Trends & Technology

The U.S. Food and Drug Administration (FDA) granted marketing authorization to NOWDiagnostics for the First To Know Syphilis Test. This is the first at-home, over-the-counter test to detect Treponema pallidum (syphilis) antibodies in human blood. Results from this type of test alone are not sufficient to diagnose syphilis infection and should be followed by additional testing to confirm a diagnosis of syphilis.

According to the U.S. Centers for Disease Control and Prevention, reported syphilis cases increased 80% in the United States between 2018 and 2022 (from 115,000 to more than 207,000), continuing a decades-long upward trend.

The test provides an at-home result without a prescription, in approximately 15 minutes, which individuals can use to better inform next steps with a health care provider. If left untreated, syphilis can seriously damage the heart and brain and can cause blindness, deafness and paralysis. When transmitted during pregnancy, it can cause miscarriage, lifelong medical issues and infant death.

As noted above, positive test results from this test alone are not sufficient to diagnose syphilis infection and should be followed by additional laboratory testing through a health care provider to confirm a diagnosis of syphilis. Results of this test will be positive for individuals previously diagnosed with syphilis, even if they were successfully treated. Results of the test alone should not be used to start, stop or change any treatments without a health care provider.

Source: asamonitor.pub/4dNvOl0

A commercial artificial intelligence (AI) tool used off-label was effective at excluding pathology and had equal or lower rates of critical misses on chest X-ray than radiologists, according to a study published in Radiology, a journal of the Radiological Society of North America (RSNA).

Recent developments in AI have sparked a growing interest in computer-assisted diagnosis, partly motivated by the increasing workload faced by radiology departments, the global shortage of radiologists and the potential for burnout in the field. Radiology practices have a high volume of unremarkable (no clinically significant findings) chest X-rays, and AI could possibly improve workflow by providing an automatic report.

Researchers in Denmark set out to estimate the proportion of unremarkable chest X-rays where AI could correctly exclude pathology without increasing diagnostic errors. The study included radiology reports and data from 1,961 patients (median age, 72 years; 993 female), with one chest X-ray per patient, obtained from four Danish hospitals.

The research team wanted to know whether the quality of mistakes made by AI and radiologists was different and if AI mistakes, on average, are objectively worse than human mistakes.

The AI tool was adapted to generate a chest X-ray “remarkableness” probability, which was used to calculate specificity (a measure of a medical test's ability to correctly identify people who do not have a disease) at different AI sensitivities.

Two chest radiologists, who were blinded to the AI output, labeled the chest X-rays as “remarkable” or “unremarkable” based on predefined unremarkable findings. Chest X-rays with missed findings by AI and/or the radiology report were graded by one chest radiologist – blinded to whether the mistake was made by AI or radiologist – as critical, clinically significant or clinically insignificant.

The reference standard labeled 1,231 of 1,961 chest X-rays (62.8%) as remarkable and 730 of 1,961 (37.2%) as unremarkable. The AI tool correctly excluded pathology in 24.5%- 52.7% of unremarkable chest X-rays at greater than or equal to 98% sensitivity, with lower rates of critical misses than found in the radiology reports associated with the images.

Source: asamonitor.pub/4dxwfjG

Pfizer Inc. and BioNTech SE announced top-line results from their Phase 3 clinical trial to evaluate the companies' combined mRNA vaccine candidate against influenza and COVID-19 in healthy individuals 18-64 years of age. The combination candidate consists of Pfizer's mRNA-based influenza vaccine candidate with the companies' licensed COVID-19 vaccine. The Phase 3 trial measured two primary immunogenicity objectives (immunogenicity against SARS-CoV-2 as well as immunogenicity against influenza A and B), of which one was met.

In this clinical trial, the vaccine candidate was compared to a licensed influenza vaccine and the companies' licensed COVID-19 vaccine given at the same visit. The primary immunogenicity objectives were to demonstrate that the antibody responses to influenza and to SARS-CoV-2 elicited by the combination vaccine candidate were non-inferior to standard of care. Compared to a licensed influenza vaccine, the Pfizer evaluated trivalent (tIRV) formulation was noteworthy for eliciting robust influenza A responses, including a continued trend of higher influenza A responses versus a licensed influenza vaccine, while it showed lower geometric mean titers and seroconversion against the influenza B strain. In addition, the formulation demonstrated comparable responses against SARS-CoV-2 versus the companies' licensed COVID-19 vaccine. No safety signals with the combination vaccine have been identified in an ongoing safety data review. Participants who received a licensed influenza and COVID-19 vaccine with co-administration continued to elicit robust immune responses against both influenza and COVID-19 with no safety signals identified to date.

In a separate Phase 2 trial, Pfizer evaluated tIRV mRNA standalone vaccine candidates which demonstrated robust immunogenicity in individuals 18-64 years of age. The companies are evaluating adjustments to the combination vaccine candidate aimed at improving immune responses against influenza B and will discuss next steps with health authorities.

Source: asamonitor.pub/46St5Vg

Masimo announced that the Masimo W1^® medical watch has received FDA 510(k) clearance for connectivity, allowing it to be integrated with the Masimo SafetyNet^® comprehensive telemonitoring solution. Masimo W1 Medical received FDA clearance last year as the first medical watch to provide continuous oxygen saturation (SpO2) and pulse rate (PR) for over-the-counter and prescription use at home and in hospitals. The combination of Masimo W1 Medical and Masimo SafetyNet allows patient data, collected via the wrist, to be made available on the Masimo SafetyNet smartphone app and reviewed by remote caregivers, including by hospital clinicians on the web-based Masimo SafetyNet clinician portal.

The clinical significance of Masimo W1 Medical comes from its integrated Masimo MW-1 sensor, hardware, and software module, which incorporates Signal Extraction Technology^® pulse oximetry and rainbow^® Pulse CO-Oximetry knowledge into a single wearable module. It has an integrated optical sensor and electrocardiogram (ECG) electrode pads that can be used to detect physiological signals. The Masimo MW-1 module also processes these signals using Masimo's proprietary signal processing algorithms to output high-resolution SpO2, PR, perfusion index (Pi), and HR from an ECG.

The continuous data from the Masimo MW-1 module is displayed in real time on the Masimo W1 watch touchscreen. With the addition of Bluetooth connectivity, patients can use the Masimo SafetyNet app on their phone to input additional symptoms into CarePrograms designed by their clinicians, view their live data and trends, conduct virtual visits with clinicians, and view educational resources.

In turn, clinicians can examine data and trends and receive customized notifications within the Masimo SafetyNet clinician portal. With Masimo SafetyNet, clinicians can more easily track patient progress, tailor remote care programs to match each patient's needs, and streamline their workflows with high-fidelity reports, rich analytics, and the integration of reliable medical data into electronic medical records (EMRs).

Source: asamonitor.pub/3X7loHn