Happy New Year! We hope that the start of 2024 was relaxed and enjoyable for you - but before you get completely back in the swing, we have one more holiday event to offer. To get caught up on the news of the past few weeks, consistent with our still short attention spans, this issue will be a buffet of Quick Hits, organized by topic.
Eat up.
Genetic and Genomics
The FDA has approved the first genetic test for possible increased propensity to develop opioid use disorder. The prescription-only test is intended to be used before a patient receives oral opioids for the first time.
A study of 5,676 (American, mostly white) adults found that nearly 20% of people over age 50 may have at least one organ that’s aging more quickly than the rest of their bodies, which increases their overall risk of death by 20 - 50%. The research, published in Nature, came to these conclusions by using machine learning models to analyze organ-specific proteins and their genes.
Whole-genome sequencing of Pap smears may someday be useful in detecting high-grade ovarian cancer in its early stages. A small, retrospective proof-of-concept study showed that copy number profile abnormality (CPA) scores in DNA obtained from the smears could be used as a measure of genetic instability - and patients with a high level of such instability were more likely to have eventually developed ovarian cancer.
Technology
A device that allows health care workers to obtain a capillary blood sample via fingerstick received FDA 510(k) approval last month. While similar devices are already on the market, this one allows blood to be drawn in “ancillary healthcare facilities” such as local pharmacies, not just in standalone labs - an innovation intended to increase health equity.
Researchers in Nairobi, Kenya, trained an off-the-shelf neural network to distinguish the passive coughs of people with tuberculosis (TB) from those of folks with other lower-respiratory illnesses. The system had a sensitivity of 70% overall; it did best when it used smartphone recordings of people with higher bacterial load or with lung cavities. After COVID, TB is the most common cause of death worldwide due to infectious disease, and can be tough to diagnose in places without access to molecular tests.
Policy
According to a research letter in JAMA Oncology, after the 2021 21st Century Cures Act mandated immediate posting of all medical test results to online portals, the percentage of patients at one medical center in Texas who reviewed their results before their physicians did nearly doubled (from 38% to 75%). Concerns that early access to test results causes patient anxiety have led California and Kentucky to pass legislation to delay electronic release of test results.
Last month, as STAT News reported, HHS’s health technology regulators published final rules requiring “software vendors to disclose how artificial intelligence tools are trained, developed, and tested.” Enforcement of these rules will begin in 2025. Comment: We continue to expect the vast majority of the initial applications of AI to be in the diagnostic field.
COVID
The dominant SARS-CoV-2 variant worldwide and in the US is now the highly mutated JN.1, a daughter of the Omicron variant BA.2. The WHO has not given it a new name - it is called a “Variant of Interest” - and despite its fast growth, it has not resulted in an increased death rate.
According to a recent study published in JAMA Network Open, taking one nasal swab and one throat swab at home and then testing each swab with its own test cartridge increases the sensitivity of at-home COVID tests by 15.5 percentage points (P <0.001). Testing a self-collected nasal swab alone resulted in a sensitivity of 60%, while testing a self-collected throat swab alone gave a sensitivity of 58%.
Folks in Houston can sign up to receive a text if wastewater testing detects COVID, flu, or respiratory syncytial virus (RSV) at their child’s school. The wastewater testing program is a partnership between the Houston Health Department, Rice University, and Houston Public Works.
A 22-week study in one Wisconsin school district showed that air sampling was just as effective at monitoring both COVID and influenza A activity in schools as three other methodologies: school-based rapid antigen testing, PCR testing with home-collected samples, and monitoring the cause of student absenteeism.
The federal Home Test to Treat program, originally available only in certain locations, is now available nationwide to anyone “uninsured or underinsured adult (18+), on Medicare, Medicaid, in the VA healthcare system, or [receiving] care from the Indian Health Services.” The program provides free at-home COVID and flu tests as well as telehealth visits; high-risk folks can have tests and then treatment, if needed, mailed to them. Comment: Great concept, but we wonder if the time lags required by tests and treatments being mailed lessens its effectiveness.
COVID Diagnostics: FDA Update
The FDA issued two new 510(k) premarket notifications, two new EUAs, three amendments to existing EUAs, and no new revocations in December 2023.
510(k) Premarket Notifications: 2
Molecular (1): Roche Cobas Sars-Cov-2 Nucleic Acid Test For Use On The Cobas Liat System
Antigen (1): Quidel Sofia 2 Sars Antigen+ Fia; Sofia 2 Sars Antigen+ Fia Control Swab Set
New EUAs (2):
Molecular (2): RCA Laboratory Services (GENETWORx) Gx HTIQ SARS-CoV-2 Test | RCA Laboratory Services (GENETWORx) Gx HTKB SARS-CoV-2 Test
Amendments to Existing EUAs (3):
COVID Antigen: 2
Flu / RSV Panels: 1
Revocations: 0