Digital Pathology Image Capture Platform
FDA-cleared for HER2, ER, PR, and Ki67
The GenASIs HiPath image capture and analysis platform from Applied Spectral Imaging, Carlsbad, Calif, is a computer-aided evaluation system for immunohistochemistry and CISH assays that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology. Recently FDA-cleared, the platform is intended for use as an aid to pathologists in the quantitative analysis and scoring of HER2, estrogen receptor (SP1), progesterone receptor, and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue. The GenASIs HiPath provides accurate, repeatable, and standardized analysis using a simple three-step process. The platform integrates seamlessly with LIS and enables users to view, analyze, and sign out cases from any location using secure remote access.
Applied Spectral Imaging
(800) 611-3466; www.spectral-imaging.com
Inflammatory Bowel Disease Assay
Differentiate IBD and IBS
Quanta Lite Calprotectin, a new FDA-cleared assay from Inova Diagnostics Inc, San Diego, aids in the diagnosis of inflammatory bowel disease (IBD). In conjunction with other laboratory and clinical findings, the test can also help differentiate IBD from irritable bowel syndrome (IBS). The quantitative, enzyme-linked immunosorbent assay detects calprotectin levels in stool, which can provide critical information to physicians determining the appropriate care of patients suffering from gastrointestinal disorders. Accurate screening of gastrointestinal disorders can reduce unnecessary procedures and healthcare costs.
Inova Diagnostics Inc
(800) 545-9495; www.inovadx.com
Molecular Diagnostics System
Reagent menu under development
The Veris MDx system from Beckman Coulter Diagnostics, Brea, Calif, is a fully automated random access molecular diagnostics system for the quantitative and qualitative analysis of molecular targets from clinical patient specimens. The system integrates key steps in molecular diagnostics to streamline workflow and system management. By providing continuous access, one-step loading and individual test reporting, Veris provides increased control and helps optimize the molecular diagnostics lab. Beckman Coulter recently partnered with Seegene Inc, a multiplex PCR technology developer based in Seoul, Republic of Korea, to manufacture reagents designed exclusively for Veris. The system has received the CE mark, permitting market entry in Europe. It is still in development for the United States, and is not yet available for in vitro diagnostic use in US markets.
Beckman Coulter Diagnostics
(800) 526-3821; www.beckmancoulter.com
Heart Attack Assay
Detection within 30 minutes
The H-FABP test from Randox Laboratories, Kearneysville, WVa, is a laboratory-based clinical chemistry assay suitable for fully quantitative measurement of heart-type fatty acid binding protein (H-FABP) in serum and plasma. H-FABP is a biomarker of myocardial ischemia released during the early stages of a heart attack and is detectable as early as 30 minutes from chest pain onset. Detection of the protein can facilitate the earlier management of patients with suspected acute coronary syndrome, alongside Troponin (TnT or TnI). The assay can be used on a wide range of manufacturers’ clinical chemistry analyzers and does not need any dedicated equipment or software.
Randox Laboratories
(866) 472-6369; www.randox.com
Infectious Disease Testing Platform
Improves the current standard of care
The Iridica diagnostic platform from Abbott, Abbott Park, Ill, can identify more than 1,000 infection-causing pathogens in less than 6 hours, improving upon the current standard of care (culture-based testing), which can take days. By identifying sooner the cause of infections—such as bacteria, viruses, or fungi—doctors can improve care for the critically ill. Iridica uses a combination of polymerase chain reaction and electrospray ionization mass spectrometry to rapidly identify infection-causing pathogens directly from a patient’s sample, without the need for culture. Iridica currently offers five testing panels for pathogens that cause infections in the critically ill, such as sepsis; other bacterial, fungal, and viral infections; and ventilator-associated pneumonia. The platform is now available in Europe and other countries recognizing CE-mark certification as authorization for market entry.
Abbott
(800) 553-7042; www.abbott.com
HIV-1/HIV-2 Assay
Three-step process produces results in 30 minutes
The Geenius HIV-1/HIV-2 supplemental assay from Bio-Rad Laboratories, Hercules, Calif, can differentiate circulating antibodies to human immunodeficiency virus (HIV) types 1 and 2 in whole blood, serum, and plasma. A faster and easier alternative to western blot and an objective alternative to the company’s Multispot HIV-1/HIV-2 rapid test, the assay offers a three-step procedure that produces clear, on-screen results in 30 minutes with full traceability. The reader analyzes and interprets reaction results for HIV-1 (p31 HIV-1 polymerase peptide, gp160 HIV-1 recombinant protein envelope, p24 HIV-1 recombinant protein core, and gp41 Group M and O HIV-1 peptide envelope) and for HIV-2 (gp 36 and gp 140 HIV-2 peptide envelope).
Bio-Rad Laboratories
(510) 724-7000; www.bio-rad.com
Influenza Molecular Test
Differentiate Flu A and B in 15 minutes
The Alere i Influenza A & B test from Alere, Waltham, Mass, is the first molecular test to receive a Clinical Laboratory Improvement Amendments waiver from FDA, permitting the test’s broad use in hospitals, physicians’ offices, clinics, and other healthcare settings. Cleared by FDA in June 2014, the assay is the only molecular test to detect and differentiate influenza A and B virus in less than 15 minutes. In contrast to polymerase chain reaction testing, Alere’s proprietary molecular isothermal nucleic acid amplification technology avoids using time-consuming, complex thermocycling or DNA purification, enabling the test to deliver results more quickly. Influenza generates an estimated 25 to 50 million cases annually. Rapid diagnosis can improve treatment decisions, reduce hospital stays, and prevent the ineffectual prescribing of antibiotics and antiviral medications.
Alere
(781) 647-3900; www.alere.com
Acute Kidney Injury Test
Identifies patients at imminent risk of developing severe AKI
The NephroCheck test system from Ortho-Clinical Diagnostics, Raritan, NJ, is the first-of-its-kind test to receive FDA approval for assessment of acute kidney injury (AKI). AKI is a common and potentially fatal condition in which the kidneys suddenly cease to function as a result of sepsis, pneumonia, major or cardiac surgery, or drugs toxic to the kidneys. The condition generally lacks any signs or symptoms and, if left untreated, may cause irreversible kidney damage. The NephroCheck system detects the presence of insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases in the urine, which are associated with AKI, and within 20 minutes generates a patient risk score. Patients with a NephroCheck AKIRisk score greater than the cutoff of 0.3 have a 25% to 33% chance of developing moderate or severe AKI within 12 hours of assessment.
Ortho-Clinical Diagnostics
(800) 828-6316; www.orthoclinical.com/en-us
Diagnostic Test Platform
Results within 5 minutes
Currently in development, the point-of-decision Micro Lab from Ativa Medical, St Paul, Minn, will run a complete blood count and eventually be capable of performing 90% of the top 30 medical diagnostic tests, including hematology and clinical chemistry tests. The multimode platform is composed of an analyzer, reagent pack, and disposable test card that will deliver results in less than 5 minutes to support treatment decisions. Designed for use by non-technical medical staff in lower-volume primary care test sites, the system involves an easy three-step operation. Users simply scan patient information, load the blood sample, and insert the test card. All sample and test waste is contained within the disposable test card, eliminating system carryover and contamination.
Ativa Medical
(612) 293-3993; www.ativamed.com
Pathogen Detection Service
Fewer false positives
The Absolute-NGS pathogen detection service from Aperiomics, Ashburn, Va, simultaneously tests for all pathogens using an unbiased sequencing and genomic analysis approach. Combining high-throughput next-generation sequencing and advanced Bayesian statistics, the technology produces faster and more accurate results than culture-based methods or other molecular-based approaches. The range of samples can include tissue, blood, plant, animal, or environmental. Absolute-ID is designed to identify known pathogens in virtually any sample, while Absolute-Discovery detects new pathogens that may be contributing to disease. Absolute-Biome is designed to identify all microorganisms present in a given sample. Aperiomics currently provides this technology as a service, receiving samples or sequence data from clients and providing comprehensive data analysis reporting.
Aperiomics
(434) 293-2960; www.aperiomics.com
