Pro-AMP™ enables qualified physician office laboratories to implement rapid, patient-specific infectious disease testing through customizable isothermal workflows.
“Speed is critical, but it’s not the only factor,” Rae stated. “The future of infectious disease diagnostics also needs to be cost-effective, scalable, and straightforward to read in a near-patient environment.”— Robert Rae
Pro-AMP™ is built to help eligible physician office laboratories roll out quick, patient-specific infectious disease testing using configurable isothermal workflows.
Pro-Lab Diagnostics USA today unveiled Pro-AMP™, an isothermal nucleic acid amplification platform aimed at supporting qualified physician office laboratories (POL), specialty practices, and high-complexity CLIA-certified labs that conduct infectious disease molecular testing across a variety of fields, such as urogenital (OB/GYN), respiratory (ENT), wound, and antibiotic resistance gene detection.
Pro-AMP™ is engineered to accommodate flexible workflows that can be tailored to the individual patient, sample type, clinical presentation, ordering clinician, medical necessity, and relevant billing and compliance regulations. Instead of pushing every patient into a single fixed panel format, Pro-AMP™ allows for configurable multi-target (not multi-plex) assay selection, enabling labs to organize testing around clinically significant pathogens, resistance markers, and diagnostic categories.
Physician office laboratories are increasingly looking for faster, more actionable infectious disease testing approaches that can inform clinical decisions closer to the point of care. Pro-AMP™ is intended to help eligible practices and lab partners bring molecular infectious disease testing into more accessible clinical environments while upholding the validation, documentation, and compliance standards necessary for high-complexity laboratory operations.
In contrast to conventional PCR methods that depend on thermal cycling, isothermal amplification allows nucleic acid amplification at a steady temperature. This technique can lower instrument complexity, streamline workflow design, and support faster, more cost-efficient molecular testing approaches. Pro-AMP™ merges this operational simplicity with adjustable target menus, adaptable assay design, and compatibility with automated or semi-automated lab workflows.
“Physician practices require quicker answers without being forced into inflexible, one-size-fits-all testing models,” said Robert Rae, CEO of Pro-Lab Diagnostics USA. “OB/GYN, urology, wound care, primary care, pediatrics, and infectious disease practices all encounter patients whose symptoms overlap across multiple potential pathogens. Pro-AMP™ was created to provide qualified physician office laboratories and high-complexity lab partners with a versatile molecular platform that can support patient-specific infectious disease testing while maintaining the rigor needed for clinical laboratory workflows.”
The need for adaptable molecular diagnostics has increased as providers seek faster turnaround times and more actionable results for clinical decision-making. Respiratory infections, urinary tract infections, sexually transmitted infections, vaginitis, wound infections, gastrointestinal disease, and antimicrobial resistance increasingly demand targeted molecular answers that can guide treatment, triage, isolation decisions, antimicrobial stewardship, and follow-up care.
Pro-AMP™ is meant to serve as the molecular testing component of Pro-Lab Diagnostics USA’s broader laboratory platform, supporting physician office laboratories and testing partners that require practical infectious disease workflows connected to sample collection, lab operations, reporting, inventory management, compliance, and scalable testing initiatives.
Pro-AMP™ is designed to overcome several practical obstacles that have historically restricted broader access to molecular infectious disease testing in physician practice settings:
Patient-specific target selection: Labs can configure testing based on the patient’s symptoms, sample type, clinical history, and suspected infectious disease category.
Configurable multi-target workflows: Target menus can be adjusted without forcing every patient into the same fixed panel structure.
Physician office lab deployment: Workflows are designed to support qualified POLs, specialty practices, and high-complexity lab partners seeking practical molecular testing infrastructure.
Billing and compliance alignment: Workflows can be arranged to support medically necessary testing, appropriate target selection, and lab-specific validation requirements.
Rapid workflow design: Amplification workflows are built for quick turnaround, with lab reporting models that may enable same-day or next-day results depending on sample handling, extraction, validation, staffing, and reporting processes.
Simplified interpretation: Targeted molecular results can reduce ambiguity compared to culture-only or symptom-based approaches.
Scalability: Menus can be adjusted for seasonal demand, outbreak response, specialty testing programs, and emerging pathogens.
Cost efficiency: Isothermal amplification can reduce dependence on complex thermal cycling infrastructure.
Flexible deployment: Panels and target menus can be implemented by qualified high-complexity labs as part of properly validated LDT workflows.
Clinical relevance: Menus can be configured around actionable infectious disease categories, including respiratory disease, women’s health, urinary tract infections, wound infections, gastrointestinal pathogens, sexually transmitted infections, and resistance markers.
The infectious disease testing landscape is evolving rapidly. During respiratory season, clinicians often need to differentiate between pathogens with overlapping symptoms. In women’s health, molecular testing can support more accurate detection of vaginitis, vulvovaginal candidiasis, sexually transmitted infections, and urinary tract infections. In wound care and antimicrobial resistance, faster pathogen and resistance-gene information can help guide appropriate therapy and reduce unnecessary empiric treatment.
“Speed matters, but speed alone is not enough,” Rae added. “The next generation of infectious disease diagnostics must also be affordable, scalable, clinically relevant, and easy for providers to interpret. Pro-AMP™ is our answer to that market need: flexible molecular testing that can be tailored to the patient and brought closer to the physician practice setting.”
Pro-Lab Diagnostics USA intends Pro-AMP™ to support qualified physician office laboratories, specialty practices, healthcare systems, public health programs, and laboratory testing partners seeking a practical molecular platform for infectious disease testing, surveillance, antimicrobial resistance monitoring, and epidemiological research.
About Pro-Lab Diagnostics USA
Pro-Lab Diagnostics USA is a molecular diagnostics and laboratory services company focused on infectious disease testing, laboratory innovation, and applied diagnostic platforms. The company develops and supports testing solutions for physician office laboratories, clinical laboratories, healthcare providers, and public health applications, including molecular testing workflows, laboratory operations tools, sample collection programs, and scalable diagnostic infrastructure.
Regulatory Notice
Pro-AMP™ panels, menus, and workflows are intended for use by qualified laboratories, including properly certified physician office laboratories and high-complexity CLIA-certified laboratories, as part of properly validated laboratory workflows. Availability, performance claims, billing practices, target selection, and clinical use depend on each laboratory’s validation, CLIA certification status, personnel qualifications, applicable payer requirements, applicable state and federal requirements, and intended use. Pro-AMP™ is not presented as a waived, over-the-counter, or home-use test unless separately authorized for that use.
Robert Rae
Pro-Lab Diagnostics
+1 512-832-9145
email us here
