About diagnostics
Grail launches long-awaited Galleri blood test, its groundbreaking multi-cancer screening diagnostic: “Designed to trace back the original organ location of as many as 50 different cancers by decoding fragments of tumor DNA found in the bloodstream, Galleri could be Illumina's ticket to a deep foothold in the clinical testing market. The company has estimated the test could help screen as many as 50 million people after its initial debut, before Grail pursues a full FDA approval in 2023.”
Oxford spinout spies the hidden mechanics of DNA and disease with single-pair resolution method: “Nucleome Therapeutics is working on a method known as micro-capture-C, or MCC, to provide a three-dimensional view of the famously twisting double-helix structure, with the ability to zoom in on individual base pairs…
Its latest work on 3D genome mapping was published this week in Nature.”
About health insurance
UnitedHealthcare delays ER coverage policy amid provider backlash: “Amid significant backlash from providers, UnitedHealthcare is delaying its new emergency department coverage policy, which would allow the insurer to retroactively deny ED claims it determines are nonemergent.”
Social Determinants of Health [SDoH] Geographic Variation in Medicare per Beneficiary Spending: “In this cross-sectional study, SDoH were associated with 37.7% of variation in price-adjusted Medicare per beneficiary spending between counties in the highest and lowest quintiles of spending in 2017, including both direct contributions and indirect contributions through other factors. SDoH’s direct contribution accounted for 5.8% of the variation after controlling for patient demographic characteristics, clinical risk, and supply of health care resources.
These findings suggest that addressing SDoH is important for reducing geographic spending variation and improving the value of health care.”
About healthcare IT
Amazon Care has inked deals with multiple companies for telehealth services, executive says: “Amazon has signed on multiple employers to its healthcare service, called Amazon Care, as part of the national expansion of its virtual health service benefit…
The service offers virtual visits, in-person primary care visits at patients' homes or offices and prescription delivery. The on-demand healthcare service enables employees to connect with medical professionals via chat or video conference, typically in less than 60 seconds, and eliminates lengthy wait and travel times to get medical attention, according to Amazon executives…
The service also can deliver medications to users within 120 minutes…”
Meet the ransomware gang behind 235 attacks on US hospitals: 7 things to know: A good summary of this growing problem.
About Covid-19
Coronavirus deaths this year surpass 2020 total: “The coronavirus pandemic has already killed more people this year than in all of 2020, according to a Wall Street Journal analysis of data collected by Johns Hopkins University.
The newspaper found that about 1.883 million people have died from the virus in 2021, compared with 1.88 million last year.”
FDA accuses company of distributing unapproved Covid test and using falsified data: “The Food and Drug Administration announced a recall Thursday of a coronavirus rapid antigen test, accusing the company that makes the tests of distributing them without regulatory approval and using falsified data that inflates their performance.
The agency announced a ‘Class 1 recall’ — its most serious type, indicating that use of the tests may cause serious injuries or death — and fired off a warning letter to Innova Medical Group of Pasadena, Calif., saying an FDA investigation revealed serious problems in the company’s data, but also in its making unapproved rapid tests available to consumers in the United States.”
Chinese researchers find batch of new coronaviruses in bats: “According to the researchers, their discoveries in a single, small region of Yunnan province, southwestern China show just how many coronaviruses there are in bats and how many have the potential to spread to people…
‘In total, we assembled 24 novel coronavirus genomes from different bat species, including four SARS-CoV-2 like coronaviruses,’ the researchers wrote in a report published in the journal Cell.”
Community-level evidence for SARS-CoV-2 vaccine protection of unvaccinated individuals: ”On average, for each 20 percentage points of individuals who are vaccinated in a given population, the positive test fraction for the unvaccinated population decreased approximately twofold. These results provide observational evidence that vaccination not only protects individuals who have been vaccinated but also provides cross-protection to unvaccinated individuals in the community.”
The F.D.A. tells Johnson & Johnson that about 60 million doses made at troubled plant cannot be used: “Federal regulators have told Johnson & Johnson that about 60 million doses of its coronavirus vaccine produced at a troubled Baltimore factory cannot be used because of possible contamination, according to people familiar with the situation.”
About pharma
Third member of U.S. FDA advisory panel resigns over Alzheimer’s drug approval: “Aaron Kesselheim, a Professor of Medicine at Harvard Medical School who had served on the FDA’s advisory committee for nervous system drugs since 2015, told Reuters on Thursday he was stepping down from the panel.
’My rationale was that the FDA needs to re-evaluate how it solicits and uses the advisory committees ... because I didn’t think that the firm recommendations from the committee in this case ... were appropriately integrated into the decision-making process,’ Kesselheim said in an email…
On Tuesday, a member of the advisory group who voted against the approval, Washington University neurologist Dr. Joel Perlmutter, resigned from the committee, citing the FDA's approval of Aduhelm.
Mayo Clinic neurologist Dr. David Knopman said he resigned on Wednesday.”
FDA approves omadacycline for treatment of community-acquired bacterial pneumonia: “Omadacycline (Nuzyra, Paratek Pharmaceuticals) is a novel antibiotic with once-daily oral and IV formulations for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. The once-daily oral-only dose has an initial dose of 300 mg twice on the first day followed by 300 mg once daily for 7 to 14 days, according to the release…
Omadacycline is a modernized tetracycline designed to overcome tetracycline resistance and exhibit activity across a broad spectrum of bacteria, including Gram-positive, Gram-negative and atypicals including other drug-resistant strains, according to the release.” And in two related articles:
WHO reveals new global antibiotic resistance data, more concerns: “The WHO's fourth Global Antimicrobial Resistance and Use Surveillance System (GLASS) Report includes information on more than 3 million laboratory-confirmed bacterial infections caused by pathogens of concern in 70 countries in 2019. That's more than a sixfold increase in the number of infections reported to GLASS when sites first began reporting AMR surveillance data in 2017.
Although WHO officials caution that the data are limited and more research is required to draw firm conclusions, among the findings are high rates of resistance in common pathogens to first-line antibiotics used to treat urinary tract infections (UTIs) and extremely high resistance to last-resort antibiotics in some healthcare-associated pathogens.”
Making drug-resistant bacteria susceptible to antibiotics: “When exposed to antibiotics, some bacteria switch to a dormant state to survive in a process that’s mediated by the production of the molecule hydrogen sulfide (H2S). The NYU team previously showed that this mechanism is present in a wide variety of bacterial species, including Staphylococcus aureus and Pseudomonas aeruginosa, which have produced many multidrug-resistant strains. Previous studies have shown that genetic disruption of H2S could sensitize these pathogens to antibiotics and to the host immune response.”
Bayer pledges $300M to boost production in world's 'contraceptive capital’: “The company has designs on a €250 million ($303 million) investment for a new production plant in Turku, Finland, which it's pegged to become "one of the most modern" factories in the world thanks to its heavy use of automation and robotics…”
About the public’s health
'Miraculous' mosquito hack cuts dengue by 77%: A novel strategy: “The trial used mosquitoes infected with Wolbachia bacteria…
Wolbachia doesn't harm the mosquito, but it camps out in the same parts of its body that the dengue virus needs to get into.
The bacteria compete for resources and make it much harder for dengue virus to replicate, so the mosquito is less likely to cause an infection when it bites again…
Wolbachia are also spectacularly manipulative and can alter the fertility of their hosts to ensure they are passed on to the next generation of mosquitoes.
It means once Wolbachia has been established, it should stick around for a long time and continue to protect against dengue infection.”
CDC warns about spike in RSV cases across South: “The CDC issued a Health Advisory Network warning to doctors and other health care providers to be on alert for the virus, which can cause pneumonia, especially in very small children and babies.”
About healthcare professionals
The Complexities of Physician Supply and Demand: Projections From 2019 to 2034: From the AAMC: “By 2034, we project:
A shortage of primary care physicians of between 17,800 and 48,000.
A shortage across the non- primary care specialties of between 21,000 and 77,100 physicians.”