New York Republicans (slowly) move to endorse Trump

 New York’s congressional Republicans are finally jumping off the 2024 presidential fence.

Rep. Nicole Malliotakis (R-Staten Island) and Rep Nick LaLota (R-Long Island) both told The Post they endorse former President Trump.

“As a Navy Veteran and member of both the Armed Services and Homeland Security Committees, I understand America needs a Commander-in-Chief who will keep us safe,” LaLota said. “President Trump’s policies made our nation stronger and had us on track to prosperity. As our 47th president, he will clean up the mess President Biden created.”

A Malliotakis spokeswoman added that “Nicole supports President Trump and will make a formal endorsement at the appropriate time.”

Four other members of the nine-member Republican delegation have not endorsed any candidate in the 2024 presidential primary — despite former President Trump’s commanding Iowa caucus blowout, and with the New Hampshire primary looming Tuesday.

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Long Island Rep. Nick Lalota came out with a strong endorsement of former President TrumpCQ-Roll Call, Inc via Getty Images

Reps. Mike Lawler (R-Rockland), Brandon Williams (R-Syracuse), Anthony D’Esposito (R-Long Island), and Andrew Garbarino (R-Long Island); along with Nassau County legislator Mazi Pilip, who is running in the special election to replace disgraced Rep. George Santos, have yet to endorse.

In 2022 Lawler publicly expressed his wish for an alternative to Trump — and floated Florida Gov. Ron DeSantis as the right person.

“Long Island has become more red, but It’s not Trump country. I would think they might be a little skittish,” said one plugged-in Republican operative. “Maybe they’re hoping [Trump] gets convicted and kicked off the ballot.”

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Many embattled GOP congressmen in New York have been slow to back former President Trump.Getty Images

New York congressional members who are backing Trump include Rep. Nick Langworthy (R-Chautauqua) and Rep. Claudia Tenney (R-Finger Lakes).

Another upstater, Rep. Elise Stefanik (R-Schuylerville), is so close to the former president she is widely viewed as a potential running mate.

During the 2020 presidential race, Long Island voters were divided, with Nassau voting for Biden, while Trump took Suffolk.

The 2024 landscape does not bode well for Republicans after New York’s highest court gave Democrats another chance to redraw the state’s House districts — something they will almost certainly do in a way that targets vulnerable Republicans.

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GOP members of Congress from New York are top targets for Democrats in 2024.CQ-Roll Call, Inc via Getty Images

All four Trump holdouts are in seats Democrats plan to contest in the 2024 elections.

“I am happy about it,” New York State Democratic chairman Jay Jacobs said of the forthcoming new districts and confirmed that the party would vigorously contest all the GOP fence-sitters. “They’re significant targets because they are in districts that tend to lean moderate,” he noted.

Pro-Trump insiders warned, however, that continued fence-sitting comes with risks.

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Former Rep. George Santos’s resignation in disgrace will also hang over the 2024 election results in Long Island.CQ-Roll Call, Inc via Getty Images

“I know these are tight races, but there is a risk that the Trump base will stay home. If even one or two percent of the Trump base sees this and stays home you’re screwed as well,” said GOP consultant Caroline Wren. “At this point, members who have not endorsed Donald Trump are much more concerned about what the donor class thinks of them, than their actual constituents. And that is a cross they will have to bear”

A raft of retirements, leadership crises, and the expulsion of former Rep. George Santos has left the party with what could be a one-seat majority for 2024.

Empire State Democrats would not even pick off all of them in order to take back the House and enthrone Brooklyn Rep. Hakeem Jeffries as Speaker.

https://nypost.com/2024/01/20/news/new-york-republicans-slowly-move-to-endorse-trump/

Simple Urine Test Could Reveal Early-Stage Lung Cancer

 Lung cancer is the deadliest cancer in the world, largely because so many patients are diagnosed late.

Screening more patients could help, yet screening rates remain critically low. In the United States, only about 6% of eligible people get screened , according to the American Lung Association. Contrast that with screening rates for breast, cervical, and colorectal cancer, which all top 70%.

But what if lung cancer detection was as simple as taking a puff on an inhaler and following up with a urine test?

Researchers at the Massachusetts Institute of Technology (MIT), Cambridge, Massachusetts, have developed nanosensors that target lung cancer proteins and can be delivered via inhaler or nebulizer, according to research published this month in Science Advances. If the sensors spot these proteins, they produce a signal in the urine that can be detected with a paper test strip.

"It's a more complex version of a pregnancy test, but it's very simple to use," said Qian Zhong, PhD, an MIT researcher and co-lead author of the study.

Currently, the only recommended screening test for lung cancer is low-dose CT. But not everyone has easy access to screening facilities, said the other co-lead author Edward Tan, PhD, a former MIT postdoc and currently a scientist at the biotech company Prime Medicine, Cambridge, Massachusetts.

"Our focus is to provide an alternative for the early detection of lung cancer that does not rely on resource-intensive infrastructure," said Tan. "Most developing countries don't have such resources" — and residents in some parts of the United States don't have easy access, either, he said.

How It Works

The sensors are polymer nanoparticles coated in DNA barcodes, short DNA sequences that are unique and easy to identify. The researchers engineered the particles to be targeted by protease enzymes linked to stage I lung adenocarcinoma. Upon contact, the proteases cleave off the barcodes, which make their way into the bloodstream and are excreted in urine. A test strip can detect them, revealing results about 20 minutes from the time it's dipped.

Nanosensors that target lung cancer proteins can be aerosolized and delivered with an inhaler or nebulizer.

The researchers tested this system in mice genetically engineered to develop human-like lung tumors. Using aerosol nebulizers, they delivered 20 sensors to mice with the equivalent of stage I or II cancer. Using a machine learning algorithm, they identified the four most accurate sensors. With 100% specificity, those four sensors exhibited sensitivity of 84.6%.

"One advantage of using inhalation is that it's noninvasive, and another advantage is that it distributes across the lung quite homogeneously," said Tan. The time from inhalation to detection is also relatively fast — in mice, the whole process took about 2 hours, and Zhong speculated that it would not be much longer in humans.

Other Applications and Challenges

An injectable version of this technology, also developed at MIT, has already been tested in a phase 1 clinical trial for diagnosing liver cancer and nonalcoholic steatohepatitis. The injection also works in tandem with a urine test, the researchers showed in 2021. According to Tan, his research group (led by Sangeeta Bhatia, MD, PhD) was the first to describe this type of technology to screen for diseases.

The lab is also working toward using inhalable sensors to distinguish between viral, bacterial, and fungal pneumonia. And the technology could also be used to diagnose other lung conditions like asthma and chronic obstructive pulmonary disease, Tan said.

The tech is certainly "innovative," remarked Gaetano Rocco, MD, a thoracic surgeon and lung cancer researcher at Memorial Sloan Kettering Cancer Center, Middletown, New Jersey, who was not involved in the study.

Still, challenges may arise when applying it to people. Many factors are involved in regulating fluid volume, potentially interfering with the ability to detect the compounds in the urine, Rocco said. Diet, hydration, drug interference, renal function, and some chronic diseases could all limit effectiveness.

Another challenge: Human cancer can be more heterogeneous (containing different kinds of cancer cells), so four sensors may not be enough, Zhong said. He and colleagues are beginning to analyze human biopsy samples to see whether the same sensors that worked in mice would also work in humans. If all goes well, they hope to do studies on humans or nonhuman primates.

https://www.medscape.com/viewarticle/how-simple-urine-test-could-reveal-early-stage-lung-cancer-2024a10001ib

Federal watchdog to probe FDA's handling of major device recalls

Following a series of reports on the FDA’s alleged history of mishandling medical device recalls, which in turn sparked a request for a government probe of the regulator, the U.S. Government Accountability Office has agreed to take on the job.

The GAO—the independent watchdog arm of the U.S. Congress—has accepted the investigation request and is aiming to launch the probe soon, an agency representative confirmed to Fierce Medtech.

ProPublica was first to report the news Wednesday; the outlet, together with the Pittsburgh Post-Gazette, is responsible for the series of reports that inspired the request for a congressional investigation.

That request came from Democratic Sens. Dick Durbin of Illinois and Richard Blumenthal of Connecticut, who penned a mid-December letter to Gene Dodaro, head of the GAO, asking him to dig into the FDA’s processes for handling recalls—and, ultimately, to update a 2011 GAO report that requested the FDA “enhance its oversight of recalls.”

The senators argued that it’s high time for a new accounting since the numbers of medtech recalls and medical device reports (MDRs) submitted to the FDA have significantly increased in the years since the GAO’s last probe.

They mapped out a series of 10 questions that a new investigation would answer, tasking the GAO with examining, for example, how the FDA enforces legal requirements around recalls—if at all—and how it’s using MDRs to inform its handling of recalls. The senators also suggested that the investigators determine how certain legislative funding and other support could improve the FDA’s performance.

Durbin and Blumenthal specifically credited ProPublica and the Post-Gazette’s reporting on the matter for spurring them to send the letter. Just a week before the senators issued their request, the outlets had published a report detailing what they described as a longstanding pattern of “regulatory failure” at the FDA.

Their analysis found that the FDA has often allowed devicemakers to pass along MDRs later than the 30-day deadline—and to backdate them as necessary—without facing any major consequences, though the FDA could be pursuing criminal charges for those violations.

That allegedly lax attitude extends to Philips’ ongoing recall of several million respiratory devices. Though previous reporting from ProPublica and the Post-Gazette suggested that Philips had failed to pass along thousands of complaints about the devices in the decade before the recall began in 2021, their FDA-focused report noted that the agency, for its part, had largely failed to act on the MDRs that it did receive from Philips during that period—and then allowed Philips to submit thousands of complaints late with no penalty, keeping their original dates “concealed … from the public,” per the report.

https://www.fiercebiotech.com/medtech/gao-accepts-senators-request-probe-fdas-handling-recalls-philips-other-devicemakers

Abbott launches first human trials of pulsed field ablation system for afib as sector grows

 With Medtronic and Johnson & Johnson securing international approvals in the nascent domain of pulsed field ablation, Abbott is looking to join the party with its own approach for treating atrial fibrillation and other arrhythmias.

Abbott announced it has begun conducting the first human procedures using its new Volt system, which comes combined with its EnSite X cardiac mapping platform, through a clinical study of more than 30 patients in Australia. 

The company said it plans to examine the device in additional markets across the Asia-Pacific region and in Europe as it takes steps toward securing a CE mark approval. Abbott added that it expects to receive a green light for a U.S. clinical trial in the first half of this year.

Pulsed field ablation employs short bursts of electric energy that disrupt heart muscle cells more than others. The technology aims to avoid generating the excess heat or cold that can cause some of the major complications seen with thermal ablation, such as damage to the surrounding nerves and blood vessels or adjacent vital organs like the esophagus.

Abbott's Volt system uses a balloon-in-basket catheter design to help transfer energy into the cardiac tissue, while EnSite X assists surgeons in accurately positioning the catheter within the heart, with the goal of reducing the need for X-ray radiation exposure and real-time image guidance.

“Daily life for the millions of people with afib can be difficult as symptoms often include palpitations, shortness of breath, dizziness and chest pain, making it critical that physicians treat the issue as soon as possible,” Christopher Piorkowski, chief medical officer of Abbott's electrophysiology business, said in a statement. 

“With afib cases expected to rise continuously, Abbott's Volt PFA system meets a growing demand for a more innovative solution that reduces the patient procedure time and overall hospital stay, getting them back to living a fuller, longer life,” Piorkowski added.

Last month, Medtronic garnered the FDA’s first approval of a pulsed field ablation system with its PulseSelect hardware. Prior to that, the company received CE marks for PulseSelect and its dual-use Affera catheter that delivers both pulsed field and radiofrequency ablation.

Meanwhile, J&J’s Biosense Webster division recently scored a green light in Japan for its Varipulse platform, bundled with its Carto 3D cardiac mapper. The system is currently under review in Europe.

At the same time, Boston Scientific said it expects to obtain approval from the FDA for its Farapulse catheter by the end of March. That device received a CE mark approval in early 2021, not long before Boston Scientific acquired it and its eponymous developer for $295 million following a lengthy collaboration.

But pulsed field ablation hasn’t just been exclusive to the largest medtechs: Startups, too, have been developing new approaches for what is projected to grow into a multi-billion-dollar market in the coming years.

Cortex, supported by incubator Ajax Health, announced $90 million in financing commitments late last year as it works on an integrated system that can diagnose arrhythmias as well as treat them. Field Medical, meanwhile, collected $14 million in seed funding last September after being launched in 2022 by one of the previous founders of Farapulse.

https://www.fiercebiotech.com/medtech/abbott-launches-first-human-trials-its-pulsed-field-ablation-system-afib-sector-grows

FDA, CMS issue joint letter supporting increased oversight of lab-developed tests

 Leadership at the FDA and the Centers for Medicare and Medicaid Services issued a joint statement to reiterate plans to increase the federal oversight of lab-developed tests, commonly known as LDTs.

Last September, the FDA published a long-expected proposal to bring those types of tests in line with how the agency treats other in vitro diagnostics, with a multi-year timeline that would phase in reviews and other regulatory requirements through 2028.

LDTs had originally been designated a lower-risk category, since they were comparatively less complex tests and typically produced in small volumes by individual laboratories, including many on an as-needed basis. However, LDTs and their uses have evolved in recent years—in both their technology and their nationwide commercial reach, according to FDA and CMS.

“For example, the FDA is aware of tests offered as LDTs that could have led to patients being over- or under-treated for heart disease; patients with cancer being exposed to inappropriate therapies or not getting effective therapies; and incorrect diagnoses of rare diseases, autism and Alzheimer’s Disease,” wrote the FDA’s device center director, Jeff Shuren, and CMS’ acting director of the Center for Clinical Standards and Quality, Dora Hughes, in their joint letter.

“Other evidence, including published literature and the FDA’s experience with tests to diagnose COVID-19, suggests that the situation is getting worse,” they said, adding that physicians today base about 70% of healthcare decisions on lab tests and that the government believes results should be proven to be accurate regardless of where the product is made.

The American Clinical Laboratory Association, the trade group representing diagnostic testing labs, has urged the FDA to withdraw its proposed rule, writing last December that the changes would jeopardize laboratories’ abilities to continue developing new, cutting-edge LDTs. 

“The net result of this action would be to reduce patient access to essential testing, including for rare diseases, and hamper innovation in the next generation of diagnostics,” ACLA President Susan Van Meter said in a statement at the time. “Device authorities are rigid and would not allow LDTs to keep pace with scientific advances.”

In its extended comments (PDF) on the FDA’s proposed regulation, the ACLA also pointed to the suite of CLIA regulations that currently apply to accredited clinical labs—which direct them to be staffed by trained personnel and also set down quality requirements and proficiency standards.

In their letter, Shuren and Hughes underlined that CLIA regulates laboratories, not the tests themselves. To show again how the issue has changed, they pointed to a fact sheet (PDF) on LDTs issued by CMS in 2013, which described a “complementary” regulatory approach from the two federal agencies.

“That said, a decade later, in connection with the FDA’s notice of proposed rulemaking, we are—together—reiterating that CMS’s CLIA program is separate in scope and purpose from FDA oversight,” they wrote. 

“Some have suggested that concerns with LDTs should be addressed through the expansion of CLIA. This is not the answer,” said Shuren and Hughes, adding that “CMS does not have the expertise to assure that tests work; the FDA does.” 

“Both CMS and the FDA believe that patients and their doctors need to know that LDTs are valid. … The FDA and CMS have long stood together in mutual support of FDA oversight of the analytical and clinical validity of LDTs,” they wrote.

Meanwhile, the medical device industry group AdvaMed and its diagnostics division, AdvaMedDx, have supported the FDA’s ability to “clarify the regulatory definition of in vitro diagnostics to encompass tests manufactured within a laboratory setting,” but said in their own submitted comments (PDF) that the public would benefit more from comprehensive diagnostics regulation reform, which would require legislation to be passed by Congress.

https://www.fiercebiotech.com/medtech/fda-cms-issue-joint-letter-supporting-increased-oversight-lab-developed-tests

Israeli army says it found Gaza tunnel for hostages

 The 55th Brigade's forces engaged in close quarters combat in southern Gaza in the past few days, the IDF said in a post on Telegram.

It went on to say soldiers found and dismantled tunnel shafts and observation posts belonging to Hamas.

Reuters was not able to independently verify the location or the date when the video was filmed.

Israeli military spokesman Rear Admiral Daniel Hagari said soldiers found a holding area, five narrow rooms behind metal bars, toilets, mattresses, and even drawings by a child hostage who was freed during a November truce.

No hostages were there when it was discovered.

The military released photos from the underground labyrinth and said it brought in journalists to document the tunnel before it was destroyed.

https://news.yahoo.com/supreme-court-looks-set-steve-104603308.html

Biden challenger Phillips, in New Hampshire, calls Biden weak, unelectable

 A U.S. congressman looking to thwart President Joe Biden, a fellow Democrat, from a second term assailed Biden as weak and unelectable on Saturday as he tried to take advantage of Biden's absence from New Hampshire's first-in-the-nation primary.

Biden is skipping the New Hampshire primary after the Republican-run state refused his demand to give up its first in nation primary spot to South Carolina. But Biden's supporters are mounting a write-in campaign to avoid an embarrassing loss in the state on primary election day on Tuesday.

Congressman Dean Phillips, a wealthy Democrat from Minnesota who is running for president, said during a campaign event in Nashua, New Hampshire, that he hoped to expose what he called Biden's weakness by doing well in Tuesday's voting.

Phillips said a strong showing by him would be getting upwards of 20% or more of the vote - "going from zero to somewhere in the 20s would be pretty awesome, I think."

"Sadly it's going to demonstrate that our incumbent president is unelectable and weak and I think it's going to show this country that there's a candidate here who can actually do here what has been promised for generations," Phillips told reporters after addressing dozens of people at a senior citizen activity center.

He also noted Biden's advanced age, 81.

"If you listen to the voters, people feel he's at a stage of life that makes it incompatible to leading the free world. And the same is true of Donald Trump," said Phillips, 55.

Trump, 77, is the leading Republican candidate. The former president was defeated by Biden in his bid for a second term in 2020.

The Biden re-election campaign did not respond immediately to a request for comment.

The New Hampshire primary on Jan. 23 offers the first at-the-polls gauge of Biden’s political strength this election cycle, and the unprecedented situation will be closely watched amid polls showing him tied with Trump.

A poor showing by Biden against Phillips and self-help author Marianne Williamson would likely fuel concerns that Biden is weak heading into the general election.

Both Phillips and Williamson appeared to have little chance of defeating Biden.

Backers of the write-in campaign are staging events throughout the weekend to educate voters on how to write in Biden's name and generate support for him.

Williamson told several dozen people at an event in Manchester that she also felt Biden was weak and questioned the wisdom of nominating him for a second term just because he beat Trump in 2020.

"To say he beat Trump once and therefore he'll beat him again - for me it's like saying to an actor who's nominated for an Oscar twice. 'He won last time so it's only reasonable to think he'll win this time. Well, it's a different movie," she said.

https://news.yahoo.com/biden-challenger-phillips-hampshire-calls-000314699.html