustard-potato-salad-use-date-jul2624

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Visit our Food & Drink section to get the latest on Foodie News and recipes, offering a delightful blend of culinary inspiration and gastronomic trends to elevate your dining experience.

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