Week in Review: Quest’s long COVID testing panels | DiaSorin’s 510(k) clearance | BioMérieux's strategic investment

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Dear LabPulse.com reader:

Nursing homes that conducted more frequent staff surveillance testing experienced significantly lower rates of COVID-19 infections and deaths among residents, according to a study published Wednesday in the New England Journal of Medicine. The findings suggest that frequent staff testing can protect vulnerable populations during a pandemic.

Although the declaration of a COVID-19 public health emergency in the U.S. is expected to end on May 11, nearly one in five American adults who had COVID-19 still suffer adverse side effects, otherwise known as long COVID, according to Centers for Diseases Control and Prevention (CDC) estimates. The condition has inspired extensive research to further our understanding of it, but relatively little has been written about diagnostic tests to help patients. This week, Quest Diagnostics introduced two panels for consumers that offer information about lingering health issues associated with previous COVID-19 virus infections. Specific tests that are part of the panels are outlined in this article.

With the end in sight to the declaration of a COVID-19 public health emergency, more companies are being granted traditional clearances to market their tests in the U.S. DiaSorin received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa COVID-19 & Flu A/B Direct assay. The Saluggia, Italy-based firm noted that its FDA-cleared menu for respiratory infections will provide long-term options to labs after the pandemic-related emergency use authorization (EUA) period has ended.

With one eye on COVID-19, the FDA is also seeking to help prevent the spread of the mpox virus, and earlier this week it granted an emergency use authorization (EUA) to Cue Health for its molecular test to detect the condition.

In other company news, Proxim Diagnostics received a strategic investment from Marcy-l'Étoile, France-based BioMérieux. Proxim, a Santa Clara, CA-based point-of-care diagnostic test developer, will use the funds to complete the development and commercialization of the Proxim Profile System, a portable and fully automated immunodiagnostic device that would run a variety of multiplexed assays with disposable cartridges.

A Duke University team said it has identified a set of biomarkers that could help distinguish whether cysts on the pancreas are likely to develop into pancreatic cancer or remain benign. The National Cancer Institute-funded study, published in the journal Science Advances, marked a first step toward a clinical approach for classifying lesions on the pancreas that are at the highest risk of becoming cancerous, potentially enabling their removal before they begin to spread.

Researchers have found that mailing human papillomavirus (HPV) self-sampling kits to women overdue for cervical cancer screening was cost-effective for increased screening uptake relative to usual care. Their study, published Wednesday in JAMA Network Open, supports mailing HPV kits as an efficient outreach strategy for increasing screening rates among eligible women.

A recent multisite survey of more than 8,000 patients who accessed medical test results via an online patient portal found that patients overwhelmingly preferred receiving those results immediately, even if their provider had not yet reviewed them. The study, involving a broad collaboration of researchers, was published Monday in JAMA Network Open.

Clinical investigators use real-world data (RWD) in randomized trials and observational studies to produce real-world evidence (RWE) used to assess the safety and efficacy of an intervention and to inform product development, regulatory approval, and post-market surveillance efforts. However, despite their information-rich potential, collecting RWD and producing RWE requires scientific vigilance. This article provides an overview of the most common types of statistical errors -- confounding, selection bias, and information bias -- in real-world studies and approaches for preventing and mitigating these errors.

The United States is not only the largest geographic market for healthcare products in the world, but also the largest market for in vitro diagnostic products. According to Kalorama Information, a LabPulse sister brand, in a newly released IVD Market Atlas, the U.S. IVD market reached $53 billion in 2022, or approximately 40% to 45% of the global market.

Thank you for reading.

Leo O’Connor

Editor in Chief

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