Envisioning an Essential Diagnostics List (EDL) and Its IVD Market Impact

Envisioning an Essential Diagnostics List (EDL) and Its IVD Market Impact

Kalorama Information offers relevant market research in the areas of molecular point-of-care (POC) diagnostics , traditional POC diagnostics , and physician office laboratory (POL) test markets. Market information in this post was drawn from the associated reports.

In a recent article of the New England Journal of Medicine (NEJM), health and medical experts convincingly argued for the establishment of an Essential Diagnostics List (EDL) modeled on the existing Essential Medicines List (EML). T...


Physician Office Lab Market Gets a Shot in the Arm: Newly CLIA-Waived Alere i Molecular Flu Test

Physician Office Lab Market Gets a Shot in the Arm: Newly CLIA-Waived Alere i Molecular Flu Test

Rapid influenza (flu) testing is a high-profile fixture of the physician office laboratory (POL) diagnostics market. Easy-to-use lateral flow tests and other immunoassays run on automated readers are adequately reliable for primary care, urgent care and inpatient care settings. Such products also push infectious disease testing into the point-of-care (POC) and near-patient testing arena, allowing providers to initiate care during the same visit or day. Rapid flu tests represent significant reven...

  • by esalazar@marketresearch.com
  • November 5 2014
  • POL


How and Where IVD Will Find Growth in the Global POL Market - Part 2

How and Where IVD Will Find Growth in the Global POL Market - Part 2

( The first post of this series reviewed growth prospects for several POL test segments. Here the global POL market is discussed in terms of its regional segments )

Regulators and payers worldwide have been forced by the proliferation of point-of-care (POC) and near-patient test devices to address the allowable and suitable role of the physician office laboratory (POL). Payer acceptance of POL testing has varied. In some countries, the POL has been supported by higher schedule fees. In others,...

  • by esalazar@marketresearch.com
  • September 5 2014
  • POL


How and Where IVD Will Find Growth in the Global POL Market

How and Where IVD Will Find Growth in the Global POL Market

Unlike laboratory medicine (or lab pathology), there is no settled role for professional point-of-care (POC) or “near-patient” testing (NPT) in modern healthcare systems. The use of decentralized IVD testing in primary and outpatient care, most often in physician office laboratories (POLs), is not uniform worldwide nor is it universally supported. Nonetheless, payers, regulators and administrators are forced to address POL testing as the capabilities of benchtop and portable IVD instruments and ...


Pillars of U.S. Physician Office Testing - Clinical Chemistry

Pillars of U.S. Physician Office Testing - Clinical Chemistry

Urinalysis , hematology , clinical chemistry - core lab workstations are found not only in the centralized clinical lab, but also the physician office laboratory (POL). Seeking to transcend the low ceilings for growth in traditional clinical lab markets, IVD companies have developed numerous systems to perform core lab tests without the footprint or complexity of centralized lab platforms. The result has been benchtop and portable clinical chemistry analyzers equally applicable to the POLs of de...


Pillars of U.S. Physician Office Testing - Prothrombin Time (PT/INR)

Pillars of U.S. Physician Office Testing - Prothrombin Time (PT/INR)

Coagulation testing has a sprawling presence in IVD markets as it is able to be performed in virtually all segments, similar to blood glucose testing. The most common coagulation test is prothrombin time (PT) and its relative score indicated through the international normalized ratio (INR) (commonly referred to together as PT/INR), which can be performed in clinical labs, hospitals, physician offices, clinics, ambulatory care, and even homes. The ubiquity of the test is a result of its widesprea...


Pillars of U.S. Physician Office Testing - Complete Blood Count (CBC)

Pillars of U.S. Physician Office Testing - Complete Blood Count (CBC)

The ready-made popularity of CLIA-waived tests has not crowded out more complex tests from the physician office laboratory (POL) market. Some diagnostic tools are well-suited for placement across the spectrum: from the core lab workstations of central labs to the bench top of a physician practice. Performed on an impedance- or optical-based hematology analyzer, the complete blood count (CBC) is easily situated within a POL through compact, bare-bones models requiring no floor space and other inn...


Pillars of U.S. Physician Office Testing - Urinalysis

Pillars of U.S. Physician Office Testing - Urinalysis

A given in near every general practitioner’s office or primary clinic, dipstick urinalysis requires only a disposable collection cup, test strip, and sink. The test is routine, simple, multiplexed and extremely low-cost (strips cost $0.05 or less each) - tested parameters include urine bilirubin, glucose, hemoglobin, ketone, leukocytes, nitrites, pH, protein, specific gravity and urobilinogen. Similar to more complex chemistry panels, dipstick urinalysis can alert clinicians to multiple conditio...


On the Prospect of CLIA-Waived Differentials

On the Prospect of CLIA-Waived Differentials

Hematology testing such as complete blood counts (CBC) and differentials is customarily the domain of clinical laboratories. Instrument automation and the innovation of compact, streamlined models, however, has made such testing possible outside of the lab. Today’s hematology analyzers range from autoloaded, high-throughput and flow cytometry-capable in the lab to closed-menu, benchtop and ease-of-use at a clinic or physician’s office. While labs in the developing world continue to fuel market g...


Hematology Industry Mapping and Its Boundaries

Hematology Industry Mapping and Its Boundaries

Laboratory hematology is largely synonymous with its leading vendors such as Beckman Coulter and Sysmex. High order volumes among such vendors are ensured through established relationships with premium clients such as care networks, other large healthcare institutions, clinical laboratories, and reference labs. The profile of companies such as Beckman Coulter and Abbott Diagnostics is also higher due to the breadth of their product offering, particularly within the core lab - clinical chemistry,...