Blog

12/11/2023

New Thermo Scientific KingFisher Apex Dx system and Applied Biosystems MagMAX Dx Isolation Kit improve preanalytical workflows for clinical laboratories.

CARLSBAD, Calif.–(BUSINESS WIRE)– Thermo Fisher Scientific Inc., the world leader in serving science, today announced the launch of the Thermo Scientific™ KingFisher™ Apex™ Dx, an automated nucleic acid purification instrument, and Applied Biosystems™ MagMAX™ Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.

Clinical laboratories that perform respiratory testing need to generate the highest quality results. To meet their needs, the high-throughput, versatile KingFisher Apex Dx system enables scientists’ labs to recover quality nucleic acids for sensitive downstream applications with maximum consistency, reproducibility, and reliability. The system is designed to be a part of a modular sample preparation to real-time PCR analysis workflow* providing precise results, accurate data management, and robust security features that meet cybersecurity and diagnostic regulatory standards. Additionally, the MagMAX Dx Viral/Pathogen NA Isolation kit offers advanced formulation to ensure reproducible results and is automation compatible with the KingFisher Apex Dx.

“The KingFisher Apex Dx system builds on decades of product expertise and innovation customers have come to trust in our KingFisher instrument line,” said Ellie Mahjubi, vice president and general manager, sample preparation at Thermo Fisher Scientific. “The combination of the Apex Dx system and the MagMAX Dx Viral/Pathogen NA Isolation Kit further simplifies sample preparation for clinical labs so they can have confidence in downstream results when testing for respiratory diseases.”

The KingFisher Apex Dx system automates the extraction of up to 24 or 96 DNA, RNA, protein, or cell samples and transitions from clinical research to diagnostics by offering research use only (RUO) and IVD software modes. It can be integrated with a Laboratory Information Management System (LIMS) or Laboratory Information System (LIS) via Diomni Enterprise Software for enhanced data management and workflow optimization.

The MagMAX Dx Viral/Pathogen NA Isolation Kit offers a new advanced formulation to maximize nucleic acid yield from routinely tested respiratory pathogens such as S. aureus, M. tuberculosis, influenza, RSV, and SARS-CoV-2. This kit also helps laboratories meet greener policies with REACH-compliant components and responsibly sourced packaging.

For more information including technical specifications, applications, and consumables, please visit www.thermofisher.com/kingfisherapex and MagMAX Dx Viral/Pathogen Nucleic Acid Isolation Kit. The MagMAX Dx Viral/Pathogen NA Isolation Kit is currently available in North America and coming soon to other regions.

*Enable in Diomni Integrated mode with QuantStudio 5 and 7 Pro Dx Instruments

For In Vitro Diagnostic Use. Regulatory requirements vary by country. Product may not be available in your geographic region.

Thermo Fisher Scientific Introduces New Sample Preparation Solutions to Simplify and Automate Respiratory Diagnostic Testing | Newsroom | Thermo Fisher Scientific

Laura Dyrda and Naomi Diaz 

Hospitals in at least four states across across the South and Midwest experienced disruptions Nov. 24 due to potential cybersecurity incidents, although there is no evidence officially linking the incidences.

On Thanksgiving Day, UT Health East Texas in Tyler told CNN its hospitals reverted to downtime procedures after a security incident forced computer systems offline. The 10-hospital system locked down its network after network outage, according to the report. During the downtime, the hospital diverted ambulances to other ERs.

BSA Health System in Amarillo, Texas, also reported an outage and diverted ambulances after a “potential security incident,” according to a report from ABC affiliate KVII. A hospital spokesperson told the news outlet BSA experienced the outage Nov. 24 and reverted to paper records.

The University of Kansas Health System St. Francis Campus in Topeka also went on ER diversion after a network outage Nov. 24. The health system noted a “potential security incident” led to the outage and the hospital practiced standard downtime protocols, according to news station WIBW.

Tulsa, Okla.-based Hillcrest HealthCare System discovered a potential security incident Nov. 24 as well and told the Tulsa World the issue affected access to patient charts. The health system diverted some ER patients as a precaution but told the publication patient care has not been negatively affected.

Vanderbilt University Medical Center in Nashville, Tenn., identified a cybersecurity incident Nov. 24 that compromised a database, according to The Record. The health system said the database did not contain personal or protected information. Ransomware gang Meow added VUMC to its “leak site,” indicating information was leaked on the dark web.

Lovelace Health System in Albuquerque, N.M., is experiencing a network outage that is affecting its emergency care and told KOAT Action News that local EMS are rerouting patients requiring emergency care to alternative facilities. The health system also said it is in the process of rescheduling certain non-urgent elective surgeries while it works to restore its systems.

Multiple hospitals report IT disruptions on Thanksgiving (beckershospitalreview.com)

Giles Bruce

Amazon Prime members can now get healthcare for an extra $9 a month.

The tech giant launched One Medical for Prime on Nov. 8, hoping to capitalize on its nearly $4 billion acquisition of the membership-based primary care company earlier this year.

The new service offers One Medical subscriptions to Prime members at a discounted rate, giving them unlimited 24/7 virtual visits and online scheduling for same- or next-day appointments at One Medical’s more than 200 brick-and-mortar clinics.

“When it is easier for people to get the care they need, they engage more in their health, and realize better health outcomes,” said Neil Lindsay, senior vice president of Amazon Health, in a Nov. 8 blog post. “That’s why we are bringing One Medical’s exceptional experience to Prime members — it’s healthcare that makes it dramatically easier to get and stay healthy.”

The new service marks the tech giant’s latest entry into healthcare following this year’s nationwide rollout of the Amazon Clinic telehealth platform and introduction of RxPass, which offers generic prescriptions to Prime members for $5 a month.

The move also shows Amazon’s willingness to integrate its new healthcare offerings into its existing services. Amazon Prime’s estimated 200 million members already pay $14.99 a month (or $139 annually) for free, speedy deliveries of everything from toothpaste to pillowcases — now they can add healthcare for an extra $9 monthly (or $99 for the whole year). The One Medical memberships typically run $199 per year.

“This new benefit is the latest example of how we’re making it easier for Prime members to take care of their health,” said Jamil Ghani, vice president of Amazon Prime, in the blog post.

One Medical for Prime members can access the on-demand virtual visits at no extra cost through the One Medical app, including messaging-based care for common conditions such as seasonal allergies or cold sores (via the Treat Me Now feature), or urgent video chats for issues like minor injuries or high fevers.

The virtual visits are staffed by One Medical primary care providers, of which the company has “thousands,” a spokesperson told Becker’s. In-person and scheduled remote appointments are not included in the membership and are billed to insurance or the patient via self-pay.

Like other healthcare disruptors, One Medical also continues to grow its hospital partnerships. The concierge primary care company has specialty care referral agreements with health systems in its nearly 20 local markets.

Amazon launches One Medical for Prime (beckershospitalreview.com)

Paige Twenter

Since mid-September, drugmakers have reported five new drug shortages, including medications for lung cancer, hypertension and eye infections. 

The scope of cancer drug shortages has slightly eased since spring, but with the latest addition, at least 15 chemotherapies are currently in short supply. 

Here are drug shortages recently reported by the FDA and the American Society of Health-System Pharmacists.

Editor’s note: The drugs are listed in alphabetical order. 

1. Betaxolol tablets: After KVK-Tech recalled one lot of betaxolol tablets because one oxycodone pill was found on the packaging line after a batch was packaged, the drugmaker is reporting a shortage of 10 milligram and 20 milligram tablets. The therapy is used to treat hypertension. KVK-Tech could not predict a resupply date for the former solutions but said the latter should be available in normal levels in early October.

2. Nitroglycerin injectable: American Regent and Baxter Healthcare have four solutions in shortage because of high demand for the hypertension drug. American Regent said it expects the supply issue of 5 milligram per 1 milliliter to resolve in January, and Baxter has 10, 20 and 40 milligram per 1 milliliter solutions on allocation until late November. 

3. Sulfacetamide sodium and prednisolone sodium phosphate ophthalmic solution: Bausch Health, the only supplier of this eye drop used to treat infections and swelling, has 10% per 0.23% ophthalmic solution in 5 milliliter bottles on back order without a release date. 

4. Topotecan capsules: The small cell lung cancer treatment is in short supply as Sandoz put its 0.25 milligram and 1 milligram solutions on back order. The company said supply levels should rebound in November. No other presentations are available. 

5. Trimethobenzamide injection: Par Pharmaceuticals, the sole supplier of this anti-nausea medicine, has its 100 milligram per milliliter, 2 milliliter vials on back order because of high demand. The drugmaker said it will release supply as it becomes available.

5 drugs now in shortage (beckershospitalreview.com)

Molly Gamble

Hospital margins are moving in the right direction, as the median year-to-date operating margin improved in August to 1.1 percent, according to Kaufman Hall.

August’s median of 1.1 percent marked an upswing from the 0.9 percent median margin recorded in July, according to Kaufman Hall’s latest “National Hospital Flash Report” — based on data from more than 1,300 hospitals.

Increased revenue offset hospitals’ increased supply and drug expenses in August. Decreased reliance on contract labor helped labor expenses decline on a volume-adjusted basis, while average lengths of stay also fell, by 4 percent month over month.

Although hospital margins sit below historical levels, 2023 has brought less variance as positive margins are becoming more frequent. This nonlinear recovery follows hospitals’ worst financial year since the COVID-19 pandemic. Erik Swanson, senior vice president of data and analytics with Kaufman Hall, said it is important for hospitals to look ahead in the current moment. 

“This period of relative stabilization is the time for hospitals to re-engage in capital planning efforts,” Mr. Swanson said. “Hospitals may be feeling reluctant given the last few years, but those that wait may find themselves falling behind their competitors and missing out on key opportunities.”

Hospital margins inch up to 1.1% in August (beckershospitalreview.com)

Molly Gamble 

More than 250 hospitals and health systems are urging Congress to halt the $8 billion reduction to Medicaid disproportionate share hospital funding, set to begin Oct. 1.

The funding cuts, part of the Affordable Care Act, will curb Medicaid DSH funding by $8 billion in fiscal years 2024 through 2027 — a $32 billion reduction total. In their Sept. 14 appeal to Congress, safety-net hospitals urged lawmakers to “eliminate, at a minimum” the $16 billion in cuts scheduled for fiscal years 2024 and 2025. 

The Medicaid DSH program, established in the 1980s, provides financial support to hospitals that serve a significantly disproportionate number of low-income patients and the under- and uninsured.

“The need for DSH funding is even greater now, as hospital expenses per patient have increased significantly since the pandemic,” the hospitals, represented by the association America’s Essential Hospitals, wrote to Congress. They said ongoing high levels of uncompensated care nationwide make Medicaid DSH cuts indefensible.

The American Hospital Association has noted, in separate communication, that the scheduled cuts would coincide with a “difficult transition” for the Medicaid program, as states are reviewing eligibility and disenrolling people who no longer qualify for Medicaid after the COVID-19 public health emergency ended in May. 

The ACA included Medicaid DSH cuts under the reasoning that hospitals would care for fewer uninsured patients as health insurance coverage expanded. Congress has previously staved off the cuts 11 times, in bipartisan fashion. 

Hospitals’ appeal comes as Congress hurries to wrap up its appropriations process and pass a funding bill by Sept. 30. Inability to pass a funding bill could result in a partial or complete shutdown of the federal agency and services and risk programs due to end at the end of the fiscal year without Congressional action. The House of Representatives is preparing for a Republican-led continuing resolution — a stopgap bill that would extend the funding deadline by one month — that is unlikely to proceed in the Democrat-controlled Senate. 

Hospitals urge Congress to scrap $8B in cuts as shutdown looms (beckershospitalreview.com)

Noah Schwartz 

San Antonio-based Methodist Healthcare System invested $75 million to reopen a shuttered San Antonio hospital before the end of the month, San Antonio Business Journal reported Sept. 18.

The hospital, formerly known as Forest Park Medical Center, has been closed since 2015. The COVID-19 pandemic delayed Methodist’s construction and reopening plans. 

After redevelopment, the new Methodist Hospital Landmark location will have 54 beds, 12 operating rooms and 27 private patient rooms. 

“All of the Methodist Healthcare hospitals are dealing with capacity challenges due to growth in the market and demand for our services,” Methodist Hospital Landmark CEO Ryan Simpson told the Journal. “This facility allows us to have more capacity as a system. It happens to be in a growing part of the city.”

Paige Twenter 

While some hospitals are paying five to 10 times more for cancer drugs during a monthslong shortage, the U.S. saw 14 new drug supply issues since early August. 

Here are 14 new drug shortages, according to data from the FDA and the American Society of Health-System Pharmacists. 

Editor’s note: The drugs are listed in alphabetical order.

1. Alfuzosin extended-release tablets: Three solutions are unavailable and two are available, and the shortage is predicted to recover in August. The drug relaxes a patient’s bladder and prostate muscles. 

2. Atropine sulfate ophthalmic ointment: Bausch Health is reporting a short-term shortage of the medication that’s used to dilate the pupil before eye exams. The company is the sole supplier of the solution and did not share an estimated release date. 

3. Azacitidine injections: Three drugmakers stopped making 100 milligram solutions of the leukemia drug. 

4. Collagenase ointments: There is not enough supply for usual ordering of the ointment that’s used to treat burned skin and skin ulcers as Smith & Nephew has two solutions on intermittent back order without a release date.

5. Glipizide XL tablets: Pfizer discontinued manufacturing the Type 2 diabetes drug. 

6. Ibuprofen and famotidine tablets: Teva Pharmaceuticals and Horizon Therapeutics discontinued manufacturing the painkiller. 

7. Iobenguane I-131 injections: Progenics Pharmaceuticals stopped making two solutions because of low demand for the oncology medication. 

8. Iodine and potassium iodide topical solutions: Two solutions of the dermatology drug are in shortage and one solution is available. Cooper Surgical could not estimate a resupply date, and Gordon Laboratories predicted mid-September. 

9. Nitroglycerin injections: One solution of the hypertension drug is available as three others are in limited supply without a release date. 

10. Nystatin topical powder: Padagis has two solutions of the antifungal medication on allocation through October and one on intermittent back order. No other solutions are available. 

11. Pamidronate disodium injections: Five solutions of the drug that treats bone fragility are in shortage. Viatris said it expects two products to return to normal supply levels in September, and Pfizer predicted resupply between October and January for its three solutions. 

12. Piroxicam capsules: Pfizer said it is discontinuing production of the painkiller. Supply of the 20 milligram solutions is expected to last until October. 

13. Tedizolid injections: As operations wind down at Nabriva Therapeutics and transition to Merck, there’s insufficient supply of the bacterial skin infection drug. Resupply is expected in late August.

14. Theophylline 24-hour extended-release capsules and tablets: Six solutions of the lung disease medication are on back order and two are available. Rhodes Pharmaceuticals could not forecast a resupply date for two of its solutions, and Endo Pharmaceuticals predicted its shortage to end in October. 

14 drugs now in shortage (beckershospitalreview.com)

Giles Bruce 

Hospitals and physicians are paying millions of dollars for a hidden fee to receive reimbursement from payers electronically, ProPublica reported Aug. 15.

Payers and middlemen charge healthcare providers as much as 5 percent to process electronic payments, according to the story. The ACA required payers to offer electronic funds transfers and nudged physicians to take them. CMS at one time prohibited the processing fees before reversing course.

Tim Reiner, senior vice president of revenue management of Altamonte Springs, Fla.-based AdventHealth, complained to CMS about the fees in 2020, the news outlet reported. “I have to pay $1.8M in expenses that I could use on PPE for our employees, or setting up testing sites, or providing charity care, or covering other community benefits,” he wrote.

“It’s ridiculous,” Karen Jackson, a retired senior CMS official, told the news outlet.

The U.S. Department of Veterans of Affairs has declined to pay the fees, declaring them illegal, according to the story.

The pushback against the fees has been led by Alex Shteynshlyuger, MD, a private urologist in New York City, while the campaign to keep them has been spearheaded by Matthew Albright, chief lobbyist at payment processing company Zelis, according to the article. Mr. Albright, a former CMS official, had pressed CMS on getting rid of its ban on the fees. The agency told ProPublica it had no legal authority to outlaw the fees, adding that it “receives feedback from a wide range of stakeholders on an ongoing basis.”

Other electronic payment vendors include UnitedHealth Group subsidiaries Change Healthcare and VPay. UnitedHealth told ProPublica the companies cut down on administrative burden and speed up payments for providers. Zelis told the news outlet that it helps prevent “many of the obstacles that keep providers from efficiently initiating, receiving, and benefitting from electronic payments.”

‘It’s ridiculous’: Why hospitals pay millions to get paid electronically (beckershospitalreview.com)

July 24, 2023 – Pfizer announced immediate efforts to provide relief and repair the damage caused to its manufacturing facility in Rocky Mount, North Carolina after a violent tornado swept through the town on Wednesday, July 19. All 3,200 local Pfizer colleagues reporting to this manufacturing site are safe and accounted for after excellent implementation of the site’s long-standing evacuation plan. Crews are working around-the-clock to restore power, assess the structural integrity of the building and move finished medicines to nearby sites for storage. 

Pfizer also announced a donation to the American Red Cross North Carolina Chapter and United Way Tar River Region to support the relief and recovery needs. Additionally, the Pfizer Foundation will match employee donations to these organizations. 

The site is closed while the damage is assessed. Pfizer is committed to rapidly restoring full function to the site, which plays a critical role in the U.S. healthcare system. This effort is in close partnership with the U.S. Food and Drug Administration Commissioner Robert Califf, North Carolina Governor Roy Cooper as well as other state, local and federal officials. 

Most of the damage was caused to the warehouse facility, which stores raw materials, packaging supplies, and finished medicines awaiting release by quality assurance. Pfizer is working diligently to move product to other nearby sites for storage and to identify sources to replace damaged raw materials and supplies. Pfizer is also exploring alternative manufacturing locations for production across our significant manufacturing presence in the U.S. and internationally and across the company’s partner network. After an initial assessment, there does not appear to be any major damage to the medicine production areas. 

Since 1968, the Rocky Mount facility has been a key producer for sterile injectables. Currently, it is responsible for manufacturing nearly 25 percent of all Pfizer’s sterile injectables – including anesthesia, analgesia, therapeutics, anti-infectives and neuromuscular blockers – which is nearly 8 percent of all the sterile injectables used in U.S. hospitals. The site is one of 10 Pfizer manufacturing sites located in the United States. 

Learn More 

Pfizer announces post-tornado relief plans for Rocky Mount community and manufacturing facility (repertoiremag.com)