While laboratory values and condition-focused testing dominated LabPulse.com's Top 10 most-read posts of last year, a particular type of biomarker and tissue imaging study took the top spot in 2024. Are more studies ahead exploring the effects of glucagon-like peptide-1 (GLP-1) drugs?
Some of this year's biggest moments include the mid-year report highlighting $2.75 billion worth of fraud that involved lab testing, as well as other troubling money matters with payers and the rising popularity of Z-Codes.
The hottest topic quickly making a splash at the end of the year is a U.S. Department of Veterans Affairs (VA) pilot program offering no-cost pharmacogenomic (PGx) testing and PGx patient education to veterans.
Revisit LabPulse.com's Top 10 stories of 2024 in the snapshots below.
Biomarker, tissue study shows body composition in patients treated with Ozempic
LabPulse.com's most viewed story explained an important discovery made through biomarker testing and tissue imaging in people taking popular drugs like Ozempic and Wegovy.
University of Wisconsin researchers assessed tissue-level changes in body composition after initiation of a newer class of drugs, glucagon-like peptide-1 (GLP-1) agonist treatment (semaglutide). The study also integrated laboratory markers in their assessments.
The research suggested that as use of GLP-1 drugs soars around the world, researchers in the medical community will develop innovative testing approaches for intrapatient analysis. This study, however, focused on computed tomography (CT) imaging and CT-based artificial intelligence (AI) tools.
FDA issues warning for Cue Health COVID-19 tests
Prompted by a lab inspection, in early May the U.S. Food and Drug Administration (FDA) issued a warning letter about the risk of false-positives with Cue Health's COVID-19 over-the-counter test and its COVID-19 test intended for point-of-care settings.
Cue made changes to the tests without authorization, according to the FDA. Cue later ceased operations, laid off its staff, and filed for bankruptcy. Later in the year, the FDA issued a Class II recall of the two COVID-19 tests, just in case any were still hanging around.
FDA took issue with the quality, analytical, and clinical performance claimed in the authorized labeling.
Reading blood-oxygen saturation levels on a smartphone
Popular again this year is a smartphone camera oximetry study out of the University of Washington and University of California San Diego.
The study demonstrated a potential alternative for deciphering blood oxygen levels using the camera and flash of a smartphone instead of a traditional pulse oximeter.
Healthy people always have at least 95% oxygen saturation. However, when the researchers delivered a controlled mixture of nitrogen and oxygen to six subjects to artificially bring their blood oxygen levels down, the smartphone correctly predicted whether the subject had low blood oxygen levels 80% of the time, according to the research originally published in September 2022.
Seems to be crickets since.
Clinical laboratory testing implicated in national healthcare fraud sting
Healthcare fraud enforcement was in full force across the land, as noted by this mid-year report highlighting $2.75 billion in fraud, some of which involved clinical laboratory affairs.
Trouble brewed mainly along four types of clinical laboratory tests: COVID-19 testing, cancer genetic testing, cardiovascular genetic testing, and pharmacogenetic (PGx) testing.
Charges ranged from conspiracy to commit healthcare fraud, conspiracy to violate the U.S. federal Anti-Kickback Statute (AKS), and paying and receiving healthcare kickbacks, to money laundering, and more.
Humana, UnitedHealthcare change Z-Code requirements for molecular diagnostic test claims
Z-Codes piqued the interest of the LabPulse.com community in September when both Humana and UnitedHealthcare (UHC) updated their Z-Code requirements for molecular diagnostic test claims.
Select national Medicare Advantage (MA) payers have begun participating in Medicare Administrative Contractor Palmetto GBA's Diagnostic Exchange (DEX). Among the tests in focus are certain RNA- and DNA-based tests, and certain MA Current Procedural Terminology (CPT) codes.
Z-Codes have emerged as a standard used by health plans, but it takes some work to get them. Clinical and molecular diagnostic laboratories that do not have a Z-Code for their test must determine if the test requires submission to the DEX Registry based on the current list of CPT codes.
VA to offer no-cost pharmacogenomic testing program
A pilot program offering no-cost pharmacogenomic (PGx) testing to veterans in the U.S. quickly rose to one of LabPulse.com's top stories in 2024.
Published December 5, the story describes a new initiative at the U.S. Department of Veterans Affairs (VA), starting with Veterans Integrated Service Network (VISN) 4 which encompasses Pennsylvania, Delaware, and parts of New Jersey, Ohio, and West Virginia. The initiative involves a one-time PGx blood test designed to analyze 16 genes.
The VA said the program is part of clinical care, not a research study, and its PGx team will hold monthly PGx patient education meetings online. PGx, the VA said, can be used to inform patients and healthcare providers on medication and dosage selection, as well as potential side effects.
Gilead announces impending layoffs, facility closure
With its third-quarter revenue reportedly the strongest of the year to date, Gilead Sciences in November was proceeding with plans to lay off staff at its California Bay Area headquarters and an office in Seattle, as well as close the Philadelphia facility of its subsidiary Kite Pharma.
Gilead produces several successful HIV therapies, including Biktarvy and Truvada, the COVID-19 therapy Veklury (remdesivir), as well as the chimeric antigen receptor T-cell immunotherapies Tecartus (brexucabtagene autoleucel) and Yescarta (axicabtagene ciloleucel).
On a new note dated December 17, Gilead announced breakthrough therapy designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy.
The company also made a $20.1 million equity investment in Assembly Biosciences to support antiviral therapeutic candidates, and it announced a new chief medical officer in December, Dr. Dietmar Berger, PhD, who has held previous roles at Sanofi, Atara, Genentech, Bayer, and Amgen.
Cepheid lays off over 600 employees in Calif.
In September, Cepheid was also proceeding with a layoff. The downsizing affected roughly 13% of the company's workforce, mostly manufacturing jobs in Sunnyvale, CA, and logistics jobs in Fremont, CA.
Cepheid, a Danaher company, produces cartridge-based diagnostics, primarily for infectious diseases. Its Xpert HCV test for the hepatitis C virus (HCV), along with the GeneXpert Xpress System, was granted de novo marketing authorization and a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver by the FDA in late June.
Since then, Cepheid has announced a partnership with the Fleming Initiative of the Imperial College Healthcare National Health Service Trust and Imperial College London to combat antimicrobial resistance (AMR). Cepheid plans to use its in vitro diagnostics products to support antimicrobial stewardship programs for responsible antibiotic use and control the rise of resistant infections, starting with active screening for carbapenemase-producing Enterobacteriaceae (CPE).
Another development in December involves World Health Organization (WHO) prequalification of Cepheid’s molecular diagnostic tuberculosis (TB) test, Xpert MTB/RIF Ultra.
Lab manager, employees, sales reps on hook in $7.2M whistleblower fraud case
Here's an example of how even a complex patchwork of fraud schemes won't outwit Medicare, Kentucky Medicaid, and Tricare watchdogs for too long.
In a whistleblower case over two years of laboratory testing for recovery centers and homeless shelters, a hospital and collaborating laboratory employees, sales reps, and even a specimen collector agreed to $7.2 million in settlements.
Those implicated entered settlement agreements to resolve their False Claims Act liability for causing a hospital's submission of false claims for laboratory tests from nonmedical entities, tests that were not medically necessary or were tainted by violations of the Anti-Kickback Statute (AKS).
Invitae delisted on NYSE, trading suspended
In February, the LabPulse.com community took note of genetic testing developer Invitae’s stock plunge to a precipitous low. The fall prompted the New York Stock Exchange (NYSE) to suspend trading of Invitae stock and begin the delisting process.
Before trading of Invitae stock was suspended, its price had plummeted to less than 10¢ per share. The San Francisco-based medical genetics company had previously received a notice of noncompliance from the NYSE in September 2023 after its stock price closed under $1.00 per share for 30 consecutive days.
Invitae would later fall into bankruptcy and a court-supervised auction with Labcorp the winning bidder, pledging $239 million in cash consideration with other noncash consideration.
