The pain came out of nowhere, hitting Michelle Reeves fast and hard, like a bullet train.

The intense stabbing in her upper abdomen was so severe, Reeves barely had time to administer a self diagnosis before losing consciousness. In the seconds before she surrendered to the void, Reeves—a trained medical technologist—suspected she was having a heart attack.

“I had intense upper abdominal pain, which I interpreted as chest pain. I passed out and hit my head on the edge of the kitchen counter,” Reeves recalled in an online video. “My husband dialed 9-1-1 and I was taken to my hospital. We were both scared because we didn’t know if it was a heart attack.”

Paramedics transported Reeves to the hospital at which she worked, where, in a rare stroke of luck (or serendipitous twist of fate), she was treated by the point-of-care team she once trained. The team employed that training to verify Reeves’ suspicions by using diagnostic tests that measure numerous blood biomarkers.

Those assays ultimately allayed Reeves’ initial fears.

“I knew I was in capable hands. Upon arriving in the E.D., my care team ran i-STAT Chem 8+ and i-STAT Troponin, which quickly advised them I was not having a cardiac issue. With i-STAT, my team was able to rule out any cardiac-related issues, which calmed me down and gave us the comfort that we needed.”

Quick comfort, at that. The i-STAT System from Abbott Laboratories processes point-of-care diagnostic test results within minutes. The i-STAT CHEM 8+’s analytical prowess produces 120-second assessments for sodium, potassium, chloride, ionized calcium, glucose, urea nitrogen, creatine, hematocrit, and hemoglobin levels. 

Abbott’s i-STAT product line also includes a 10-minute cardiac troponin I (cTnI) test for measuring troponin I levels in whole blood or plasma. A myocardium-specific protein, troponin I exists almost exclusively in heart muscle but can seep into the bloodstream upon damage to cardiac cells. Elevated troponin levels can denote a heart attack, and its volume can depict severity—i.e., higher troponin levels imply more severe heart damage.

“With the i-STAT, my care team was able to make treatment decisions quickly and efficiently,” Reeves said. “Many patients in the hospital get their blood tested on the i-STAT and now as a patient and the hospital’s point-of-care supervisor, I have as well. I know the importance of delivering accurate lab quality results fast and the positive impact on the quality of patient care.”

Such an epiphany is becoming more common nowadays as cutting-edge concepts replace convention in the fast-growing in-vitro diagnostic market. The prolonged, laboratory-based, specialized testing techniques that became the norm during the latter part of the 20th century have lost favor to the faster, more accurate, diversified assays demanded by 21st century active seniors.

With a wealth of information at their fingertips, this aging patient population has become increasingly aware of bedside (a.k.a., point-of-care) testing and customized medicine. Demand for these services, along with the mounting importance of companion diagnostics, escalating prevalence of infectious and chronic diseases, and technological advancements, are expected to boost the global in-vitro diagnostics (IVD) market 6.9% annually over the next decade, according to Nova One Advisor data. The sector’s value is forecast to surge 95%, going from $80.85 billion in 2024 to $157.56 billion in 2034, the market research firm predicts.

Comparably robust growth is anticipated for the U.S. IVD market as well. Research and Markets predicts a 52.2% overall jump in sector value through 2033, fueled by enhanced diagnostics solutions and rising demand for early disease detection. The Dublin-based company envisions the market expanding 4.8% annually to reach $65 billion in the next eight years.

“The IVD market is evolving rapidly, driven by a growing demand for faster, more accessible diagnostics,” said John Nino, CEO of Life Science Outsourcing Inc., a Brea, Calif.-based contract manufacturer and value-added service provider to medical device and life sciences companies. “People no longer want to wait days for lab results—they want answers now, whether they’re in a hospital, a doctor’s office, or at home. This shift is fueling the rise of decentralized testing, with point-of-care and molecular diagnostics leading the charge. Point-of-care testing is all about speed and accessibility. People want rapid, accurate results without waiting for centralized labs or multiple visits to a healthcare facility. That’s why we’re seeing a surge in portable, easy-to-use diagnostic devices—some even integrating with smartphones for real-time analysis and seamless reporting to healthcare providers.”

Polish startup Genomtec SA is targeting patients’ and providers’ portability passion with its compact molecular diagnostics platform under development. The company’s flagship product, Genomtec ID, is touted as a “revolutionary” mobile tool for accurately identifying infectious disease pathogens in the shortest time-to-result. Its microfluidic lab-on-a-chip platform is empowered by the firm’s proprietary discovery method—Streamlined Nucleic Acid Amplification Technology (SNAAT), which uses isothermal chemistry and a patented contactless optical heating and detection system for spotting DNA/RNA fragments.

Genomtec ID features an analyzer and reaction card with integrated genetic tests, offering multiplexing capability of up to five genetic targets at once and results within 15-25 minutes. Requiring only a single drop of biologic material, the company boasts its diagnostic platform can be used by healthcare professionals with no laboratory training (doctor, nurse, paramedic, etc.).

“The in-vitro diagnostics market is transforming rapidly and profoundly. The movement toward decentralized testing—enabled by microfluidics, digital health, and connected platforms—is reshaping how and where diagnostics happen,” noted Robert Morin, sales and marketing vice president at Plastic Design Company (PDC), a Scottsdale, Ariz.-headquartered specialty manufacturing firm focused on precision injection molding and value-added assembly for medical device and life sciences customers. “Point-of-care and at-home solutions are gaining traction across clinical applications, from infectious disease to chronic care management. The result is a faster turnaround, improved patient engagement, and reduced burden on centralized labs. This evolution is closely linked to the rise of precision medicine. Once confined mainly to oncology, molecular diagnostics are expanding into pharmacogenomics, chronic conditions, and real-time infectious disease monitoring.”

And soon, prenatal care. Swiss startup MOMM Diagnostics GmbH has devised a rapid point-of-care preeclampsia test for use in hospitals, clinics, or the home. A life-threatening hypertensive disorder affecting pregnant women, preeclampsia and related conditions such as gestational hypertension, HELLP syndrome, and eclampsia are usually characterized by a swift rise in blood pressure that can lead to seizure, stroke, multiple organ failure, and even death of the mother and/or baby. 

MOMM’s preeclampsia test (preXclude) works by identifying and measuring two blood biomarkers commonly associated with preeclampsia risk: anti-angiogenic factor sFlt-1 and placental growth factor PlGF. The molecules are detected in minutes from a single blood drop at a higher specificity and sensitivity than current diagnostics, according to the firm’s CEO and co-founder.

preXclude runs on MOMM’s eFlow system, a diagnostic platform that offers users the sensitivity of lab-based assays at the point of care. The system resembles a pregnancy test, featuring a compact, low-cost reader that requires minimal hands-on time and training, and a tiny biosensor (for biomarker detection) printed on a paper strip. 

Results are analyzed electronically and available for review at the point of care—even if that point is a gynecologist’s office. Unlike conventional testing, preXclude’s blood samples can be evaluated without assistance from a specialized lab, enabling the assay to assess preeclampsia risk at its earliest stage.

“Point-of-care diagnostics are increasingly designed with the end user in mind—whether that’s a clinician or a consumer,” Nino explained. “We’re seeing innovation in disposable, connected devices that can be used at home or in clinics, with results transmitted directly to healthcare professionals for timely intervention.”

Such innovations have materialized at a frenetic pace over the last few years, triggered (not surprisingly) by the COVID-19 pandemic. Before the outbreak, rapid diagnostic testing was conducted mostly by healthcare professionals working in clinics, laboratories, or hospitals. The pandemic, however, forced researchers and innovators to devise universal testing methods that could performed by anyone, anywhere, at any time. 

Those solutions provided much-needed relief to healthcare systems stretched beyond capacity (and in some cases, capability) but they also helped galvanize a paradigm shift to greater patient access and care engagement. The pandemic prompted folks to take ownership of their healthcare, which in turn, induced demand for novel, patient-led diagnostic and delivery methods.

“The vast majority of the population knows what PCR tests or rapid antigen assays are. Many have tested themselves using rapid antigen tests acquired in a pharmacy through free programs implemented by the federal government or self-collected a specimen in the home to send back to a laboratory,” noted Subho Goswami, director of Strategy and Global Marketing at Porex Corporation, an advanced porous solutions provider, and Oasis Diagnostics CEO Paul Slowey, special advisor to Porex. “At the beginning of the pandemic most diagnostic testing was performed using either nasopharyngeal or oropharyngeal specimens. In March 2020 a worldwide shortage of swab materials caused multiple organizations to adopt saliva specimens as a preferred sample matrix. Over 30 saliva tests for COVID-19 were approved through the FDA’s Emergency Use Authorization route. This has led to a much greater interest in oral fluids for the diagnosis of multiple diseases including cancers, Alzheimer’s disease, dental caries, periodontitis, HIV, and many others.”

Oasis Diagnostics first recognized that interest more than two decades ago and has been working since then to address the growing need for non-invasive saliva-based technology for rapid testing, sample collection, and molecular diagnostics. The Vancouver, Wash.-based company’s oral fluid product family comprises a split sample saliva/oral fluid collection device (Versi-SAL), a salivary DNA collection tool (DNA-SAL), a universal saliva collection device (Super•SAL), a product for RNA and/or protein collection for genomic applications or proteomics (RNAPro•SAL), and an oral fluid rapid test platform (VerOFy). 

The latter solution combines rapid and standardized saliva (oral fluid) collection with high-quality immunochromatographic test strips for delivering immediate results at the point of care. VerOFy aims to assess biomarker levels and multiple diseases or disease states in any setting where immediate results from saliva samples are required. Specific applications under development include saliva tests for cortisol, testosterone, and a multiplex assay for detecting multiple hormone biomarkers. Future tests include salivary biomarker assays for Alzheimer’s disease, Parkinson’s disease, sleep disorders, and anti-malarian hormone (AMH). 

“From a technology perspective, there is an ever-increasing need to derive more clinical information from smaller and smaller sample volumes. This is especially true in the area of multiplex testing for a series of biomarkers from one sample that is split into several fractions,” Goswami and Slowey told MPO. “Material technologies have been at the forefront of providing access to purer fractions of nucleic acids through continuous innovation. ReadyGo and Porex’s partnership, for instance, has seen the introduction of a Sampler device that uses proprietary chemistries lyse cells of interest from collected clinical samples on a swab. Adding Porex’s filtration capabilities at the point of sample dispensation ensures very pure nucleic acids are being used for downstream testing, allowing for access to more clinical insights from very small sample fractions.”

Multiplex testing has gained considerable market traction in the pandemic’s wake as waning coronavirus assay demand inspired all-in-one respiratory virus solutions. Diagnostics manufacturers that specialized in COVID-19 detection kits have since pivoted to develop PRC assays for differentiating SARS-CoV-2, influenza A & B, and RSV from a single sample.

Labcorp and BD, for example, now market test kits that detect COVID-19, Flu A, Flu B, and respiratory syncytial virus, while Lucira Health Inc. and Visby Medical similarly sell assays for simultaneous coronavirus and flu screening.

Lucira’s COVID-19/flu and COVID-19 assays are nucleic acid amplification tests with sensitivity and specificity comparable to lab-based PCR (polymerase chain reaction) techniques. Producing results in 30 minutes, the tests run on a palm-sized device without separate instruments or readers.  

Lucira’s COVID-19 test is available in the United States, Canada, Singapore, Israel, and Taiwan. The COVID-19/flu assay uses the same platform and palm-sized device design as the coronavirus test and screens for SARS-CoV-2, Flu A, and Flu B from a single nasal swab, and provides results in less than 30 minutes.  

Visby Medical’s handheld PCR test also differentiates between Flu A, Flu B, and COVID-19, and like Lucira’s assay, offers results in less than 30 minutes. Granted U.S. Food and Drug Administration (FDA) clearance and a CLIA waiver in February, the test is the first handheld assay to receive such a designation after winning Emergency Use Authorization (EUA) in December 2022.

“COVID-related testing led to historically high sales for many organizations in the IVD space. For example, think about how many COVID-19 test kits were distributed to help prevent further spread of the disease,” stated Brendan Simmonds, IVD product manager at Arden Hills, Minn.-headquartered CPC (Colder Products Company), which provides quick disconnect couplings, fittings, and connectors in a wide variety of markets including life sciences and bioprocessing. “After the pandemic surges, there was the pent-up demand for healthcare that had been deferred due to COVID. Now we’re starting to see a renewed emphasis on early detection of a broad range of non-COVID diseases worldwide.” 

Those diseases range from cancer and HIV to Alzheimer’s and Parkinson’s disease. HIV tests, for instance, are offered by Abbott, Hologic Inc., Grifols, OraSure Technologies Inc., Roche, Siemens, and Cepheid, among others. Cepheid’s Xpert HIV-1 Qual XC earned World Health Organization (WHO) pre-qualification status last spring, meaning it meets WHO-defined global quality safety, and efficacy standards. The in-vitro amplification test qualitatively detects HIV-1 total nucleic acids directly from human dried blood spots and capillary or venous whole blood specimens. 

Xpert HIV-1 Qual XC provides extended strain coverage by including two gene targets to identify HIV-1 infections, delivering results up to seven to 10 days before seroconversion. The test has been cleared for use in the early diagnosis of infants, adolescents, and adults at the point of care and in laboratories.

“As our understanding of disease at the molecular level deepens, diagnostic testing is becoming more essential to delivering personalized, effective treatments,” Nino declared. “This shift is fueling rapid expansion in technologies like next-generation sequencing, polymerase chain reaction, and companion diagnostics, which help match patients with the therapies most likely to benefit them.”

Those technologies have spawned a spate of diagnostic cancer assays (for leukemia, non-small cell lung cancer, ovarian, colorectal, breast, and pancreatic malignancies), and more recently, Alzheimer’s disease blood tests.

Various laboratory-developed tests for Alzheimer’s blood biomarker p-Tau 217 are currently available and used in research and select specialty clinical care centers in the United States and Europe. 

ALZpath Inc.’s p-Tau 217 antibody is integral to multiple advanced blood tests, including assays being developed for clinical use by Roche and Beckman Coulter, and diagnostics used in research from Bio-Techne, Alamar Biosciences, and Quanterix. Notably, Roche and Beckman Coulter’s p-Tau 217 assays have received FDA breakthrough device designation by the FDA.

Last fall, Advance Tests launched a multi-marker Alzheimer’s disease blood test in the United Kingdom. Developed by Lucent Diagnostics (a Quanterix Corporation commercial brand), the assay combines several Alzheimer’s-related biomarkers, including p-Tau 217, to improve early detection in patients with cognitive symptoms.

The LucentAD Complete test uses p-Tau 217 and additional biomarkers—Aß42/40, GFAP, and NfL—to improve amyloid detection over single biomarker tests, delivering definitive amyloid pathology results for roughly 90% of cases. The test meets the Global CEO Initiative on Alzheimer’s Disease’s and the U.S. Alzheimer’s Association performance standards for plasma-based diagnostic tools, offering an advanced alternative to the current gold standard cerebrospinal fluid (CSF) or PET imaging approaches that are both highly invasive and considerably more expensive.

Labcorp bolstered its Alzheimer’s disease test market profile in early April by launching its new blood-based biomarker test in the United States. The p-Tau 217/Beta Amyloid 42 Ratio is being touted as a first of its kind immunoassay that measures two distinct biomarkers that indicate the presence of Alzheimer’s disease—p-Tau 217 and Beta Amyloid 42—in ratio. The test offers a 95% sensitivity and specificity, which is substantially equivalent to PET imaging and CSF testing. 

“The use of novel screening and detection platforms capable of identifying single molecules is revolutionizing biomarker discovery and clinical diagnostics,” said Russ Lebovitz, co-founder/CEO of Amprion, a San Diego-based developer of seed amplification assays. “Technologies such as amplification-proteomics, high-throughput DNA/RNA analysis, and clinical mass spectrometry enable more precise and early detection of disease-related biomarkers.”        

Amprion catches the early warning signs of neurodegenerative disease through its seed amplification assays (SAA).

The company’s SAAmplify-ɑ SYN (CSF) test is a laboratory-based assay that can help detect synucleinopathies, including Parkinson’s disease, Lewy body dementia, multiple system atrophy (MSA), and Alzheimer’s + DLB. The test identifies the presence of alpha-synuclein pathology several years before overt clinical features of Parkinson’s, Lewy body dementia, or MSA appear, thus enabling clinicians to provide an early diagnosis and differentiate the conditions from other diseases such as Alzheimer’s, frontotemporal dementia, and progressive supranuclear palsy. Offering a 96% sensitivity and 92% specificity, in detecting ɑ-synuclein pathology, Amprion’s SAA technique reportedly is the only seed amplification assay commercially available to detect synucleinopathies in CSF.

“There is a growing consensus that most diseases arise from specific molecular changes, which can be detected in real time using various molecular technologies,” Lebovitz stated. “Advances in enhanced immunoassays, nucleic acid chemistry, mass spectrometry, protein amplification, and advanced microscopic imaging contribute to this shift. In parallel, the continued evolution of single-molecule detection and AI/ML-driven data analysis is accelerating the adoption and refinement of these diagnostic tools.”

Indeed, artificial intelligence (AI) and machine learning (ML) are transforming in-vitro diagnostic performance and outcomes. AI-driven IVD platforms have proven more effective at biomarker analysis than conventional methods and can help detect diseases at their earliest stages., even before symptoms appear.

In DNA and RNA sequencing, AI technology is improving overall efficiency and precision, enhancing complex genomic data interpretation and facilitating personalized medicine via early diagnoses of genetic disorders. Case in point: AI outperforms human intelligence in analyzing genetic markers for breast cancer-linked BRCA mutations, thus allowing for targeted treatments or preventative measures.  

Machine learning is fueling the rise of personalized medicine as well by enabling IVD tools to individualize diagnostic results based on patients’ genetic makeup, lifestyle, and medical history. AI can review and evaluate genetic data to predict patient responses to specific medications or therapies, thereby devising personalized treatments for such common conditions as diabetes, cancer, or cardiovascular disease.

GRAIL Inc.’s Galleri test, for instance, screens for a unique cancer “fingerprint” from DNA fragments shed from cancer cells, according to the company. Validated by rigorous clinical studies, the Galleri assay detects abnormalities in the methylation patterns of cell-free DNA (cfDNA) that could indicate the presence of cancer.

The Galleri test screens for a signal shared by more than 50 cancer types, most lacking recommended screening tests. In a clinical study with a shared cancer signal, adding the Galleri test to recommended single-cancer screening roughly doubled the number of malignancies detected compared with recommended screening alone, study data show.

In February, the company and Quest Diagnostics initiated a program to improve provider access to GRAIL’s Galleri multi-cancer early detection (MCED) test. Providers can now order the Galleri test directly from GRAIL through the Quest Diagnostics connectivity system.

“Artificial intelligence is quietly becoming the connective tissue of modern IVD platforms,” Morin noted. “While traditionally focused on image analysis, AI extends its reach into test interpretation, workflow automation, and quality assurance. From automated slide review in pathology to sample triage in emergency departments, AI is accelerating insight at the point of care. The next frontier? AI is used to process results and optimize diagnostic strategy, reduce error rates, and enhance clinical decision support.” 

Here’s to that next frontier.