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 developed markets and resource-strained clinical labs of the developing world. The results from several routine chemistry panels and many conventional chemistry parameters are now available to patients during the same consultation or visit, informing physicians to investigate more specific diagnoses.

An extensive review of secondary sources and regulatory filings suggests that clinical chemistry panels and parameters represent the fourth-most commonly performed test in U.S. POLs behind dipstick urinalysis, the complete blood count (CBC), and prothrombin time (PT). Similar to the CBC and dipstick urinalysis, clinical chemistry parameters assess organ health and non-specifically screen for health conditions.  Common parameters on low-volume chemistry analyzers used in POLs include ALT, AST, GGT, ALP, AMY, blood urea nitrogen (BUN), creatinine, electrolytes, glucose, bilirubin, and uric acid. Electrolytes can also be tested on many POL chemistry analyzers.

Leading companies and systems in the POL chemistry space include Abaxis’ Piccolo Xpress (waived); Abbott Diagnostics’ i-STAT (waived; in the United States used primarily outside of the POL market in critical care); Alfa Wassermann’s ACE Alera and Axcel; Arkray’s SPOTCHEM EZ (waived); Carolina Liquid Chemistries’ integrated chemistry system BioLis 24i; HORIBA Medical’s Pentra 400 and Pentra C200; Mindray’s BS-200; Ortho-Clinical Diagnostics’ VITROS DT60 II; and Roche Diagnostics’ cobas c 311, c 111 and 4000 series. Specialists in low-volume and POL chemistry analyzers include Abaxis, Alfa Wasserman, and HORIBA Medical.

The U.S. market for POL chemistry analyzers is mature with minimal market growth in recent years. Most sales success for low-volume and handheld analyzers has been realized in critical care markets and overseas within expanding healthcare systems featuring high demand for improved small lab functionality. Prohibitive factors to the expansion of the U.S. POL clinical chemistry market include the lack of growth in the number of CLIA compliance (moderate and high complexity) POLs, centralization of core lab testing and declining reimbursement for heavily automated tests. Many POLs only perform in-office clinical chemistry testing when a value proposition is presented through high patient (and test) volume. Specialty clinics and group practices consequently are ideal POL chemistry adopters with potential high in-house test volume through patients requiring disease monitoring. Fewer and fewer small practices are likely to adopt in-office chemistry testing in the face of declining reimbursement. Also weakening office- or practice-performed chemistry, practice consolidation in the United States places more offices and potential POL sites within networks or organizations served by hospital labs or other centralized clinical labs.

For more information regarding physician office laboratory (POL) markets, please consult Kalorama Information’s recently published Physician Office Laboratory Markets.