SPECIAL FEATURE :: DIAGNOSTIC UPDATES
2023 diagnostic updates M
By MLO staff
edical Laboratory Observer connects laboratory profes- sionals with industry trends every year. There have been important diagnostic updates for laboratories
from the U.S. Food and Drug Administration and the National Institutes of Health in 2023 — MLO staff put this article together to summarize those updates for its readers. With this new research, medical experts are closer to identify-
ing better cancer treatments, determining blood donor eligibility, having a deeper understanding of long COVID, and diagnosing severe COVID-19 in pediatric patients.
FDA launches pilot program to help reduce risks associated with using laboratory developed tests to identify cancer biomarkers The U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain corresponding in vitro diagnostic tests to help clinicians select appropriate cancer treatments for patients. Through the pilot program, the FDA will request, from drug manufacturers, performance information for the tests used to enroll patients into the clinical trials that support drug approval. Based on an assessment of that information, the FDA will post to the FDA website the minimum perfor- mance characteristics recommended for similar tests that may be used to select patients for treatment with the approved drug. Laboratories may use this information to guide their development of LDTs to identify specific biomarkers used for selecting cancer treatment. This transparency aims to help facilitate better and more consistent performance of these tests, resulting in better drug selection and improved care for patients with cancer. As discussed in the guidance, the initial phase of the pilot program is anticipated to last up to one year, during which the FDA will evaluate no more than nine drug sponsors for possible acceptance into the pilot. The minimum recommended performance characteristics for in vitro diagnostic tests used with each approved drug product under the pilot, based on the clinical trial assays, will be made publicly available on the FDA’s website following drug approval.1
FDA finalizes move to recommend individual risk assessment to determine eligibility for blood donations The U.S. Food and Drug Administration finalized recommen- dations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfu- sion-transmitted HIV. These questions will be the same for every donor, regardless of sexual orientation, sex, or gender. Blood establishments may now implement these recommendations by revising their donor history questionnaires and procedures. These final recommendations are consistent with the policy
initially proposed in January 2023. This policy eliminates time-based deferrals and screening questions specific to men who have sex with men (MSM) and women who have sex with MSM. Under the final guidance issued, all prospective blood donors will answer a series of individual, risk-based questions to determine eligibility. All prospective donors who report having a new sexual partner, or more than one sexual partner in the past three months, and
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anal sex in the past three months, would be deferred to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period for detection of HIV by nucleic acid testing. Additionally, under these final recommendations, those taking medications to treat or prevent HIV infection (e.g., antiretroviral therapy (ART), pre-exposure prophylaxis (PrEP) and post-exposure prophylaxis (PEP)), will also be deferred. Though these antiretroviral drugs are safe, effective, and an important public health tool, the available data demonstrate that their use may delay detection of HIV by currently licensed screening tests for blood donations, which may potentially give false negative results. Although HIV is not transmitted sexually by individuals with undetectable viral levels, this does not apply to transfusion transmission of HIV because a blood transfusion is administered intravenously, and a transfusion involves a large volume of blood compared to exposure with sexual contact. As stated in the guidance, individuals should not stop taking their prescribed medications, including PrEP, or PEP, in order to donate blood.2
Large study provides scientists with deeper insight into long COVID symptoms Initial findings from a study of nearly 10,000 Americans, many of whom had COVID-19, have uncovered new details about long COVID, the post-infection set of conditions that can affect nearly every tissue and organ in the body. Clinical symptoms can vary and include fatigue, brain fog, and dizziness, and last for months or years after a person has COVID-19. The research team, funded by the National Institutes of Health, also found that long COVID was more common and severe in study participants infected before the 2021 Omicron variant. The study, published in JAMA, is coordinated through the
NIH’s Researching COVID to Enhance Recovery (RECOVER) initiative, a nationwide effort dedicated to understanding why some people develop long-term symptoms following COVID-19, and most importantly, how to detect, treat, and prevent long COVID. The researchers hope this study is the next step toward
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