Early Alzheimer’s Disease Detection Test Gains Key FDA Approval

May 17, 2022 - A new tool is coming to market to improve the early detection of Alzheimer's disease by testing cerebral spinal fluid.

FDA Greenlights First In-Vitro Alzheimer’s Disease Test

FDA recently permitted the marketing of the first in vitro diagnostic test for the early detection of amyloid plaques associated with Alzheimer’s disease. 

Adult patients aged 55 years and older being evaluated for Alzheimer’s disease and other causes of cognitive decline can use the Lumipulse G  β-Amyloid Ratio (1-42/1-40) test. The test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in the human cerebral spinal fluid (CSF).

CFS can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. A positive test result is consistent with the presence of amyloid plaques, while a negative result reduces the likelihood that a patient’s cognitive impairment is due to Alzheimer’s disease.

These results enable physicians to pursue other causes of cognitive decline and dementia, an FDA spokesperson said. And experts may interpret results in conjunction with additional patient clinical information. READ MORE

CDC: Children With Chronic Disease Likelier to Use Telehealth Services

In the second half of 2020, only 14.1 percent of children used telehealth due to the pandemic, but use was higher among those with asthma, a developmental condition, or a disability, the Centers for Disease Control and Prevention (CDC) found.

In total, about 12.6 million children, or 17.5 percent, used telehealth in the past 12 months, which included a period before the coronavirus pandemic. Approximately 10.2 million children, or 14.1 percent, used telehealth due to the COVID-19 pandemic, the data showed.

About 23.5 percent of children with asthma used telehealth because of the pandemic compared with 13.6 percent of those without asthma. Similarly, 32.5 percent and 29.8 percent of children with a current developmental condition and a disability, respectively, used telemedicine due to the pandemic. This was significantly higher than the 11.1 percent of children without a developmental condition and 11.4 without a disability who used telehealth in the same period.

The use of telehealth was the most frequent among children with family incomes below the federal poverty level, at 20.5 percent. Children with parents who had higher than a high school education were also more likely to participate in telehealth, at 18.3 percent, versus those whose parents only had a general equivalency diploma, at 15.4 percent. READ MORE

Microsoft’s Nuance to Launch Collaborative for Healthcare AI

Nuance, a Microsoft company specializing in conversational artificial intelligence (AI), has partnered with peer-learning company The Health Management Academy (The Academy) to launch the AI Collaborative, an experiential community of health systems executives focused on advancing the use and deployment of AI in healthcare.

Health system investment in AI solutions has increased over the years and those behind the AI Collaborative state that this investment necessitates regular touchpoints among health system executives. Members of The Academy, a leadership development community for healthcare executives, have reportedly expressed a desire for dedicated spaces to explore the potential of AI in healthcare.

The AI Collaborative will offer touchpoints to serve as an opportunity for leaders to share questions, challenges, and successes in real time.

These touchpoints will be provided in the form of AI Collaborative Summits, where stakeholders in analytics, clinical transformation, and digital strategy across health system leadership teams will meet with subject-matter experts in med-tech, life sciences, and the payer sectors. Summits will also offer workshops and other learning opportunities centered around AI’s potential as a healthcare tool. READ MORE

AHA: More Financial Need to Bolster Pediatric Workforce

The American Hospital Association (AHA) and 25 other healthcare organizations have asked Congress to increase funding for the Children’s Hospitals Graduate Medical Education (CHGME) program to help support the pediatric workforce.

The FY 2022 Consolidated Appropriations Act included $375 million for the CHGME program, which helped closer align the program funding with other provider training programs. Still, the healthcare organizations stressed that more support is needed. The groups have requested that Congress provide $718.8 million in CHGME funding for fiscal year (FY) 2023.

Current funding for CHGME training programs is only around half of the federal funding that the Medicare GME program receives. For example, funding is $79,813 per pediatric resident compared to $156,128 per resident in the Medicare GME program. Without the increase in financing, the CHGME funding will fall to 46 percent of Medicare GME funding by 2026. READ MORE

Mental Healthcare Needs Among Seniors Continue to Rise

Over the last decade, seniors have experienced rising rates of mental healthcare needs, drug-related deaths, and early mortality, the UnitedHealth Foundation’s 2022 Senior Report shows.

Mental and behavioral health among seniors suffered. Suicide rates rose 13 percent in the last decade. Despite payers’ efforts, almost 9,240 more seniors died from intentional self-harm in the 2018 to 2020 timeframe than in the 2009 to 2011 timeframe.

Depression diagnoses rose nine percent from 2011 to 2020. Frequent mental health distress also grew more rampant. Slightly more than 8 percent of seniors stated that their mental health was not in good condition for 14 or more of the past 30 days in 2020, compared to 7.5 percent in 2011. This represents an 8 percent increase.

The drug-related death rate jumped 147 percent over the past decade for individuals ages 65 to 74 and 100 percent for all seniors 65 years old and older. The rate doubled from 4.2 deaths per 100,000 seniors in the 2008 to 2010 timeframe to 8.4 deaths in 2020. READ MORE

OIG: Adverse Patient Safety Events Impact a Quarter of Medicare Members

One-quarter of Medicare beneficiaries receiving treatment in an acute care hospital in 2018 experienced some sort of adverse patient safety event, a hit to the overall patient experience that also results in higher program costs, according to a recent HHS Office of Inspector General (OIG) report.

This figure represents little improvement from the first time OIG conducted such an audit ten years prior. In 2008, 27 percent of Medicare members receiving treatment in an acute care hospital experienced some sort of patient harm, resulting in $324 million in additional costs for Medicare and patients.

Overall, 25 percent of Medicare members experience some sort of adverse patient safety event, 12 percent of which were considered adverse events, or events that led to longer hospital stays, permanent harm, life-saving intervention, or death. The other 13 percent experienced what the researchers called temporary harm events, or events that required intervention but did not cause lasting harm, prolonged hospital stays, or life-saving treatment.

Most of the harm events (48 percent) were related to medication issues, like patients experiencing delirium or other changes in mental status. Other harm events were linked to patient care, surgical or procedure errors, and infections. READ MORE

Novo Nordisk, Flagship Pioneering Join Forces for Rare Disease Treatments

Novo Nordisk and Flagship Pioneering recently collaborated to create a portfolio of novel research programs to develop transformation metabolic and rare disease treatments.

The companies will apply Flagship’s innovative bioplatforms to scientific challenges in disease areas within cardiometabolic and rare diseases and initiate research programs based on these. Currently, Flagship’s bioplatform is comprised of 41 companies.

Overall, the collaboration will provide extensive access to innovation and leverage the technology platforms of multiple biotech companies to create a portfolio of medicines across several disease areas.

Under the terms of the collaboration, Novo Nordisk will provide funding for initiated research programs and have an exclusive option to license each program. The goal is to initiate three to five research programs within the first three years of the collaboration. Additionally, Flagship’s Pioneering Medicines and the Novo Nordisk Bio-Innovation Hub will jointly select the most promising product concepts and conduct research programs. READ MORE