Industry Watch

 Published: November 23, 2021

By: Debbie Bunch


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FDA Issues Update on Philips Respironics Recall

Last June, problems with polyester-based polyurethane foam in certain ventilators, CPAP, and BiPAP devices made by Philips Respironics prompted a nationwide recall of the devices to replace the polyester-based polyurethane foam with silicone-based foam. However, in a recent inspection of a Philips Respironics manufacturing facility, the FDA found one instance in which silicone-based foam used in a device marketed outside of the U.S. failed a safety test for the emission of volatile organic compounds. The FDA has directed the company to retain an independent laboratory to perform additional testing to determine what, if any, potential safety risks may be posed to patients by the silicone-based foam, but is stopping short of recommending that patients who have participated in the repair and replace program discontinue use of their devices at this time. “We recognize that patients rely on these devices, and we are closely monitoring the company’s actions to ensure that the issues are resolved in a timely manner given the impact on patients,” said Jeff Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health. Read More

AstraZeneca Supports Research for Early NSCLC

AstraZeneca has issued new funding to the National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) for the support of several new projects aimed at improving care and outcomes for people with early-stage non-small cell lung cancer (NSCLC). Several of the projects will be designed to improve lung cancer screening for people at high risk for the disease, including one that will be carried out by City of Hope to implement an early lung cancer detection and navigation program in an underserved population. “We are honored to partner with NCCN ORP to fund projects that will advance high quality care and improved outcomes in individuals with an early stage non-small cell lung cancer,” said Nabil Chehab, PhD, U.S. medical affairs franchise head for lung cancer at AstraZeneca. “Our goal is always to ensure oncology clinicians are able to deliver the best treatment at the right time and we look forward to the results of these efforts.” Read More


New Kit Identifies Broader Range of CF Gene Variants

According to Bio-Techne Corporation, the Bio-Techne brand Asuragen, Inc., has launched a new kit to detect pathogenic variants in the CFTR gene that leads to cystic fibrosis. Intended for research use only, the kit provides broader coverage of the diverse U.S. population than other commercially available, targeted CFTR testing assays. Since variants identified in recent population genomics studies are included, the kit can detect about 93% of the CFTR pathogenic variants observed in the U.S. “We are committed to ensuring that our Asuragen kits consistently deliver the most reliable information across all populations,” said Kim Kelderman, president of the Diagnostics and Genomics Segment. Current assays are more likely to identify pathogenic variants in people of European descent and less likely to pick up those in individuals with non-European ancestry. Read More

NIH funds study on new diagnostic method for malignant lung nodules

The NIH has issued a five-year, $2.4 million grant to Binghamton University Assistant Professor Yuan Wan for the development of a procedure to simplify the diagnosis of malignant solitary pulmonary nodules (SPNs). The procedure will involve taking a blood sample from the patient, extracting the vesicles from the plasma, then enriching them using specially designed microfluidic devices. “If we can collect these vesicles and use a very high-sensitivity detection technology, we probably can tell if there is some abnormal information from the extracellular vesicles and give a diagnosis about whether it’s a tumor or just benign based on the mutation information,” he said. The effectiveness of the new tests will be measured against tissue samples collected from patients with SPNs. Read More

Oral COVID-19 medication under study for prevention too

The Merck antiviral oral medication, molnupiravir, has been found to be effective in treating people with COVID-19 and is now being used in the U.K. A new study will attempt to determine if the pill can also protect unvaccinated people living with a person with COVID-19 from contracting the disease. The randomized, double-blind, placebo-controlled study will include about 1,300 people at 114 sites around the world who will receive either the active treatment or a placebo for five days. “Based on results of a recent Centers for Disease Control and Prevention study involving the highly transmissible delta variant, we estimate that unvaccinated people living with a person with COVID-19 have a high risk — as great as an 80% to 100% chance — of becoming infected, regardless of their age or preexisting conditions,” said Barry Zingman, MD, principal investigator for the Montefiore Health System/Albert Einstein College of Medicine trial site. “If molnupiravir can prevent these vulnerable close contacts from becoming infected, it will save lives.” Read More

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Debbie Bunch

Debbie Bunch is an AARC contributor who writes feature articles, news stories, and other content for Newsroom, the AARC website, and associated emailed newsletters. In her spare time, she enjoys reading, traveling, photography, and spending time with her children and grandchildren. Connect with Debbie by email or on AARConnect or LinkedIn.

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