• by Emil Salazar
  • August 10 2016


U.S. Hospitals Leverage New IVD Products in the Fight Against Critical Inpatient Infections (AACC 2016)

U.S. Hospitals Leverage New IVD Products in the Fight Against Critical Inpatient Infections (AACC 2016)

This blog post continues Kalorama Information’s coverage of the 2016 AACC Annual Meeting in Philadelphia. Additional coverage of trends in the U.S. IVD market as well as segment market sizes and projections are available with Kalorama’s recent market research report.

With mounting cost pressures on U.S. labs and the growing accountability of diagnostics in critical patient episodes, vendors at the 2016 Annual Meeting of the American Association of Clinical Chemistry (AACC) emphasized solutions that addressed lab efficiency and mitigation of added healthcare costs. Test and workflow automation solutions at the AACC expo in Philadelphia were reviewed in a previous blog post as relevant tools for improving lab cost efficiency. Diagnostics are also crucial tools for hospitals to avoid payment penalties resulting from poor performance or non-compliance with care standards related to hospital-acquired infections (HAIs) and sepsis. Sepsis alone cost U.S. hospitals $20.3 billion in 2011, underscoring its significance within hospital budgets. In response, diagnostic vendors at the AACC meeting emphasized quality control (QC) products and test products used to implement more effective testing regimens around critical inpatient infections.

With a broad portfolio of tests for critical inpatient infections, bioMérieux’s perspective on sepsis is worth noting. In Philadelphia, the company highlighted its VIDAS B•R•A•H•M•S procalcitonin (PCT) assay with a newly expanded claim for monitoring sepsis patient PCT levels over 96-hour intervals. Procalcitonin assays offered by bioMérieux, Roche and Thermo Fisher Scientific are uniquely able to address sepsis testing from the early stage of bacteremia or infectious systematic inflammatory response syndrome (SIRS) through severe sepsis and septic shock. Elevated PCT can help to differentiate infection-related SIRS and sepsis from non-infectious inflammation. The biomarker can also be used to monitor treatment during severe sepsis and septic shock (greater than 80% decrease in PCT levels in is associated with significantly lower risk of 28-day mortality). During AACC 2016, Thermo Fisher held its own workshop to explore how PCT assays can be integrated into sepsis core measure bundle care. The market for immunoassays used in sepsis and HAI testing is expected to grow by roughly 4% annually in the United States through 2020.

Treatment guidelines or bundles for sepsis are part of CMS’s Hospital Inpatient Quality Reporting program that assigns payment reduction penalties for non-compliance. The inclusion of sepsis as a core measure of CMS’s value-based purchasing (VBP) program will also reward hospitals with incentive payments for properly reported (diagnosed) sepsis cases that received high-quality care. Sepsis could also factor into VBP by improving the cost efficiency of care and patient 30-day outcomes, further incentivizing hospital usage of PCT assays.

Improved patient outcomes for sepsis can also depend on shorter timelines for the identification of causative infection. bioMérieux has addressed the entire workflow for bloodstream infection identification with new products including its next-generation automated blood culture system, BacT/ALERT VIRTUO, recently submitted for FDA clearance; its FDA-approved qPCR FilmArray panel for the identification of pathogens from positive blood cultures (BCID panel); and VITEK MS platform for the mass spectrometry-guided identification of pathogens from blood culture colonies. These products can be used to identify pathogens within the first 48 hours after hospital admission. More timely identification of infections can allow earlier implementation of targeted antibiotic therapies if there is insufficient response to initial broad-spectrum antibiotics. Advanced bloodstream infection identification assays such as in molecular biology are expected to find U.S. market growth surpassing 8% through 2020.

In the past eight years, hospitals in the United States have aggressively addressed a group of critical inpatient infections known as nosocomial or hospital-acquired infections. Such infections are associated with opportunistic pathogens and antibiotic-resistant bacterial strains. Hospitals and other U.S. healthcare providers have invested heavily on HAI control tools such as disinfection, safer devices, and diagnostics. Medicaid ceased providing payments to states for services related to HAIs and other hospital-acquired conditions in 2011. Medicare had made a similar decision in 2008 in order to encourage hospital investment in HAI control.

The Hospital-Acquired Condition Reduction Program (HACRP) established by the ACA began applying penalties in the 2015 fiscal year for hospitals ranking in the worst-performing quartile (25th percentile and higher in HAC score) for hospital-acquired conditions including HAIs. The payment penalty for low performance according to risk-adjusted HAC quality measures is a 1% reduction of payments paid by Medicare upon discharge.

The fiscal importance of controlling and eliminating HAIs motivated a surge in hospital lab investment in rapid, sensitive and specific molecular analyzers used to test for MRSA, C. difficile and vancomycin-resistant bacteria (VRE) among other threats. Even as platforms such as the Cepheid GeneXpert have become prevalent among U.S. hospitals, external QC products for associated tests have been lacking until recently. At an AACC 2016 press conference, Bio-Rad Laboratories introduced new QC products for molecular testing, including its de novo FDA-cleared multiplex molecular Amplichek II QC kit for MRSA, C. diff, VRE/vanR, and MSSA. The multiplex molecular HAI QC product contains inactivated bacteria rather than naked nucleic acids and can be used to more reliably determine analyzer performance near its limit of detection (LOD). Molecular QC products are an expected area of growth as molecular testing has become mainstream as QC product availability has lagged behind. Molecular HAI testing, in particular, has a strong need for third-party QC products to mitigate hospitals’ avoidable costs arising from inaccurate testing and HACRP penalties.

While disruptive and new diagnostic technologies were far from absent at AACC 2016, regulatory and operational flux from, among other things, rising post-Affordable Care Act (ACA) healthcare utilization, implementation of market-based pricing under the Protecting Access to Medicare Act (PAMA), other elements of healthcare reform, value-based health care and healthcare consolidation have driven lab investment towards core operations and products that cut away avoidable costs. This has been an apparent trend in the U.S. IVD market since 2014 when investment in new core lab platforms and additional capacity rose in response to ACA implementation. At a time of exciting advances in biotechnology and translational medicine, the 2016 AACC Annual Meeting demonstrated strong outstanding demand among labs for the optimization and assurance of current testing practices.