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European Commission Proposes Delays for IVDR to Avoid Supply Disruptions

The European Union originally intended to implement the IVDR starting in May 2022. However, concerns that some tests would not have IVDR certificates by that date prompted authorities to establish a new, staggered timeline in October 2021. The revised timeline gave manufacturers of high-risk Class D in vitro diagnostics until May 2025 to meet the requirements. As the certification of Class D products typically takes between 13 and 24 months, manufacturers who have not yet applied to a notified body may not be able to meet the deadline of May 2025. MedTech Europe is among the organizations that have expressed concerns about the Class D timeline and made suggestions on how to reduce the risk of IVDR disrupting the test supply. The Commission has recognized the danger and stated that… 

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BD Partners with Techcyte to Offer AI-Powered Cervical Cancer Screening

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According to the World Health Organization, cervical cancer was responsible for an estimated 342,000 deaths worldwide in 2020. Limited access to screening is one reason why people still die from cervical cancer. BD supports screening with its human papillomavirus (HPV) test and the Surepath liquid-based Pap test. Although HPV tests are more sensitive, according to the company, it expects Pap tests to "continue to play an important diagnostic role as programs transition to the new standard of care. Techcyte's system is compatible with several liquid-based cytology preparations, including Surepath. Traditionally, cytotechnologists and pathologists viewed glass slides under a microscope. To use the Techcyte system, technologists prepare slides with systems like Surepath and scan them to create digital files. The AI algorithm then identifies cells with features that suggest they may be diagnostically relevant."

Untire app now prescribable for breast cancer

The health app Untire has been provisionally included in the directory of Digital Health Applications (DiGA) of the Federal Institute for Drugs and Medical Devices (BfArM). It is the first DiGA specifically for tumor-associated fatigue. Effective immediately, doctors and psychotherapists can prescribe this digital therapy to their breast cancer patients on prescription. Breast cancer (mammary carcinoma) is the most common cancer in women in Germany. More than 70,000 people fall ill with it each year, and the 10-year prevalence is 570,900.[1] The most common accompanying condition of the disease and its treatment is so-called tumor-associated fatigue (CRF), also known as cancer-related fatigue, which significantly impairs the general well-being of those affected. There is currently no drug treatment available. Untire is the first DiGA to help breast cancer patients reduce their exhaustion. In the Netherlands and Great Britain, 40,000 cancer patients are already using the app. With its inclusion in the BfArM's DiGA directory, Untire can...

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Animal testing-free method for safety assessment of cancer therapies is launched

Scientists at the University Hospital Freiburg have received funding of one million pounds, equivalent to around 1.17 million euros, as part of the British "Crack it" challenge. The team, led by Prof. Dr. Toni Cathomen, Director of the Institute for Transfusion Medicine and Gene Therapy at the University Hospital Freiburg, is researching an innovative approach to assessing the safety of modern cancer therapies. The new method is intended to help replace animal testing and improve the safety of CAR T-cell therapy. The "Crack it" challenge funding program is awarded annually by the British research organization NC3Rs with a maximum of one million pounds and aims to reduce animal testing. CAR T-cell therapies are already used in numerous cancer diseases and offer great potential for treating patients with previously incurable cancers. This involves taking the patient's own immune cells (T-cells) and modifying them in the laboratory so that they can specifically recognize and fight cancer cells. To reduce the likelihood of side effects and complications...

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German Cancer Aid Award for 2023 Presented

German Cancer Aid presented the German Cancer Aid Award for 2023 during a ceremony in the Old Town Hall in Bonn. The award recipients are Professor Dr. Reinhard Büttner, Professor Dr. Jürgen Wolf, and Professor Dr. Roman Thomas from Cologne. They are receiving the award in recognition of their outstanding work in the field of diagnostics and therapy for lung cancer – particularly within the framework of the interdisciplinary 'National Network Genomic Medicine (nNGM) – Lung Cancer' initiated by them. It enables patients with advanced lung cancer to receive a personalized therapy tailored precisely to them. The German Cancer Aid Award is endowed with 15,000 euros for each recipient. The interdisciplinary 'National Network Genomic Medicine Lung Cancer' has developed into the world's largest lung cancer initiative since 2018. It originated from the Cologne network 'Genomic Medicine,' which has been successfully advocating for the implementation of personalized therapies in the care of patients with advanced...

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