Labcorp launches online platform for ordering at-home tests, scheduling in-person appointments

 Building on the success of its direct-to-consumer COVID-19 testing options, Labcorp has established a new platform that allows it to sidestep healthcare provider middlemen and enable individuals to order their own diagnostic tests.

With Labcorp OnDemand, consumers can choose from a wide range of tests and multitest packages, all available without a physician’s referral. Depending on the type, the diagnostics can either be ordered for at-home sample collection or the buyer will be prompted to schedule an appointment at one of Labcorp’s patient service centers, 2,000 of which are located in Walgreens stores and standalone labs across the U.S.

Regardless of how the sample is collected, after it’s been processed by Labcorp, the results are automatically available on the OnDemand platform’s online portal. The resulting report not only explains each test’s results and highlights potential areas of concern but can also be shared with healthcare providers.

Several dozen tests and packages are available from the OnDemand site, including diagnostics to screen for COVID, pregnancy, diabetes risk, sexually transmitted infections, colorectal cancer and more. Prices range from $29 for a routine urine analysis or complete blood count test to $199 for an allergy test or a comprehensive health screening, and insurance is not accepted.

Though the platform is initially being launched as a direct-to-consumer offering, Labcorp said it plans to make its OnDemand tests available through physicians, insurers and employers over the course of this year.

Labcorp OnDemand replaces Pixel by Labcorp, the diagnostics giant’s original foray into direct-to-consumer testing. The Pixel platform launched in 2018 with a handful of health screening packages, all of which used samples collected at home and mailed to Labcorp in included postage-paid boxes. It eventually grew to include more than two dozen diagnostic kits, some of which required in-person specimen collection.

The Pixel name is now attached only to Labcorp’s at-home collection kits for COVID and combined COVID and flu PCR testing.

The launch of the OnDemand online store builds on Labcorp’s digital health offerings, which were further expanded just a few months ago with the acquisition of Ovia Health.

The Ovia platform is designed to provide support for women through the processes of family planning, pregnancy and parenting. It not only connects them with necessary testing and screening but also offers educational resources and matches them to clinical trials they may be eligible to join.

https://www.fiercebiotech.com/medtech/labcorp-launches-online-platform-for-ordering-at-home-tests-scheduling-person-appointments

Tasso, Vault Health team up to provide at-home blood testing for siteless clinical trials

 Tasso, developer of a wearable blood collection device, is pairing up with telehealth provider Vault Health to help simplify the process of performing diagnostic tests at home.

Vault offers remote services such as COVID-19 testing as well as drug and alcohol screenings for employers. The company also provides logistics for decentralized clinical trials, including sample collection and analysis.

The addition of Tasso’s OnDemand blood collection device—a small piece of push-button hardware that attaches to the upper arm and draws blood from the skin’s capillaries through a process the companies describe as “virtually painless”—will allow users and study participants to ship liquid or dried samples through the mail with no training necessary. 

Last December, Tasso tapped into $100 million in venture capital to scale up production of its device and bolster its commercial reach after raising just $17 million to kick off operations in mid-2020.

OnDemand received a CE mark approval in Europe in May 2021, and Tasso has said its devices have since been used in siteless clinical trials and biopharma research as well as for remote patient monitoring.

Vault Health, meanwhile, began working with DoorDash early last year to have the company deliver its COVID-19 tests to people’s homes. The kits include the swabs and tubes necessary to gather a sample and ship it to a lab for results.

https://www.fiercebiotech.com/medtech/tasso-vault-health-team-up-to-provide-at-home-blood-testing-for-siteless-clinical-trials

Aussies curlers out of Olympics, back in, then win 1st game

 After getting a devastating morning phone call that she had tested positive for COVID-19, Tahli Gill and her Australian mixed doubles curling teammate Dean Hewitt were out of the Beijing Olympics.

A few hours later, another call. They were back in.

They barely had enough time to grab their uniforms out of their packed bags — a flight home had been booked for Monday — jump in a cab and get from the Olympic Village to the Ice Cube for a game against Switzerland.

Highlighting a day they’ll never forget, Gill threw the takeout shot that resulted in a three-ender, or three points, that tied the game at 6 in the sixth end. The Aussies won 9-6 for their first victory after opening their first Olympics with seven straight losses.

They fist-bumped Swiss curlers Martin Rios and Jenny Perret, hugged each other and then waved to a spectator who occasionally had yelled, “Aussie, Aussie, Aussie!” in the mostly empty arena.

“You know what? They just experienced the COVID Olympics 101 right there,” said the Aussie duo’s coach, defending mixed doubles gold medalist John Morris of Canada. “I’m sure it was a really tough time for Tahli. I was heartbroken for her when I heard they were out. I’m absolutely ecstatic they’re still playing in this.”

Coincidentally, the Aussies’ final game of the Olympics was Sunday night against Morris and his new partner, Rachel Homan. The Aussies blew a 7-0 lead but won 10-8 in an extra end.

Also Sunday night, Chris Plys and Vicky Persinger of the United States were eliminated from playoff contention after a 6-5 loss to Switzerland. The top four teams advance to the semifinals Monday night, following the final session of the round robin. Italy, already qualified for the playoffs, improved to 8-0 with a 12-8 win against Sweden.

The Australian Olympic Committee announced late Sunday morning that Gill returned a series of positive tests the night before and that rather than having her go into an isolation hotel, she and Hewitt would be heading home.

But the AOC continued to press her case, and shortly before the scheduled game time of 2:05 p.m., it announced that the medical expert panel examined Gill’s CT values —considered an indicator of how much virus an infected person is carrying — following PCR testing during the previous 24 hours and determined that they fell into an acceptable range. With that, the Aussies were back in.

Gill had COVID-19 before the Olympics and had been allowed to compete under the close contact program, at least until the positive tests late Saturday.

“It’s just been the craziest time,” Gill said. “It was down to the wire, pretty much. The medical team, they were able to review it. I’m so grateful that they put forward a good case. It just shows I’m not infectious.”

After getting cleared to play, it was such a scramble digging through her luggage, literally ripping out clothes to get to her uniform, that Gill grabbed the wrong glove.

“It was really crazy, but I think the fact that we were able to regroup, refocus and pull it off is really cool, and definitely something we’re going to take as a learning development going forward,” she said. “It’s just been the most amazing experience.”

Gill and Hewitt were the first Australian curlers to qualify for the Olympics.

“You don’t realize what you’ve got until it’s gone,” Hewitt said. “Once we heard that we actually could play again, it made it extra special for us. Embrace the Olympics, embrace what we had and be grateful for it because it’s something that can be taken away from you at a moment’s notice. We’re so stoked and we can’t wait for our next game as well.”

Rios said the Swiss found out just before getting on the bus to the Ice Cube that Gill had tested positive.

“Now we have two years of experience with the epidemic, so it’s back to unexpected,” he said.

Curlers are known for their camaraderie and sportsmanship. Rios said he was glad the game was played and that they didn’t have to accept a forfeit win.

“We showed up here and there was no official forfeit. I prefer a deserved loss to a forfeit win, to be honest,” Rios said. “They are nice guys and I hope they’re well and can enjoy the rest of this. They’re good curlers. Of course, they were 0-7, but we knew they would give us a hard time on the ice.”

The Swiss had a three-ender in the fourth end for a 4-3 lead but couldn’t hold on.

“They fought back and in the end we were not able to fight back again,” Rios said, “and so they deserved to win.”

https://apnews.com/article/winter-olympics-curling-coronavirus-pandemic-sports-health-a4898a759a1d77cdcb841b6a2c314a2d

Will States Rein in Nurse Staffing Agencies?

 

A letter about staffing agency price gouging that members of Congress sent to the White House has some corners of the nursing community abuzz over possible implications, particularly whether the growing scrutiny could lead to state-level restrictions.

The letter asked the COVID-19 Response Team to investigate nurse staffing agencies for allegedly "artificially inflating" prices during a crisis by charging hospitals exorbitantly for the services of their nurses, citing reports representatives say they've received.

For nurses, alarm bells began to ring. An investigation into staffing agency prices could mean more legislation to cap what staffing agencies can charge hospitals and other facilities in some states, and in the process, some noted online, limit wages for nurses themselves.

The American Nursing Association (ANA) wrote in an email to MedPage Today that it supports an effort like this only if it targets agencies themselves while protecting nurse pay. "If legislation were to directly impact [staffing agency] overhead, then we believe nurses' pay would not be impacted," the organization wrote. "However, if staffing agencies were capped at a certain percentage of pre-pandemic rates, then nurses could potentially see a decrease in wages."

Travel nurses, though a small percentage of total nurses, have been afforded a chance to choose better compensation and work more flexible hours during a time when they may have felt overworked and undervalued, ANA wrote in a separate statement. The association reiterated to MedPage Today that travel nurses should not be negatively impacted in the process of reigning in price gouging.

ANA suggested instead that Congress should enact policies that would help retain and attract nurses, adjust the Medicare area wage index, and restrict mandatory overtime. It also backed enacting laws like the Dr. Lorna Breen Health Care Provider Protection bill, which would establish grants for workplaces that promote healthcare worker mental health, and the Future Advancement of Academic Nursing bill, which would provide support for nursing schools in underserved areas.

The letter itself said nothing about capping wages, although a widely viewed Reddit post characterized it as "large attempts in Congress right now to cap nurse (especially travel nurse) pay." The letter-writers framed their concerns as a problem with the agencies themselves and their cut of the ballooning prices, citing reports of agencies "taking 40% or more of the amount being charged to the hospitals for themselves in profits." Nurses themselves, they imply, aren't reaping most of the benefits.

Meanwhile, some nursing home associations and hospitals said lower costs for temporary staffing would allow them to hire more nurses and relieve short-staffed facilities, thereby improving the nurse-to-patient ratio. But on a Facebook group for travel nurses, a post about striking if states attempt to cap travel nurse wages garnered a thousand likes and over 300 comments. "If anyone is foolish enough to try to cap RN pay, it is going to make an already bad staffing problem much worse. Critically worse," one comment read. "How about we cap the pay of all the fat-cat CEOs and administrators?"

Landry Seedig, group president and chief operating officer of nursing and allied solutions at AMN Healthcare, a leading staffing agency, told MedPage Today in an email that they're charging more to attract limited nurses in a shortage. "Hospitals set bill rates for all travel nurses," Seedig said. "Many hospitals throughout the country would be overwhelmed if not for travel nurses and other travel healthcare professionals."

Although 42 states have existing "price gouging" laws that go into effect in an emergency, few have had laws specifically regulating staffing agency services until the pandemic exacerbated frustrations with the delivery of healthcare.

Minnesota enacted a law in 2001 requiring nursing service agencies to register with the state and to not charge nursing homes a rate more than 150% of the average wage rate for their specific employee role and designated geographic area. In December 2020, the state published new hourly rates effective Jan. 1, 2021, to accommodate pandemic staffing needs. They also allowed agencies to apply for wage cap waivers in an emergency.

Massachusetts in March 2020 adopted an emergency amendment to expand an existing law from prohibiting price gouging for petroleum to now cover goods and services too. The state already had existing caps on rates staffing agencies can charge both hospitals and nursing homes for nurses and other healthcare staff, including travel nurses. In May 2020, the state raised the cap by 35% for nursing facilities for the COVID-19 emergency. It also sent a memo in February 2021 reminding staffing agencies that they could be disciplined for going over the rates.

Other states are considering similar laws.

In Pennsylvania, state Rep. Timothy Bonner (R) introduced a bill that, he wrote in a November 2021 memo, "would establish maximum rates on agency health care personnel to end the practice of 'gouging' the Medicaid program and Pennsylvania taxpayers, which was already exacerbated by the COVID-19 pandemic." Like Minnesota, staffing agencies would have to register with the state's Department of Human Services.

In Connecticut, the AP reports, state nursing home associations hoping for legislative action on staffing agency pricing have met with the governor to discuss caps on agencies.

Illinois recently amended its Freedom to Work Act, protecting some workers from non-compete and non-solicit clauses, potentially reducing the power of staffing agencies and making it easier for temporary healthcare workers to be hired as permanent staff.

https://www.medpagetoday.com/special-reports/exclusives/97026

How Do Cancer Biosimilars Stack Up Against the Original Products?

 Clinical trials evaluating biosimilars for cancer drugs appeared to be well-designed and showed results that were "statistically indistinguishable" from those of the original products, according to findings from a systematic review and meta-analysis.

The 31 cancer biosimilar studies of three reference drugs involved more patients than the original drug trials (mean number of patients 397 vs 302), were more likely to be randomized trials than single-group or observational studies (100% vs 50%), and were more likely to be double-blind rather than open-label (84% vs 17%), reported Aaron Kesselheim, MD, JD, MPH, of Brigham and Women's Hospital and Harvard Medical School in Boston, and colleagues.

"Our results do support patient and physician confidence in the efficacy and extent of testing of currently available biosimilars to treat cancer," they wrote in JAMA Oncology. "More widespread use of these products may help promote price-lowering competition."

Kesselheim and colleagues pointed out that while biologics are used by fewer than 2% of people in the U.S., they contribute to a significant share of prescription drug costs. Fostering competition with biosimilars has been expected to lower pricing and overall spending. However, once approved, biosimilars and the original products are not considered to be interchangeable, with some physicians remaining skeptical about their relative efficacy.

In this meta-analysis, the study authors assessed 31 biosimilar studies of bevacizumab (Avastin), trastuzumab (Herceptin), and rituximab (Rituxan) involving 12,310 patients compared with six original drug trials involving 1,811 patients.

The conclusions from this analysis "are reassuring to oncologists and their patients with lymphoma, breast cancer, and other cancers treated with these agents," wrote Douglas W. Blayney, MD, of Stanford University School of Medicine in California, and Samuel M. Silver, MD, PhD, of the University of Michigan Medical School in Ann Arbor, in an editorial accompanying the study.

"We should refine the methodology for future meta-analyses, continue patient-level observations to detect potential long-term differences among the agents and detect rare side effects that may emerge with wider biosimilar use," they continued. "Further investigations should be directed to reassure us that the biosimilar development program is delivering value."

Bevacizumab

Kesselheim and colleagues identified 11 studies comparing bevacizumab with a biosimilar. Six trials included patients with non-small cell lung cancer (NSCLC), while the other five included patients with metastatic colorectal cancer (CRC).

The analysis of the NSCLC studies, which all had a primary outcome of overall response rate (ORR), showed a summary risk ratio estimate of 1.02 (95% CI 0.94-1.10).

An analysis of three CRC studies with ORR as the primary outcome demonstrated a summary risk ratio estimate of 0.95 (95% CI 0.72-1.24), while two CRC studies with progression-free survival as the primary outcome showed a risk ratio estimate of 0.91 (95% CI 0.80-1.04).

Trastuzumab

Among five studies of patients with ERBB2-positive early breast cancer and four studies of those with ERBB2-positive metastatic breast cancer given trastuzumab or a biosimilar with a primary endpoint of ORR, there were no differences between the originator and the biosimilars, with summary risk ratio estimates of 1.08 (95% CI 0.95-1.24) for the early breast cancer studies, and 1.01 (95% CI 0.94-1.08) for the metastatic studies.

Rituximab

Ten studies evaluated the originator rituximab with a biosimilar -- seven for follicular lymphoma and three for diffuse large B-cell lymphoma. (A study on chronic lymphocytic leukemia was not included in the meta-analysis.) Again, no differences were found between the biosimilar and originator, with summary risk ratio estimates of 1.04 (95% CI 1.00-1.08) for follicular lymphoma and 1.01 (95% CI 0.96-1.05) for diffuse large B-cell lymphoma.

Kesselheim and colleagues noted that "[c]onducting large and expensive pivotal trials for biosimilar molecules that have already shown a high degree of similarity in pharmacokinetics and safety in smaller studies creates barriers to entry and reduces expected competition."

"The comparative size and rigor of the biosimilar trials in this study, particularly in light of the near-universal finding of noninferiority, thus raise important questions about how much testing should be required of biosimilars," they continued. "As the reliability and reproducibility of scientifically assessing biosimilars continue to develop, such similar outcomes will allow regulators to become more flexible with the extent of preapproval testing."

Disclosures

This study was supported by Arnold Ventures.

Kesselheim reported no disclosures. A co-author currently serves as a judicial clerk at the U.S. Court of Appeals for the District of Columbia Circuit. This article was written before his clerkship and represents only his personal views.

Blayney reported owning stock in Berkshire Hathaway, Madorra, and Artelo Biosciences, and relationships with BeyondSpring Pharma and Artelo. Silver reported personal fees from McGivney Global Advisors.

Primary Source

JAMA Oncology

Source Reference: Bloomfield D, et al "Characteristics of clinical trials evaluating biosimilars in the treatment of cancer: a systematic review and meta-analysis" JAMA Oncol 2022; DOI: 10.1001/jamaoncol.2021.7230.

Secondary Source

JAMA Oncology

Source Reference: Blayney DW, Silver SM "Cancer biosimilars -- a regulatory success so far, but value still to be determined" JAMA Oncol 2022; DOI: 10.1001/jamaoncol.2021.6979.

https://www.medpagetoday.com/hematologyoncology/othercancers/97027

Key Growth Factor Protects Gut from Inflammatory Bowel Disease

 A growth factor protein produced by rare immune cells in the intestine can protect against the effects of inflammatory bowel disease (IBD), according to a new discovery from Weill Cornell Medicine researchers.

In their study, published Jan. 31 in Nature Immunology, the researchers found that the growth factor, HB-EGF, is produced in response to gut inflammation by a set of immune-regulating cells called ILC3s. These immune cells reside in many organs including the intestines, though their numbers are known to be depleted in the inflamed intestines of IBD patients.

The researchers showed in experiments in mice that this growth factor can powerfully counter the harmful effects of a key driver of intestinal inflammation called TNF. In doing so, ILC3s protect gut-lining cells when they would otherwise die and cause a breach in the intestinal barrier.

Dr. Gregory Sonnenberg

“We’ve discovered a new cellular pathway that is essential to protect against gut inflammation. This discovery could lead to a better understanding of IBD pathogenesis and new strategies to treat this disease” said study senior author Dr. Gregory Sonnenberg, an associate professor of microbiology and immunology in medicine in the Division of Gastroenterology and Hepatology and a scientist in the Jill Roberts Institute for Research in Inflammatory Bowel Disease at Weill Cornell Medicine.

IBD, a disease category including ulcerative colitis and Crohn’s disease, features chronic gut inflammation and many potential follow-on effects including arthritis and colorectal cancer. The condition appears to be quite common in the United States; a survey-based study by researchers at the Centers for Disease Control and Prevention in 2015 suggested that more than 1 percent of the U.S. population—more than three million people—were living with IBD. Current treatments help some but not all patients.

Dr. Sonnenberg and his laboratory have found in recent studies that ILC3s play a key role in protecting the gut from harmful inflammation and are depleted in human patients who have IBD or colon cancer. In the new study, the team sought a more precise understanding of how ILC3s fight against IBD’s inflammatory effects.

The researchers in an initial set of experiments recreated an IBD-like condition in mice using high doses of an inflammatory immune protein called TNF, a major driver of inflammation in IBD and the target of some IBD therapies. They found in these experiments that ILC3s strongly protect the gut linings of the mice from TNF-induced inflammatory damage—mice lacking ILC3s suffered significantly worse damage.

Prior studies have suggested that ILC3s help protect the gut at least in part by producing an immune protein called IL-22, which promotes gut barrier function. However, the mouse experiments in the new study indicated that ILC3s’ gut-protecting effect against TNF works independently of IL-22.

Using a relatively advanced technique called single-cell RNA sequencing, the researchers eventually zeroed in on the mechanism of ILC3s’ protective effect: the growth factor protein HB-EGF, which they showed could specifically keep gut-lining cells alive in the presence of excessive TNF.

The team found that ILC3s are the dominant producers of HB-EGF in the gut. They were able to identify the cascade of signaling factors that occurs downstream of TNF and causes ILC3 to switch on HB-EGF production—and they observed the same cascade in human ILC3s, indicating that these findings are not just specific to mice. The researchers also confirmed from analyses of IBD-patient gut tissue that HB-EGF-producing ILC3s are reduced in areas of gut inflammation.

The findings reveal a key mechanism that the gut normally uses to protect itself from harmful inflammation and suggest that the loss of ILC3s is at least one reason this mechanism fails in IBD.

“Identifying the significance of this pathway is a good first step, and we’re now thinking about how we might manipulate this pathway to benefit IBD patients,” Dr. Sonnenberg said.

The loss of ILC3s in the IBD gut poses a challenge to the development of therapeutic solutions that depend on ILC3s, he noted. Moreover, though the growth factor HB-EGF on its own could be therapeutic, even if ILC3s are depleted, HB-EGF has been linked to the faster growth of a variety of cancers.

Dr. Lei Zhou

“Our ongoing research is interrogating the role of this ILC3 and HB-EGF pathway in the development of chronic-inflammation-related colon cancer,” said study first author Dr. Lei Zhou, a postdoctoral associate in the Sonnenberg laboratory. “It will be important to delineate the exact cellular and molecular mechanisms by which this novel pathway coordinates intestinal health, inflammation and cancer before moving forward with manipulating it as a therapeutic strategy.”

The Sonnenberg Laboratory is supported by the National Institutes of Health (R01AI143842, R01AI123368, R01AI145989, R01AI162936, R21CA249284 and U01AI095608), the NIAID Mucosal Immunology Studies Team (MIST), the Crohn’s and Colitis Foundation, the Searle Scholars Program, the American Asthma Foundation Scholar Award, Pilot Project Funding from the Center for Advanced Digestive Care (CADC), an Investigators in the Pathogenesis of Infectious Disease Award from the Burroughs Wellcome Fund, a Wade F.B. Thompson/Cancer Research Institute (CRI) CLIP Investigator grant, the Meyer Cancer Center Collaborative Research Initiative, the Dalton Family Foundation, Linda and Glenn Greenberg, and the Roberts Institute for Research in IBD. Gregory F. Sonnenberg is a CRI Lloyd J. Old STAR. Lei Zhou is supported by a fellowship from the Crohn’s and Colitis Foundation (608975).

https://news.weill.cornell.edu/news/2022/01/key-growth-factor-protects-gut-from-inflammatory-bowel-disease

Inverse link in serum 25-hydroxyvitamin D, nonalcoholic fatty liver disease

 ShuaiYuanB.Med, MMedSc1Susanna C.LarssonPhD12

DOI: https://doi.org/10.1016/j.cgh.2022.01.021

PDF: https://www.sciencedirect.com/science/article/pii/S1542356522000751/pdf?md5=7629c1eda040ced87a3f9cc86fc01f8e&pid=1-s2.0-S1542356522000751-main.pdf

Abstract

Background & Aims

Serum 25-hydroxyvitamin D (S-25(OH)D) and nonalcoholic fatty liver disease (NAFLD) are correlated in many observational studies, whereas the causality of this association is uncertain, especially in European populations. We conducted a bidirectional Mendelian randomization study to determine the association between S-25(OH)D and NAFLD.

Methods

Seven and six independent genetic variants associated with S-25(OH)D and NAFLD at the genome-wide significance level, respectively, were selected as instrumental variables. Summary-level data for S-25(OH)D were obtained from the SUNLIGHT consortium including 79,366 individuals. Summary-level data for NAFLD were available from a genome-wide association meta-analysis (1483 cases and 17,781 controls), the FinnGen consortium (894 cases and 217,898 controls), and the UK Biobank study (275 cases and 360,919 controls). Summary-level data for four liver enzymes were obtained from the UK Biobank.

Results

There were genetic correlations of S-25(OH)D with NAFLD and certain liver enzymes. Genetically predicted higher levels of S-25(OH)D were consistently associated with a decreased risk of NAFLD in the three sources. For one standard deviation increase in genetically predicted S-25(OH)D levels, the combined odds ratio of NAFLD was 0.78 (95% confidence interval (CI), 0.69, 0.89). Genetically predicted higher levels of S-25(OH)D showed a borderline association with aspartate aminotransferase levels (change -0.17, 95% CI, -0.36, 0.01). Genetic predisposition to NAFLD was not associated with S-25(OH)D (change 0.13, 95% CI, -0.26, 0.53).

Conclusions

Our findings have clinical implications as they suggest that increased vitamin D levels may play a role in NAFLD prevention in European populations.

https://www.sciencedirect.com/science/article/pii/S1542356522000751