5 Clinical Laboratories Leading the Way in Patient Care

Research advancements and regulatory changes are rapidly altering the landscape of diagnostic testing and disease treatment—and clinical labs are seizing the opportunity to blaze new trails in patient care. From better brain diagnostics to easier cancer monitoring, early adopters are crucial contributors to the widespread acceptance and use of new tests, guidelines, and interventions. 

Here, we round up five exciting “firsts” paving the way for faster testing, more reliable results, and better outcomes for patients and providers.

First hospital performing blood tests for concussion

In April 2024, the FDA approved the first rapid blood test for traumatic brain injury (TBI), including concussion. Now, Orlando Regional Medical Center (ORMC) in Florida has become the world’s first hospital using that test to evaluate patients with suspected mild TBIs. 

The test uses Abbott’s proprietary i-STAT Alinity System with a dedicated TBI cartridge to measure circulating levels of ubiquitin C-terminal hydrolase L1 and glial fibrillary acidic protein, biomarkers commonly elevated in TBIs. Because time is of the essence when diagnosing and treating these injuries, the i-STAT TBI test returns results in 15 minutes and is performed on a handheld device that can be used at the point of care or even in the field. 

This will allow ORMC to rapidly triage the approximately 1,500 TBI patients it sees each year—quickly identifying those who need imaging or treatment and preventing unnecessary interventions in those who don’t.

“Now, doctors are finally armed with a blood test to check your brain,” said Linda Papa, MD, MSc, CCFP, FRCP(C), FACEP, director of academic clinical research at Orlando Health, in a press release. “This is a game-changer, and we are just getting started.”

First use of blood-based biomarkers for dementia

Alzheimer’s disease diagnosis is based primarily on clinical presentation, with imaging and laboratory testing largely reserved for ruling out other conditions with similar signs and symptoms. However, this clinical approach leaves the door open to diagnostic errors and delays, meaning that patients may miss opportunities for lifestyle interventions or disease-modifying treatments, both of which are most effective in the early stages of the disease. 

To accelerate early detection and increase diagnostic accuracy, New York’s Mount Sinai Health System has become the first in the northeastern US—and one of the first in the world—to implement blood-based biomarker testing for Alzheimer’s disease and related dementias. 

The tests will examine circulating levels of three proteins: p-tau 217, neurofilament light chain, and glial fibrillary acidic protein. The first is a known biomarker for Alzheimer’s disease, including at the preclinical stage; the latter two are biomarkers of neuronal inflammation and damage and are frequently elevated in early dementia.

“This project is critical for providing noninvasive, low-cost testing options and improving how we diagnose and treat these disorders,” Fanny Elahi, MD, PhD, project co-leader and director of fluid biomarker research at Mount Sinai’s Barbara and Maurice Deane Center for Wellness and Cognitive Health, said in a statement. “What we’re measuring today is just a tip of the iceberg of so much more to come.”

First Canadian hospital offering in-house liquid biopsy

With the global cancer burden growing rapidly and survival rates frequently dependent on stage at diagnosis, short turnaround times and reliable results are vital. That’s why William Osler Health System in Ontario, Canada, recently became the first hospital in Canada to offer in-house liquid biopsy for cancer diagnosis, monitoring, and treatment selection. 

The move’s value is supported by a three-year retrospective study in which Osler’s lab at Brampton Civic Hospital, a full-service community teaching hospital serving more than half a million people, provided liquid biopsy testing to 124 patients on clinician request. 

The results? A median turnaround time of three days, with 14 percent of results reported within 24 hours. Overall sensitivity was lower than that of tissue biopsy at 71 percent, suggesting that the technique requires further improvements to replace, rather than supplement, tissue testing. 

Nonetheless, a positive diagnosis via liquid biopsy could spare patients the costs, delays, and risks of a more invasive procedure.

First guidance on laboratory diagnosis of respiratory viruses

Since the outbreak of the COVID-19 pandemic, respiratory infections have been at the forefront of people’s minds—and now, with SARS-CoV-2 joining the group of endemic viruses that cause these infections, best practices for diagnostic testing are urgently needed. 

In May 2024, the Association for Diagnostics and Laboratory Medicine (ADLM) released the first-ever formal guidance on respiratory virus testing to support clinical labs in determining whom, when, and how to test. 

The guidance covers 

• patient populations most likely to need testing (those who are hospitalized, immunocompromised, or whose results will affect management), 
• timing (when respiratory infections are likely and the results will change management, infection control, or epidemiological surveillance), 
• specimen type (with nasopharyngeal swabs preferred where possible), methodologies used for virus detection (ideally nucleic acid amplification testing), and 
• recommendations for result interpretation based on test type and clinical presentation.

First clinical trials of lung cancer vaccine

Most people diagnosed with lung cancer have non-small cell lung cancer (NSCLC), a condition whose five-year survival rate rests at just 25 percent. To tackle this devastating disease, the world’s first mRNA vaccine candidate against lung cancer, BioNTech SE’s BNT116, has entered clinical trials in 10 countries across three continents. 

The vaccine encodes six lung cancer-associated antigens common in NSCLC and is intended to spur the recipient’s immune system into combating cells with those markers—potentially offering lasting protection against recurrence. 

The vaccine is currently being tested alone and in combination with cemiplimab or docetaxel in two separate studies: a Phase 1 trial in patients with advanced NSCLC (stage 3/4 unresectable or stage 2/3 resectable tumors), and a Phase 2 trial in patients with advanced NSCLC whose tumors have greater than 50 percent PD-L1 expression.

“We hope adding this additional treatment will stop the cancer coming back because a lot of time for lung cancer patients, even after surgery and radiation, it does come back,” Siow Ming Lee, MB BS, PhD, FRCP, a professor of medical oncology at University College London and one of the trial investigators, recently told press. 

“It’s simple to deliver, and you can select specific antigens in the cancer cell, and then you target them. This technology is the next big phase of cancer treatment.”