Market Overview

Early Adopters Say Atellica Solution Exceeds Their Performance Expectations and Delivers Unprecedented Efficiencies

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  • As the shortage of skilled clinical laboratory workers continues to
    rise, the Atellica Solution by Siemens Healthineers is proving to be a
    valuable asset for laboratories.
  • World-renowned laboratories' workflow and performance studies
    succeeded in KPIs such as turnaround time, throughput, hands-on system
    time, and assay performance.
  • Consolidation of STAT and routine testing, and reduction in
    operator hands-on time are two workflow transformations benefitting
    lab operations, physicians, and patients.

70th AACC Annual Scientific Meeting & Clinical Lab Expo, Booth #2812

Clinical laboratories are challenged to meet greater testing demands,
improve efficiency, and deliver reliable, high-quality results, while
facing an increasing shortage of skilled employees1 and
growing budget constraints. Recognizing that technology can play a
critical role in addressing each of these challenges, Siemens
Healthineers brought to market the Atellica® Solution2
immunoassay and clinical chemistry analyzers for in vitro diagnostic
testing. Six early adopters of the Atellica Solution recently reported
their respective workflow and performance studies, each of which
validate the solution's ambitious commitments to transform operational
efficiency and enhance clinical performance.3 Their results,
in each instance, exceeded key performance indicators that affect
workflow—including turnaround time, throughput, operator hands-on time
with system maintenance and quality control, as well as assay
performance.

Significantly Reduced Time for System Maintenance and Quality Control
Protocols

The Atellica Solution addresses staffing challenges with innovative
features such as automated quality control and calibration, a
sophisticated vision system, and intelligent sample management and test
scheduling. Tied together by a unique bidirectional magnetic sample
transport technology, the features work together and condense the
workload for highly skilled operators to help refocus their attention
elsewhere in the lab. Less hands-on time for routine tasks maximizes
existing resources and reduces the need for additional operators as
laboratory operations grow.

Utilizing the onboard maintenance and quality control capabilities,
Hospital Clinic Barcelona and LBM Bioesterel of France delivered their
typical high-volume throughputs with 60 percent and 73 percent less
hands-on time respectively, and staff productivity improvements of 13
percent and 21 percent respectively. Access Medical Labs in Florida, USA
experienced similar results, reducing hands-on time from an average of
one hour to less than 10 minutes per day.

"The time a technologist needs to keep a system working is very
important, and it consumes many hours per day. Tasks such as
maintenance, QC and calibration, and reagent loading require a lot of
time," said Dr. José Luis Bedini, Head of the Core Lab Operative Area at
Hospital Clínic de Barcelona. "We are always facing challenges to design
and develop new tests that we can offer to our patients and to our
clinicians. The only way to do this is to relocate resources from the
routine lab to the specialist lab, which we are expecting to achieve
with the Atellica Solution."

Shorter Turnaround Times for Improved Patient Care

In a study with more than 300 physicians and lab directors, more than 60
percent of respondents reported that fast turnaround time for IVD
testing results has high value to physicians4, as the results
aid in more than 70 percent of clinical decisions—decisions that can
better guide treatments and interventions, reduce the length of hospital
stays, and improve patient care.

Institutional protocols contribute to turnaround time, but ultimately
the speed at which labs deliver results is determined by the time it
takes to process a test. There are times when some assays need to have
longer incubation times for optimized performance. Prior to the Atellica
Solution, the type of test and mix of tests could impact an analyzer's
entire throughput and capacity to produce results in a given time.

To address this challenge, some laboratories designate analyzers and
staff to accommodate those assays that require extended analytical
times, or STAT assays that need to be processed as quickly as possible.
The Atellica Solution eliminates the need for dedicated specialty
analyzers making the entire process—including workflow—more efficient.

"With the management of STAT and routine tubes on the Atellica Solution
… the turnaround times for an emergency greatly exceed our expectations.
The management of routine samples is not impacted, with a turnaround
time that is very much lower than what we provide currently," reported
Dr. Malik Jlaiel, Associate Director of LBM Bioesterel in France.

Independent sample management capabilities, bi-directional Atellica
Magline® Transport technology, and dual-ring incubation are helping
laboratories to achieve turnaround times from 22 to 53 percent quicker.5

"Atellica Solution is able to provide significantly shorter turnaround
times, and this facilitates the treatment and appropriate care of
patients, compared with the previous situation," said Dr. Antonio Buño
Soto, Head of Laboratory Medicine Department at Hospital Universitario
La Paz, one of the largest in Madrid.

Modernizing Workflow with Sample Integration to Transform Care
Delivery

About half of physicians and internists surveyed agreed that investments
in lab technology would be very impactful on improving patient outcomes.4
The ability to load STAT samples on the Atellica Solution
alongside routine samples—without affecting turnaround time of either
test—is a paradigm shift for laboratories that currently operate with
dedicated analyzers or dedicated STAT labs adjacent to the emergency
rooms.

Such is the case at Hospital La Paz Laboratory. "With the Atellica
Solution we have a solution that permits the true prioritization of
urgent samples, even when one is processing and analyzing routine
samples, and this will facilitate new forms of organization in labs. We
could do away with the need to have independent equipment for STAT
tests," Dr. Buño Soto added. Eliminating STAT labs means freeing
valuable staff time and floor space for other specialized testing or
greater testing capacity.

Similar results were achieved at Hospital Clinic de Barcelona. "Now we
have dedicated analyzers for STATs, but in the future we will just have
the Atellica Solution," said Dr. Bedini. "The whole organization of the
lab will change as we'll be using the same systems for both routine and
STAT at the same time. The clinicians need results as soon as possible
to care for patients, especially those that have very critical
conditions."

The number of analyzers required to achieve the same throughput and
turnaround time as current systems was reduced by 33 percent with the
Atellica Solution.5 This reduction means acquisition and
operational costs of additional analyzers are eliminated and fewer
technicians are needed to maintain the instruments.

Strong Assay Performance to Improve Precision Medicine

As laboratories continue to consolidate and utilize both new and
existing instruments across their healthcare systems, laboratories must
take care that patient results are precise, accurate, and concordant
anywhere within the system. These three elements help avoid the need to
retest samples.

The six customers' Atellica Solution studies were conducted using
Clinical and Laboratory Standards Institute guidelines to assess the
concordance, precision, linearity, and detection capability compared to
those reported in the assay's Instructions for Use. Among the assays
assessed for performance at LBM Bioesterel was the Atellica® IM
TSH3-Ultra™ Assay for thyroid function, versus the ADVIA Centaur TSH3-UL
and Roche ELECSYS TSH assays. The TSH3 assay was selected because it is
one of the most common test requests. Biotin interference also was
studied.

The Atellica® IM TSH3-Ultra Assay demonstrated a coefficient of
variation at or below 6 percent—below those reported in the Instructions
for Use—at three control levels. The analytical time-to-result, when
compared to the predicate system, decreased by 22 percent. The assay had
greater than 99 percent correlation to corresponding ADVIA Centaur® and
Roche ELECSYS TSH assays. Further, there was no interference of biotin
at up to 500 ng/mL—whereas the competitor assay was significantly
impacted by biotin at 500 ng/mL.

"Assuring that our methods have no interferences is absolutely helpful
for patient care because we can avoid drawing a second sample, which
impacts the time it takes to have a definite or conclusive result in
order to assure the correct patient care," said Dr. Buño Soto.

As labs focus on reducing cost burdens while meeting increasing testing
demands, they need solutions that are flexible to adapt as their needs
change. The Atellica Solution can address both current challenges and
evolve as the laboratory grows. No matter which key performance
indicators were of importance, the Atellica Solution delivered.

"I think the results are really excellent from both sides—from the
technical evaluations and from the workflow organizational studies. But
the most important thing to me has been to see how much my technologists
have reacted to the Atellica Solution," added Dr. Bedini. "Seeing people
experience the system for the first time and how they react—this for me
also is an excellent result because that means we are going the right
direction and that everybody is happy with the new system in the lab."

The results highlighted in this announcement will be presented during
poster presentations at the 70th AACC Annual Scientific Meeting &
Clinical Lab Expo in Chicago, Ill. from July 31 to August 2.

1 American Society for Clinical Pathology's 2016-2017 Vacancy
Survey of Medical Laboratories
2 Product availability
varies by country.
3 The outcomes obtained by the
Siemens Healthineers customers described here were realized in the
customers' unique settings. Since there is no typical laboratory, and
many variables exist, there can be no guarantee that others will achieve
the same results.
4 The Diagnostic Lab: The Hidden Jewel
in the Health System https://www.healthcare.siemens.com/magazine/mso-whitepaper-diagnostic-lab.html
5
Compared to Siemens Healthineers legacy systems.

Siemens Healthineers supported these studies by providing systems,
reagents, and protocols and contributed to data analysis.

Siemens Healthineers enables healthcare providers worldwide to
increase value by empowering them on their journey towards expanding
precision medicine, transforming care delivery, improving patient
experience and digitalizing healthcare. A leader in medical technology,
Siemens Healthineers is constantly innovating its portfolio of products
and services in its core areas of diagnostic and therapeutic imaging and
in laboratory diagnostics and molecular medicine. Siemens Healthineers
is also actively developing its digital health services and enterprise
services. In fiscal 2017, which ended on September 30, 2017, Siemens
Healthineers generated revenue of €13.8 billion and profit of €2.5
billion and has about 48,000 employees worldwide. Further information is
available at www.siemens-healthineers.com.

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