Latest news with #UKConformityAssessed
Business Wire
5 days ago
- Business
- Business Wire
ClearNote Health Receives First In Vitro Diagnostic Approval for its Avantect ® Pancreatic Cancer Test
SAN DIEGO--(BUSINESS WIRE)-- ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received UK Conformity Assessed (UKCA) marking for its Avantect ® Pancreatic Cancer Test. The UKCA mark, established as part of the United Kingdom's independent product safety regulatory framework following its departure from the European Union, signifies compliance with UK medical device regulations and paves the way for commercial availability in the UK market. 'Achieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health,' said Dave Mullarkey, CEO at ClearNote Health. The Avantect Pancreatic Cancer Test is an innovative blood test designed to detect pancreatic cancer at its earliest and most treatable stages. The test analyzes epigenomic and genomic data generated by sequencing circulating, cell-free DNA collected from a simple blood draw. It is designed to be part of a diagnostic evaluation, interpreted in the context of other clinical findings for the diagnosis of pancreatic cancer. As many as 15,000 patients in the UK recently gained access to the Avantect Pancreatic Cancer Test through the Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study. This landmark clinical trial is sponsored by the University Hospital Southampton, NHS Foundation Trust, and is being conducted by researchers at the Southampton Clinical Trials Unit at the University of Southampton. The UKCA mark paves the way for ClearNote Health and its distributors to offer the Avantect Pancreatic Cancer Test to UK patients who are not participating in the SAFE-D study. 'Achieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health,' said Dave Mullarkey, CEO at ClearNote Health. 'It represents the company's transition from laboratory-developed tests to formally regulated commercial diagnostics, reinforcing our commitment to quality, clinical rigor, and global regulatory standards. This approval lays the foundation for additional international expansion and broader patient access.' For more information on the Avantect Pancreatic Cancer Test, please visit About ClearNote Health ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company's patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company's highly sensitive, noninvasive Avantect ® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited, and New York State Department of Health-permitted laboratory are located in San Diego. For more information, visit or follow the company on Bluesky or LinkedIn.
South Wales Argus
16-06-2025
- Business
- South Wales Argus
Third of sunglasses on Amazon and more pose child eye risk
Which? bought 20 pairs of sunglasses for children and found that the UV protection levels were 'dangerously low' for two of them, despite claims they offered full protection. One third of sunglasses sold on platforms like Amazon and eBay could damage child eysight The UV protection levels were found to be inconsistent in many of these specs (Image: Getty Images) Some sunglasses were also found to offer significantly different protection from one lens to the other. Several models including Cute Cat Kids' Sunglasses UV Protection (£1.59 from Amazon), Classic Vintage Holiday Sunglasses UV400 (£3.99 on eBay), Kids' Aviators (£1.16 from AliExpress), Kids £1 Sunglasses (from Temu) and red heart-shaped sunglasses (£5.28 from eBay) all made either misleading claims about their ability to block UV rays or had inconsistent UV filtering. All of the sunglasses tested were found to be missing key information, labels and markings, such as CE or UK Conformity Assessed markings (UKCA), which are required for them to be sold in the UK legally. Which? director of policy and advocacy Rocio Concha said: 'With summer holidays approaching, it is understandable that parents will want to buy their children sunglasses, and kids and parents alike might be tempted by some of the cheap and trendy options sold online. 'Our research shows many of these models are so ineffective as to be dangerous for children to wear and this is a consequence of online marketplaces having no real responsibility or incentive for taking safety seriously. 'The Government's Product Regulation and Metrology Bill must be strengthened to include legal responsibilities for online marketplaces to ensure the products they sell on their sites are safe, with heavy fines for those that fall short of the required standards.' An Amazon spokesman said: 'Safety is a top priority, and we require all products offered in our store to comply with applicable laws, regulations and Amazon policies. 'We continuously monitor our store and take action to maintain a safe selection for our customers, including removing non-compliant products and reaching out to sellers, manufacturers, and government agencies for additional information. 'The products in question have been removed." AliExpress also said it had removed the items that failed Which?'s tests, adding: 'AliExpress takes product safety very seriously and we have strict rules and policies in place to ensure a safe online shopping environment.' A spokeswoman for eBay said: 'Consumer safety is a top priority. We proactively keep our site safe and prevent prohibited listings through seller compliance audits, block filter algorithms for unsafe listings, and AI-supported monitoring by our team of in-house specialists. 'If we find an unsafe product, we remove it immediately and alert buyers, which is the exact approach we took on April 4 2025, before Which? contacted us.' Temu said: 'We take product safety very seriously. All three flagged listings have been removed from the platform pending further review.' Recommended Reading: TikTok said: 'The safety of our customers is of our utmost priority, and we have strict measures in place to ensure that our sellers comply with regulations and safety standards. 'These listings have been removed from our platform.' Shein said: 'We take product safety very seriously and are committed to offering safe and reliable products to its customers. We immediately removed the items from our site as a precaution while we investigate.'
Fashion United
16-06-2025
- Business
- Fashion United
Third of children's sunglasses sold online pose 'serious risk'
A third of children's sunglasses bought from online marketplaces, including Amazon, AliExpress, Ebay, TikTok, Shein and Temu, do not provide the eye protection required and are unsafe to wear, according to a new investigation from Which?, a UK consumer champion that tests and reviews products. Which? researchers bought 20 pairs of kids' sunglasses from the six online marketplaces and found that UV protection levels were found to be dangerously low for two of the pairs tested, despite claiming to have full UV protection, while some offer significantly different protection from one lens to the other, when good sunglasses should offer the same protection in both lenses. It also noted that while several models look enticing, especially to children, with heart or cat-shaped lenses or vintage styles, they either made misleading claims about their ability to block UV rays or had inconsistent UV filtering. All of the sunglasses tested were found to be missing key information, labels and markings, such as CE or UK Conformity Assessed markings (UKCA), which are required for them to be sold in the UK legally. As a result, none of the 20 pairs of sunglasses bought from online marketplaces can be sold legally in the UK, said Which?, which has labelled the sunglasses as Don't Buys and would urge consumers to avoid them. Rocio Concha, director of policy and advocacy at Which?, said: 'With summer holidays approaching, it is understandable that parents will want to buy their children sunglasses, and kids and parents alike might be tempted by some of the cheap and trendy options sold online. 'Our research shows many of these models are so ineffective as to be dangerous for children to wear and this is a consequence of online marketplaces having no real responsibility or incentive for taking safety seriously. 'The government's Product Regulation and Metrology Bill must be strengthened to include legal responsibilities for online marketplaces to ensure the products they sell on their sites are safe, with heavy fines for those that fall short of the required standards.' In response to the research, an Amazon spokesperson added: 'Safety is a top a priority, and we require all products offered in our store to comply with applicable laws, regulations and Amazon policies. We continuously monitor our store and take action to maintain a safe selection for our customers, including removing non-compliant products and reaching out to sellers, manufacturers, and government agencies for additional information. 'If customers have concerns about an item they've purchased, we encourage them to contact our Customer Service directly so we can investigate and help resolve their issue. The products in questions have been removed.' AliExpress, Shein, Temu and TikTok told Which? that it had removed the items that failed the tests from its platforms, while Ebay stated it was 'proactively' preventing prohibited listings through seller compliance audits, block filter algorithms for unsafe listings, and AI-supported monitoring by our team of in-house specialists.
Powys County Times
16-06-2025
- Business
- Powys County Times
Third of sunglasses on Amazon and more pose child eye risk
One third of sunglasses sold on platforms like Amazon, eBay, AliExpress and Shein pose an eyesight risk to children, according to research carried out by a trusted consumer watchdog. Which? bought 20 pairs of sunglasses for children and found that the UV protection levels were 'dangerously low' for two of them, despite claims they offered full protection. One third of sunglasses sold on platforms like Amazon and eBay could damage child eysight Some sunglasses were also found to offer significantly different protection from one lens to the other. Several models including Cute Cat Kids' Sunglasses UV Protection (£1.59 from Amazon), Classic Vintage Holiday Sunglasses UV400 (£3.99 on eBay), Kids' Aviators (£1.16 from AliExpress), Kids £1 Sunglasses (from Temu) and red heart-shaped sunglasses (£5.28 from eBay) all made either misleading claims about their ability to block UV rays or had inconsistent UV filtering. All of the sunglasses tested were found to be missing key information, labels and markings, such as CE or UK Conformity Assessed markings (UKCA), which are required for them to be sold in the UK legally. Which? director of policy and advocacy Rocio Concha said: 'With summer holidays approaching, it is understandable that parents will want to buy their children sunglasses, and kids and parents alike might be tempted by some of the cheap and trendy options sold online. 'Our research shows many of these models are so ineffective as to be dangerous for children to wear and this is a consequence of online marketplaces having no real responsibility or incentive for taking safety seriously. 'The Government's Product Regulation and Metrology Bill must be strengthened to include legal responsibilities for online marketplaces to ensure the products they sell on their sites are safe, with heavy fines for those that fall short of the required standards.' An Amazon spokesman said: 'Safety is a top priority, and we require all products offered in our store to comply with applicable laws, regulations and Amazon policies. 'We continuously monitor our store and take action to maintain a safe selection for our customers, including removing non-compliant products and reaching out to sellers, manufacturers, and government agencies for additional information. 'The products in question have been removed." AliExpress also said it had removed the items that failed Which?'s tests, adding: 'AliExpress takes product safety very seriously and we have strict rules and policies in place to ensure a safe online shopping environment.' A spokeswoman for eBay said: 'Consumer safety is a top priority. We proactively keep our site safe and prevent prohibited listings through seller compliance audits, block filter algorithms for unsafe listings, and AI-supported monitoring by our team of in-house specialists. 'If we find an unsafe product, we remove it immediately and alert buyers, which is the exact approach we took on April 4 2025, before Which? contacted us.' Temu said: 'We take product safety very seriously. All three flagged listings have been removed from the platform pending further review.' TikTok said: 'The safety of our customers is of our utmost priority, and we have strict measures in place to ensure that our sellers comply with regulations and safety standards. 'These listings have been removed from our platform.'
The Herald Scotland
16-06-2025
- Business
- The Herald Scotland
Third of sunglasses on Amazon and more pose child eye risk
One third of sunglasses sold on platforms like Amazon and eBay could damage child eysight The UV protection levels were found to be inconsistent in many of these specs (Image: Getty Images) Some sunglasses were also found to offer significantly different protection from one lens to the other. Several models including Cute Cat Kids' Sunglasses UV Protection (£1.59 from Amazon), Classic Vintage Holiday Sunglasses UV400 (£3.99 on eBay), Kids' Aviators (£1.16 from AliExpress), Kids £1 Sunglasses (from Temu) and red heart-shaped sunglasses (£5.28 from eBay) all made either misleading claims about their ability to block UV rays or had inconsistent UV filtering. All of the sunglasses tested were found to be missing key information, labels and markings, such as CE or UK Conformity Assessed markings (UKCA), which are required for them to be sold in the UK legally. Which? director of policy and advocacy Rocio Concha said: 'With summer holidays approaching, it is understandable that parents will want to buy their children sunglasses, and kids and parents alike might be tempted by some of the cheap and trendy options sold online. 'Our research shows many of these models are so ineffective as to be dangerous for children to wear and this is a consequence of online marketplaces having no real responsibility or incentive for taking safety seriously. 'The Government's Product Regulation and Metrology Bill must be strengthened to include legal responsibilities for online marketplaces to ensure the products they sell on their sites are safe, with heavy fines for those that fall short of the required standards.' An Amazon spokesman said: 'Safety is a top priority, and we require all products offered in our store to comply with applicable laws, regulations and Amazon policies. 'We continuously monitor our store and take action to maintain a safe selection for our customers, including removing non-compliant products and reaching out to sellers, manufacturers, and government agencies for additional information. 'The products in question have been removed." AliExpress also said it had removed the items that failed Which?'s tests, adding: 'AliExpress takes product safety very seriously and we have strict rules and policies in place to ensure a safe online shopping environment.' A spokeswoman for eBay said: 'Consumer safety is a top priority. We proactively keep our site safe and prevent prohibited listings through seller compliance audits, block filter algorithms for unsafe listings, and AI-supported monitoring by our team of in-house specialists. 'If we find an unsafe product, we remove it immediately and alert buyers, which is the exact approach we took on April 4 2025, before Which? contacted us.' Temu said: 'We take product safety very seriously. All three flagged listings have been removed from the platform pending further review.' Recommended Reading: TikTok said: 'The safety of our customers is of our utmost priority, and we have strict measures in place to ensure that our sellers comply with regulations and safety standards. 'These listings have been removed from our platform.' Shein said: 'We take product safety very seriously and are committed to offering safe and reliable products to its customers. We immediately removed the items from our site as a precaution while we investigate.'
