Lab-developed tests, lab consolidation and infectious disease threats dominated the news relative to in vitro diagnostic (IVD) companies in 2024, Eye On IVD notes. Other stories, such as rising fungal infections and studies have not been as but are just as important. These stories have been covered by our Linked In newsletter and our email (subscribe at eye on IVD.com).
Eye On IVD notes the following stories:
- FDA’s New Lab-Developed Test (LDT) Policy
- First Over-the-Counter Syphilis Test
- New Lab Acquisitions and Push Towards Consolidation
- Roche Buys LumiraDX for $350M
- Abbott Launches iStat Traumatic Brain Injury Test
- Dramatic Rise in Fungal Infections
- Bird Flu Scare
- Biomerieux Release CLIA-Waived Syndromic Panel
TOP STORY: FDA Lab-Developed Test Policy
It should be no surprise that the top story of 2024 in the laboratory industry, spilling over into the IVD supplier industry, is the FDA’s change in approach regarding lab-developed tests (LDTs). In May 2024, the U.S. Food and Drug Administration (FDA) issued a final rule to regulate laboratory-developed tests (LDTs) as medical devices, aiming to enhance oversight of diagnostics developed and used within individual laboratories. This move marked a significant shift from the FDA’s previous policy of enforcement discretion toward LDTs.
The new regulation mandates that laboratories developing these tests comply with medical device requirements, including premarket review and adverse event reporting, to ensure the safety and effectiveness of LDTs.
According to the ADLM, 48% of laboratories they surveyed may discontinue lab-developed tests as a result of the policy. LDTs may seem, at first glance, like an issue limited to the laboratory market. But there are at least four reasons it matters to makers of test products
“LDTs may seem, at first glance, like an issue limited to the laboratory market. But there are at least four reasons it matters to makers of test products”
-Some IVD companies sell reagents and other supplies for labs performing lab-developed tests
-IVD companies are involved in LDTs directly
-LDT regulations may have customers looking to IVDs for increased support.
-Unkown impact on laboratory market will cause unknown impact on the suppliers.
Eye On IVD fist covered the reaction at Dark Daily’s Executive War College (www.darkdaily.com), a meeting of hundreds of laboratory managers and technicians in New Orleans in April, which coincided with the announcement.
The FDA’s decision has sparked considerable debate and legal challenges. The American Clinical Laboratory Association (ACLA) filed a lawsuit in the U.S. District Court for the Eastern District of Texas, asserting that the FDA exceeded its statutory authority and acted arbitrarily in issuing the rule. Similarly, the Association for Molecular Pathology (AMP) filed a lawsuit in the Southern District of Texas, contending that the regulation imposes unreasonable restrictions and compliance costs on laboratories, potentially delaying critical disease diagnoses and negatively impacting patient care.
The College of American Pathologists (CAP) described the FDA’s actions as “arbitrary and capricious,” emphasizing the potential negative consequences on diagnostic innovation and patient access to essential medical procedures. (https://eyeonivd.com/a-failure-to-come-to-grips-cap-amicus-brief-faults-fda-in-lab-develop-tests-regulation-also-sepsis-news-new-b12-test/)
STORY TO WATCH: FDA Authorizes First At-Home Syphilis Test
The U.S. Food and Drug Administration (FDA) has granted marketing authorization for NOWDiagnostics, Inc.’s (NOWDx) First To Know® Syphilis Test, the first rapid, over-the-counter (OTC) test for syphilis in the U.S. This milestone highlights the advancements in home testing, offering users results in 15 minutes with just a single drop of blood. Eye On IVD suggests this could encourage other companies to innovate in the growing at-home diagnostics market.
Authorized through the FDA’s de novo pathway, the test showed high accuracy in a clinical study of 1,270 participants, with a 99.5% Negative Percent Agreement (NPA) and 93.4% Positive Percent Agreement (PPA). This innovation comes as syphilis cases surge in the U.S., increasing by 80% between 2018 and 2022, including a tenfold rise in congenital syphilis cases among newborns since 2012.
Founded in 2013, Springdale, Arkansas-based NOWDx specializes in OTC and point-of-care diagnostic tests. With over 75 patents, the company aims to make healthcare more accessible and affordable through rapid, reliable in-home testing solutions.
BIGGEST BUY: Roche Acquired LumiraDx Point-of-Care Technologies in $295M Deal
Roche Diagnostics in the #1 in vitro diagnostics provider and excels in centralized instrumentation. That’s why this move into decentralized technology is significant: Roche announced the acquisition of certain point-of-care technologies from LumiraDx in a $295 million deal, with an additional $55 million provided to fund operations until the transaction closed in mid-2024. The acquisition fully integrated LumiraDx’s technology into Roche Diagnostics, bolstering its capabilities in decentralized healthcare testing.
The LumiraDx platform included a suite of immunoassay and clinical chemistry tests, designed to deliver quick and accurate results across various disease areas. Roche Diagnostics CEO Matt Sause described the platform as “highly versatile” and highlighted its potential to improve patient access to timely diagnostics in decentralized settings.
LumiraDx’s regulatory-cleared assays included tests for cardiovascular diseases, HbA1c, C-reactive protein, and COVID-19. The company also received funding from the Bill & Melinda Gates Foundation to develop a molecular tuberculosis test.
This acquisition underscored Roche’s commitment to advancing point-of-care diagnostics and expanding its presence in global healthcare markets.
IVD STORY WITH LAYPERSON REACH: Bird Flu
In 2024, the U.S. faced increasing concern over the potential for avian influenza (bird flu) to evolve into a virus capable of efficient human-to-human transmission. More than 60 people were infected, primarily through exposure to cows or poultry, and one person in Louisiana was critically ill. Health experts warned that just a few mutations could enable the virus to spread widely among humans, posing a significant public health risk.
For in vitro diagnostics (IVD) manufacturers, this situation presented opportunities to develop bird flu detection assays and respiratory assays for rule-out purposes. With the potential for a human outbreak looming, demand for rapid and reliable diagnostic tools was expected to grow.
“Each infection is like pulling a slot machine lever,” one expert noted in media reports, emphasizing how mutations within infected hosts could create a virus capable of widespread transmission.
OFF THE RADAR, BUT IMPORTANT: Fungal Infections Surge: 64% Increase in C. Auris Cases Sparks Concern
The United States saw a dramatic 64% rise in clinical cases of Candida auris (C. auris) in 2023, with 4,514 reported cases compared to 2,928 in 2022. This marks a continued upward trend since the first U.S. case was identified in 2016, underscoring growing concerns about this multidrug-resistant fungal infection.
C. auris is a serious pathogen that spreads easily in healthcare facilities and poses life-threatening risks, particularly for individuals already critically ill. Unlike other fungal infections, C. auris can resist multiple antifungal treatments, making it a significant challenge for infection control in hospitals and long-term care facilities. While people without underlying health conditions or risk factors are generally not susceptible, outbreaks can escalate rapidly without stringent preventive measures.
Healthcare experts emphasize the importance of early detection, patient screening, and rigorous infection prevention protocols to control the spread of C. auris. “Adherence to recommended practices is essential for minimizing outbreaks,” noted one infectious disease specialist.
The surge in cases varied by state, reflecting localized differences in detection and management efforts. The rise in numbers serves as a reminder of the need for robust public health strategies to address the growing threat of fungal infections in healthcare environments. As C. auris continues to spread, vigilance and coordinated efforts are critical to protecting vulnerable populations.
An excellent examination of the topic was had in the May Issue of CAPTODAY: https://www.captodayonline.com/climate-of-concern-over-fungal-infections/
CLIA-Waiver for bioMerieux Sore Throat Test
In 2024, bioMérieux received FDA 510(k) clearance and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel. This multiplex PCR test can detect nucleic acids from up to 15 common bacteria, viruses, and viral subtypes linked to respiratory and sore throat infections, delivering results in about 15 minutes. Samples can be collected via nasopharyngeal or throat swabs depending on the suspected infection.
This marks the third FDA-cleared panel for the BIOFIRE SPOTFIRE System, which also supports the Respiratory (R) Panel and the Respiratory (R) Panel Mini. With the CLIA waiver, these tests can be used by non-laboratory professionals in a wide range of clinical settings, such as urgent care centers, physician offices, and pharmacies.
The R/ST Panel is CE-marked under the In Vitro Diagnostic Directive (IVDD) and is undergoing submission under the In Vitro Diagnostic Regulation (IVDR). bioMérieux also plans to submit the BIOFIRE SPOTFIRE R/ST Panel Mini, designed to detect five common respiratory pathogens, for FDA clearance. The Mini panel is not yet available for sale.
Abbott Nabs Clearance for Traumatic Brain Injury Test
Abbott’s recent FDA 510(k) clearance for its I-Stat TBI cartridge marks a significant advancement in diagnosing traumatic brain injuries (TBIs), which are defined as injuries affecting brain function. The I-Stat TBI cartridge uses whole-blood samples to measure two brain-specific biomarkers, glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase L1 (UCH-L1), which are released into the bloodstream following a head injury. The assay combines biomarkers with an algorithm to provide quantitative results or rule out the need for CT scans, making it suitable for urgent care, nursing homes, and potentially broader applications like pediatric care and concussion diagnostics.
FDA Issues Reclassification Policy, and Makes Good on It
The US Food and Drug Administration said on Wednesday that its Center for Devices and Radiological Health (CDRH) is planning a process to reclassify some high-risk in vitro diagnostics as moderate risk in a move that the agency said would allow manufacturers to seek marketing clearance for their tests through a less stringent regulatory pathway.
According to the FDA, the majority of these high-risk — or Class III — tests are infectious disease and companion diagnostic IVDs. By reclassifying certain of them as moderate risk — or Class II — test makers could obtain clearance through the 510(k) premarket notification pathway rather than the more burdensome premarket approval pathway.
The CDRH will still conduct a premarket review of reclassified tests under the 510(k) pathway, the FDA added. It will also continue to take a risk-based approach in the initial classification of individual IVDs to determine the appropriate level of regulatory controls and whether a new test may be classified into Class II through de novo classification, rather than being Class III and subject to the premarket approval pathway.
In September 2024, the FDA proposed reclassifying antigen, antibody, and nucleic acid-based Hepatitis B Virus assay devices. This initiative is part of the FDA’s broader strategy to ensure that devices are regulated in the appropriate class with the necessary level of regulatory controls, thereby supporting the development of these tests and increasing access to important diagnostic tools.
In addition to the reclassification of certain Hepatitis B Virus (HBV) assay devices, the U.S. Food and Drug Administration (FDA) has initiated the reclassification process for other high-risk tests, including: serology-based IVDs for human parvovirus B19 detection and cell-mediated immune reactivity IVDs for Mycobacterium
CONTINUED LAB CUSTOMER CONSOLIDATION, with Some Big Steps in 2024
There was no letdown in laboratory consolidation in 2024. Several acquisitions. While lab consolidation has been ongoing for years, the economic challenges facing many hospitals and healthcare systems in recent years have further fueled this trend. A steep drop in elective procedures and other services during the COVID-19 pandemic followed by labor shortages and wage inflation cut into profitability. This has led many systems to look to sell off their lab assets to bring in needed cash.
In 2024, major players like Quest Diagnostics and Labcorp took advantage of these conditions, acquiring smaller labs and hospital system lab networks to expand their market share. These acquisitions reflect a continued focus on centralizing operations and cutting costs while securing access to valuable hospital testing contracts.
- LabCorp acquired select parts of BioReference Health’s laboratory business in September of this year. The acquisition includes BioReference Health’s laboratory testing businesses focused on clinical diagnostics and reproductive and women’s health in the United States outside of New York and New Jersey, including certain patient service centers (PSCs), customer contracts and operating assets, which currently generate approximately $100 million in annual revenue. The purchase price for the transaction is $237.5 million.
- In September, Quest acquired select laboratory assets from Allina Health, aiming to improve access to high-quality and affordable laboratory services for providers and patients in Minnesota and western Wisconsin.
- In October, Quest completed the acquisition of select laboratory assets from OhioHealth, broadening access to cost-effective and innovative laboratory services in Ohio
- Quest has acquired 100% of the equity of LifeLabs. Quest expects the transaction to generate approximately CAN $970 million (approximately USD $710 million) in annual revenues. Eye On IVD spoke about this in a G2 Intelligence article: https://www.g2intelligence.com/dx-deals-labcorp-acquires-stake-in-european-testing-giant/
