FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations
FDA finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-transmitted HIV.
DETAILS: The U.S. Food and Drug Administration finalized recommendations for assessing blood donor eligibility using a set of individual risk-based questions to reduce the risk of transfusion-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.
This updated policy is based on the best available scientific evidence and is in line with policies in place in countries like the United Kingdom and Canada. It will potentially expand the number of people eligible to donate blood, while also maintaining the appropriate safeguards to protect the safety of the blood supply.
These final recommendations are consistent with the policy initially proposed in January. The FDA worked diligently to review and consider all comments submitted to the agency to finalize these recommendations as quickly as possible. "The FDA has worked diligently to evaluate our policies and ensure we had the scientific evidence to support individual risk assessment for donor eligibility while maintaining appropriate safeguards to protect recipients of blood products. The implementation of these recommendations will represent a significant milestone for the agency and the LGBTQI+ community," said Peter Marks, M.D., PhD., director of the FDA’s Center for Biologics Evaluation and Research. "The FDA is committed to working closely with the blood collection industry to help ensure timely implementation of the new recommendations and we will continue to monitor the safety of the blood supply once this individual risk-based approach is in place."
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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 today, 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 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. The FDA remains committed to evaluating additional data and new technological developments as they become available to inform our donor eligibility recommendations.
The FDA has been evaluating alternatives to time-based deferrals for MSM and helping to facilitate the generation of scientific evidence that would support an individual risk based- assessment blood donor questionnaire. This scientific information has given the agency a solid foundation to support this new policy. The FDA strongly believes the implementation of an individual risk-based approach will not adversely affect the safety or availability of the U.S. blood supply.
The FDA carefully reviewed numerous data sources, including data from countries with similar HIV epidemiology that have implemented an individual risk-based approach for assessing donor eligibility, surveillance information obtained from the Transfusion Transmissible Infections Monitoring System, performance characteristics of nucleic acid testing for HIV and the FDA-funded Assessing Donor Variability And New Concepts in Eligibility study. The ADVANCE study examined the rates of HIV risk factors, such as anal sex and rates of HIV infection, as well as the usage of medications to treat or prevent HIV infection, among MSM study participants.
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Source: FDA Finalizes Move to Recommend Individual Risk Assessment to Determine Eligibility for Blood Donations. FDA. Published: May 11, 2023.
Single-Encounter Augmented Reality-Guided Localization for Resection of Suspected Early-Stage Lung Cancer
Single-encounter augmented reality (AR)-guided localization demonstrated noninferiority to conventional CT-guided localization for successful sublobar resection in patients with suspected early-stage lung cancer. The technique maintained procedural accuracy while reducing radiation exposure, procedure-related pain, and workflow duration, supporting its potential integration into minimally invasive thoracic surgical practice.
KEY FINDINGS: This randomized clinical trial demonstrated that single-encounter AR-guided localization was noninferior to conventional CT-guided localization for achieving successful sublobar resection of suspected early-stage lung cancer. In addition to maintaining localization accuracy, the AR-guided approach reduced radiation exposure, procedural pain, and workflow time, supporting its potential as an alternative localization strategy for minimally invasive lung surgery.
BACKGROUND: Accurate preoperative localization is critical for successful sublobar resection of small pulmonary nodules suspicious for early-stage lung cancer. Conventional computed tomography (CT)-guided localization typically requires multiple encounters, including localization in the CT suite followed by transfer to the operating room, increasing patient discomfort, radiation exposure, and procedural complexity. This randomized clinical trial evaluated whether a single-encounter augmented reality (AR)-guided localization strategy could achieve surgical outcomes comparable to standard CT-guided localization while improving procedural efficiency and patient experience.
DETAILS: This multicenter, randomized, noninferiority trial was conducted at 5 centers in China between August 8, 2024, and September 30, 2025. Among 296 randomized patients, 270 were included in the modified intention-to-treat analysis, with 134 assigned to single-encounter AR-guided localization and 136 to conventional multiple-encounter CT-guided localization. Eligible participants had CT-detected pulmonary nodules suspicious for early-stage lung cancer requiring preoperative localization before sublobar resection. The primary endpoint was successful sublobar resection, defined as R0 resection with protocol-specified adequate surgical margins. Secondary outcomes included localization accuracy, radiation exposure, localization-related complications, patient-reported pain, and procedural efficiency. The median (IQR) patient age was 59 (50-67) years, and 172 participants (63.7%) were women. Successful sublobar resection was achieved in 132 of 134 AR-guided procedures (98.5%) and 135 of 136 CT-guided procedures (99.3%), yielding a risk difference of -0.8 percentage points (95% CI, -2.7 to 3.9) and meeting the prespecified criterion for noninferiority. Localization accuracy was similar between groups, with a median (IQR) localization error of 3.0 (0.0-5.0) in the AR group and 3.0 (2.0-6.0) in the CT group. Compared with CT guidance, AR-guided localization significantly reduced radiation exposure (456.50 [378.75-631.85] vs 1260.11 [1026.48-1544.53] mGy·cm; P<.001), preoperative pain (0 [0-0] vs 5 [4-6]; P<.001), puncture time (0.63 [0.50-0.83] vs 6.50 [5.00-8.75] minutes; P<.001), and localization-to-incision interval (2.00 [1.50-2.00] vs 33.50 [18.00-63.00] minutes; P<.001). Pneumothorax occurred in 40 of 136 CT-guided cases (29.4%), whereas no clinically significant complications associated with AR-guided localization were reported.
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Gadolinium-Based Contrast Agents: Reassessing Safety Beyond Nephrogenic Systemic Fibrosis
This review highlights that gadolinium-based contrast agents continue to play a critical role in diagnostic MRI, but their use should be guided by careful patient selection and individualized risk assessment. Although the risk of nephrogenic systemic fibrosis has declined considerably, further research is needed to clarify the clinical significance of gadolinium retention and its long-term safety.
KEY FINDINGS: This review emphasizes that GBCAs remain indispensable for diagnostic MRI but should be used following an individualized benefit-risk assessment, particularly in patients with chronic kidney disease or acute kidney injury. Although modern practice has substantially reduced the incidence of NSF, uncertainties remain regarding gadolinium retention, long-term toxicity, and persistent symptoms after exposure. Continued research into the mechanisms of gadolinium-associated injury, along with transparent patient counseling and evidence-based imaging policies, will be essential to optimize both patient safety and diagnostic care.
BACKGROUND: Gadolinium-based contrast agents (GBCAs) have been widely used to enhance magnetic resonance imaging (MRI) since the 1980s because of their favorable diagnostic performance and generally low incidence of acute adverse reactions. However, concerns regarding nephrogenic systemic fibrosis (NSF), gadolinium retention, and potential long-term toxicity have prompted ongoing debate about their safety, particularly in patients with kidney disease. This review examines current evidence on GBCA-associated complications, mechanisms of toxicity, and considerations for balancing diagnostic benefits with potential risks.
DETAILS: This narrative review synthesizes published evidence on the clinical safety of GBCAs, including acute hypersensitivity reactions, nephrotoxicity, NSF, gadolinium retention, and emerging concepts such as gadolinium-associated symptoms. The authors discuss differences between linear and macrocyclic GBCAs, proposed mechanisms of tissue deposition and fibrosis, the role of kidney dysfunction in gadolinium elimination, current American College of Radiology (ACR) recommendations, and unresolved questions regarding long-term toxicity. Experimental and clinical data addressing tissue retention, dialysis, and mechanistic pathways underlying gadolinium-induced injury are also reviewed. The review highlights that the incidence of NSF has declined substantially following the adoption of risk-based prescribing practices and updated clinical guidelines. Nevertheless, available evidence indicates that gadolinium retention can occur in multiple tissues, including the brain, even in individuals without severe renal impairment. The authors emphasize that tissue retention and toxicity are not fully explained by current GBCA classifications and that macrocyclic agents, although generally considered more stable, do not completely eliminate potential risk. Evidence reviewed also suggests that gadolinium may contribute to acute kidney injury, persistent tissue deposition, rare cases of encephalopathy, and symptoms associated with gadolinium exposure. Current data do not establish a definitive exposure threshold for toxicity, and the benefit of prophylactic hemodialysis after GBCA administration remains uncertain. While observational studies have estimated the risk of NSF with group II agents to be below 0.07%, the review notes that the true absolute risk remains difficult to define because of limitations in available evidence and confounding factors.
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Optical Coherence Tomography Enables Optical Biopsy of Endometrial Tissue for Early Cancer Detection
Catheter-based 3D optical coherence tomography demonstrated high accuracy for distinguishing benign endometrium from endometrial intraepithelial neoplasia and endometrial cancer in this ex vivo study. The findings support its potential as a rapid, minimally invasive optical biopsy technique, although prospective in vivo validation is needed before clinical implementation.
KEY FINDINGS: This proof-of-concept study demonstrates that catheter-based 3D OCT, integrated with quantitative functional, structural, and radiomic image analysis, can differentiate normal and benign endometrium from EIN and endometrial cancer with high diagnostic performance in ex vivo specimens. The ability to image the entire endometrial cavity within minutes and provide automated tissue characterization supports the potential of OCT as a minimally invasive optical biopsy technique. Further prospective in vivo clinical studies are required to validate its diagnostic accuracy and facilitate translation into routine gynecologic practice.
BACKGROUND: Early diagnosis of endometrial cancer (EC) is essential for improving outcomes and preserving fertility in selected patients with endometrial intraepithelial neoplasia (EIN). Current diagnostic approaches rely on invasive endometrial biopsy, which has an estimated 10% false-negative rate and may be limited by sampling variability. Although hysteroscopy permits direct visualization of the uterine cavity, it does not provide subsurface tissue characterization. This study evaluated whether catheter-based three-dimensional (3D) optical coherence tomography (OCT), combined with functional, structural, and radiomic feature analysis, could serve as a noninvasive optical biopsy technique for detecting EIN and EC.
DETAILS: This ex vivo imaging study enrolled patients undergoing hysterectomy at Barnes-Jewish Hospital between December 2024 and June 2025. Of 69 uterine specimens initially imaged, 57 were included in the final analysis after exclusion of the first 12 cases used for workflow optimization. The cohort comprised 16 premenopausal and 41 postmenopausal women, including 23 grade 1 EC, 6 grade 2 EC, 5 EIN, 1 hyperplasia without atypia, 7 cystic atrophy with benign polyps, and 15 normal specimens. A custom 3.1-mm catheter-based OCT system generated volumetric 3D images of the endometrial cavity within 3–5 minutes. Functional, structural, and radiomic features were extracted from OCT images, with 26 statistically significant imaging features selected to construct a cosine similarity matrix and network graph. A leave-one-out cross-validated logistic regression classifier was then developed to distinguish normal or benign tissue from EIN or EC. OCT imaging demonstrated distinct architectural differences between benign and malignant endometrial tissues. Compared with normal endometrium and benign hyperplasia, EIN and EC exhibited greater heterogeneity in optical scattering, increased structural entropy, distorted glandular architecture, and reduced tissue homogeneity. The cosine similarity network correctly classified 32 of 34 EIN/EC specimens and 20 of 23 normal or benign specimens, corresponding to an exploratory sensitivity of 94% and specificity of 87%. The logistic regression classifier achieved an area under the receiver operating characteristic curve (AUC) of 0.957, with 91.2% sensitivity and 82.6% specificity using leave-one-out cross-validation. Misclassifications were primarily attributed to focal fundal lesions, mixed benign and malignant pathology, or very thin inactive endometrium.
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Promising Drug Candidates and Emerging Therapeutic Strategies Against Candida auris
Emerging therapies for Candida auris extend beyond conventional antifungal agents and include repurposed drugs, novel antifungal compounds, vaccines, antimicrobial peptides, and nanotechnology-based approaches. While further clinical validation is needed, these strategies may help address the growing challenge of multidrug-resistant C. auris infections.
KEY FINDINGS: This review underscores the expanding pipeline of therapeutic strategies targeting Candida auris, ranging from repurposed medications and next-generation antifungal agents to vaccines, antimicrobial peptides, nanoparticle formulations, and innovative environmental control measures. Although no single therapy has emerged as a definitive solution, compounds such as ibrexafungerp (SCY-078), ATI-2307, and fosmanogepix, together with drug repurposing and bioinspired approaches, represent promising avenues for addressing multidrug-resistant C. auris infections. Continued translational research and clinical evaluation remain essential to establish safe and effective treatment options for this increasingly important fungal pathogen.
BACKGROUND: Candida auris has rapidly emerged as a multidrug-resistant fungal pathogen of global concern since its first identification in 2009. The organism is associated with healthcare-associated outbreaks, high transmissibility, frequent misidentification, and severe invasive infections, with reported mortality rates ranging from 35% to 72%. Resistance to currently available antifungal agents further complicates treatment, with approximately 90% of isolates resistant to fluconazole, around 30% resistant to amphotericin B, and fewer than 5% resistant to echinocandins. These challenges have accelerated efforts to identify novel antifungal therapies and alternative treatment strategies.
DETAILS: This publication is a comprehensive narrative review that summarizes advances in antifungal research targeting C. auris over the preceding decade. The authors evaluated emerging therapeutic approaches from a medicinal chemistry perspective, including drug repurposing, combination therapy, novel antifungal agents, natural products, metal-based compounds, nanoparticles, vaccines, antimicrobial peptides, and environmental decontamination strategies. The review also examined chemical and physicochemical characteristics of promising compounds, including lipophilicity and topological polar surface area, to identify structural features that may facilitate future antifungal drug development. The review highlights several promising therapeutic candidates with activity against multidrug-resistant C. auris. Drug repurposing identified multiple agents with antifungal or antibiofilm activity, including sertraline, miltefosine, iodoquinol, octenidine dihydrochloride, taurolidine, and bensulfuron methyl. Miltefosine demonstrated fungicidal and antibiofilm activity, while encapsulation within alginate nanoparticles reduced toxicity and improved survival in an infected Galleria mellonella model. The NDV-3A vaccine generated cross-reactive antibodies against C. auris and protected neutropenic mice, with additive efficacy when combined with micafungin.
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Among novel antifungal agents, SCY-078 (ibrexafungerp), an orally available 1,3-ß-D-glucan synthesis inhibitor, demonstrated potent activity against C. auris, with an MIC90 of 1 mg/L and MIC50 and MIC90 values of 0.5 µg/mL and 1 µg/mL, respectively, across 100 isolates representing the four major clades. More than 150 strains with diverse resistance profiles were subsequently shown to be uniformly susceptible to SCY-078, and the agent remained active against pan-resistant isolates while also exhibiting antibiofilm activity.
Additional investigational therapies also demonstrated encouraging preclinical activity. The arylamidine T-2307 (ATI-2307) exhibited in vitro MIC values ranging from 0.125 to 4 µg/mL and improved survival while reducing kidney fungal burden in murine infection models following 3 mg/kg once-daily subcutaneous treatment. Other experimental approaches included antimicrobial peptides, ceragenins, fluorinated hydrazone derivatives, and novel chemical scaffolds designed to overcome existing resistance mechanisms.
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Source: Billamboz, M., Fatima, Z., Hameed, S., et al. Promising Drug Candidates and New Strategies for Fighting against the Emerging Superbug Candida auris. Microorganisms. 2021; 9(3): 634. Published: March 18, 2021. DOI: 10.3390/microorganisms9030634.
Ensitrelvir for Covid-19 Postexposure Prophylaxis in Household Contacts
Early initiation of a 5-day oral ensitrelvir regimen within 72 hours after symptom onset in an index patient significantly reduced the risk of developing Covid-19 among household contacts while maintaining a safety profile comparable to placebo. Clinical benefit was observed across major patient subgroups, including individuals at increased risk for severe disease, and treatment was associated with reduced household transmission. These findings support ensitrelvir as an effective postexposure prophylactic option for household contacts and suggest potential utility in other high-risk exposure settings where rapid outbreak control is needed.
KEY FINDINGS: Early initiation of a 5-day oral ensitrelvir regimen within 72 hours after symptom onset in an index patient significantly reduced the risk of developing Covid-19 among household contacts while maintaining a safety profile comparable to placebo. Clinical benefit was observed across major patient subgroups, including individuals at increased risk for severe disease, and treatment was associated with reduced household transmission. These findings support ensitrelvir as an effective postexposure prophylactic option for household contacts and suggest potential utility in other high-risk exposure settings where rapid outbreak control is needed.
BACKGROUND: Household transmission remains a major contributor to the spread of SARS-CoV-2, particularly among individuals at increased risk for severe Covid-19. Although vaccination and prior infection have reduced disease severity, waning immunity and emerging variants continue to sustain transmission. Previous trials evaluating oral antiviral agents for postexposure prophylaxis in household contacts have not demonstrated significant protection, highlighting the need for effective preventive therapies. This phase 3 trial evaluated whether oral ensitrelvir, a SARS-CoV-2 3C-like protease inhibitor, could prevent Covid-19 among household contacts exposed to an infected index patient.
DETAILS: This phase 3, double-blind, randomized, placebo-controlled trial was conducted between June 2023 and mid-September 2024 across the United States, Argentina, Japan, South Africa, and Vietnam. Eligible household contacts were 12 years of age or older, had a negative SARS-CoV-2 test at enrollment, and were randomized within 72 hours after symptom onset in the index patient. Participants received either ensitrelvir 375 mg on day 1 followed by 125 mg once daily on days 2-5 or matching placebo. The primary endpoint was laboratory-confirmed Covid-19 by day 10 in the modified intention-to-treat population, defined as RT-PCR positivity accompanied by at least one prespecified Covid-19 symptom lasting 48 hours or longer. Secondary endpoints included laboratory-confirmed SARS-CoV-2 infection regardless of symptoms, subgroup analyses, and safety outcomes. Overall, 2,387 household contacts were randomized, including 1,030 participants in the ensitrelvir group and 1,011 in the placebo group within the modified intention-to-treat population. The mean participant age was 42.4 years, 71.1% were enrolled within 48 hours after symptom onset in the index patient, and 37.0% had at least one risk factor for severe Covid-19. By day 10, laboratory-confirmed Covid-19 occurred in 2.9% of participants receiving ensitrelvir compared with 9.0% receiving placebo, corresponding to a risk ratio of 0.33 (95% CI, 0.22-0.49; P<0.001) and an approximate 67% relative risk reduction in the modified intention-to-treat population. In the intention-to-treat population, Covid-19 developed in 4.4% and 10.2% of participants, respectively (risk ratio, 0.43; 95% CI, 0.32-0.59; P<0.001). Laboratory-confirmed SARS-CoV-2 infection irrespective of symptoms was also lower with ensitrelvir (14.0% vs. 21.5%; risk ratio, 0.66; 95% CI, 0.55-0.79). Subgroup analyses demonstrated generally consistent efficacy across age groups and participants with risk factors for severe disease. Among participants with risk factors, Covid-19 developed in 2.4% of the ensitrelvir group compared with 9.9% of the placebo group. Ensitrelvir was also associated with a 34% relative reduction in household SARS-CoV-2 transmission. Adverse events occurred at similar frequencies in the ensitrelvir and placebo groups (15.1% vs. 15.5%), with serious adverse events reported in 0.2% of participants in each group. No Covid-19-related hospitalizations or deaths occurred. Transient reductions in high-density lipoprotein concentrations were observed with ensitrelvir but returned toward baseline by day 15 and were not associated with clinical events.
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