The document summarizes key events and announcements from the American Association of Clinical Chemistry conference in 2016. It discusses the controversial presentation by Theranos on a new product and questions from the audience. It also describes new automated solutions and products showcased by various companies to improve laboratory efficiency. Retail clinics were a strategic focus for companies wanting to adapt to decentralized testing.

1. What You May Have
Missed at AACC 2016
As the laboratory and IVD industry met in
Philadelphia for the American Association of
Clinical Chemistry, there was publicity and
talk of industry disruption. There was also a
focus on automated solutions, dealing with
Zika and new scientific discoveries.
The pace of vendor exhibitions at the American
Association of Clinical Chemistry in Philadelphia, PA,
held July 31st
to August 4th
, 2016, was frenetic as the
early session featuring controversial test maker
Theranos, as many leaders put their automation solutions front and center. While the first session
attracted rare national news attention to this meeting and clinical testing generally, the story at the booths
was enhanced products, particularly those to assist in productivity. If you did not get a chance to come to
Philadelphia this year, or if you were there but looking for a broad perspective on the meeting, this brief
White Paper sums up our analysts’ findings and provides links for more information.
Theranos Provides Excitement, Controversy
It was an odd beginning for a clinical chemistry convention with rock music,
security‐enforced crowd control and the presence of national media as
controversial Silicon Valley test maker Theranos presented on Monday.
Kalorama Information attended the event. Prior to the meeting AACC President
Patricia Jones made clear that AACC was not endorsing Theranos. CEO Elizabeth
Holmes surprised some of the packed crowd of lab managers, pathologists and
industry representatives by introducing and providing prelim validation data for
a new product, MiniLab, a cartridge‐based testing system. The MiniLab is not
FDA‐approved and data presented to the conference was not peer‐reviewed or
approved by regulators. Questions from AACC members followed, moderated
by Dennis Lo, PhD, Steven Master, MD, PhD, and AACC President Jones as well
as other non‐affiliated scientists. This audience of lab professionals was focused on data, and many
remained skeptical of the company’s claims. At one point when Master informed Holmes that the data
presented fell “far short” of what was expected based on the wide menu promised previously, the audience
Keep Up With the IVD Market: Follow KALORAMA INFORMATION on Twitter: @KaloramaInfo

2.
clapped. Holmes said the company took complete responsibility for its lab operations and said the
company brought in new lab directors and rebuilt quality systems. She said the AACC appearance was not
a claim at “assay validation.” For more information on the talk, see Clinical Laboratory News
https://www.aacc.org/publications/cln/cln‐daily/2016/wednesday/theranos‐opens‐up‐the‐box
Faster and Easier Systems Prominent in Vendor Booths
While the technological trajectory of the IVD market arcs further upward with next‐generation sequencing
(NGS) and mass spectrometry, more immediate investment priorities for labs figure to include core lab and
workstation automation, judging by floor space. Siemens
Healthineers used the AACC Annual Meeting to unveil its
Atellica Solution for automated core lab testing. The highly
flexible immunoassay‐clinical chemistry system includes a bi‐
directional magnetic sample conveyance system for improved
speeds over conventional conveyors. Other conspicuous lab
automation solutions at AACC booths:
• Thermo Fisher Scientific’s line of Phadia
immunoanalyzers for automated autoimmune and allergy testing was showcased with floor models
of the scalable Phadia 250 and high‐throughput 2500. The Phadia 100 was not displayed due to
rising importance of centralized, fully automated autoimmune testing.
• Abbott Diagnostics unveiled its Alinity line of “harmonized systems” across the core lab (clinical
chemistry and immunoassays), hematology, point‐of‐care (POC) diagnostics, blood screening, and
molecular diagnostics. The Alinity line of instruments will be supported by Abbott’s suite of AlinIQ
professional services for labs as well as common informatics software across instruments for
efficient, unified testing workflows.
• Becton, Dickinson & Co. (BD) showcased its compact Kiestra Work Cell Automation (WCA) suitable
for space‐constrained hospital microbiology labs and other
configurations for automated specimen processing, plate i
and plate imaging.
ncubation,
Keep Up With IVD Developments: Follow KALORAMA INFORMATION on Twitter at @KaloramaInfo
IVD Companies Aim at Retail Clinics
Getting to small venues, including retail, urgent and work clinics, while still
maintaining presence in large labs was a strategic desire expressed by many
IVD companies, most notably by Roche Diagnostics. Roche is the No 1. IVD
company with $12 billion plus in revenues, according to Kalorama
Information’s The Worldwide Market for In Vitro Diagnostic Tests, thus its
concerns provide a useful bellwether of the IVD industry. At Philadelphia,
the company detailed how it intended to stay in its position by accounting
for market changes. A key strategy is confronting both decentralization
Roche Presented the cobas Liat, a PCR
point of care platform, which recently
received CLIA –waived status for Flu A/B
and RSV.
With much fanfare, Siemens Healthineers debuted
the Atellica Solution.

3. and
centralization at the same time. They’ll do this, executives said, with systems for smaller venues and
solutions for larger labs that would be vitrually tied in. “There is increasing demand among integrated
health networks for greater centralization of diagnostic testing to streamline workflows and put
comprehensive patient information at the healthcare professional’s fingertips, quickly,” said Jack Phillips,
president and CEO of Roche Diagnostics Corporation. In several slides, Phillips highlighted the
consolidation of hospitals, the decentralization of testing venues, and notably the proliferation of retail
clinics. There are over 2,000 retail clinics, according to Kalorama’s estimates. Retail Clinics made of $1
billion dollars in sales, according to Kalorama’s report on retail clinics, available at
www.kaloramainformation.com (updated report in August).
Roche Diagnostics announced its minature PCR system – the cobas Liat – at the meeting, CLIA‐waived for
flu a/b, RSV and strep. The new product is part of the company's plans to continue to lead in the market. A
key strategy is trading on the heritage and legacy of their large systems to ensure that they pick up all of
the POC and other tests that are being conducted in a “virtual connection.”
IVD Product Developments on Display at AACC 2016
• Bio‐Rad announced a new quality control product that can be
used on multiple platforms. Amplichek II is a quality control
for use with nucleic acid assays detecting common pathogens
causing healthcare‐associated infections (HAI). The product is
liquid, compatible with sampling tools such as swabs and
pipettes. It has a 2 year shelf life at 2–8°C according to the
company. The single use product includes multi‐analyte for
HAI (C diff, VRE, MRSA). This product is important for hospital labs performing the in‐house
molecular testing as part of their HAI control programs. The product uses inactivated bacteria
instead of naked nucleic acids used in internal controls – so a better indicator of test performance.
• Instrumentation Laboratories introduced its new ACL TOP Family 50 Series Testing Systems, with
advanced automation for routine and specialty testing. Each model integrates pre‐analytical
sample integrity checks, advanced quality management and lab accreditation tools.
• Abbott Diagnostics unveiled AlinIQ, a professional services and informatics
solution that enables labs to deliver greater productivity with their existing
resources Abbott also announced the new CELL‐DYN Emerald 22 automated
hematology analyzer. CELL‐DYN Emerald 22, a compact 5‐part differential
hematology analyzer, offers big lab results with small lab requirements. The small
footprint, low reagent consumption, and easy to use features make the ideal
choice where space and specialized staff are limited.
Keep Up With IVD Developments: Follow KALORAMA INFORMATION on Twitter at @KaloramaInfo

4.
Keep Up With IVD Developments: Follow KALORAMA INFORMATION on Twitter at @KaloramaInfo
• Sebia introduced the CAPILLARYS 3 TERA instrument for high resolution capillary separation of
proteins, hemoglobins, and HbA1c. The CAPILLARYS 3 TERA offers enhanced throughput with 12
capillaries, increased walk‐away capabilities and more flexibility for high volume laboratories.
• Luminex presented its ARIES M1 System. The company announced recently it has received FDA
clearance and CE‐IVD marking. The ARIES M1 System is designed to allow satellite clinical
laboratories to take advantage of the higher throughput ARIES System, with features such as an
intuitive system interface, STAT or batch testing, and what the company says is “walk‐away
capability.” Once the cassettes are loaded onto the instrument, results are generated without
additional technical intervention.
• Alere announced that the epoc Blood Analysis System delivers blood gas and electrolyte results in
about 30 seconds, and is the only wireless bedside testing solution to use “SmartCard” technology.
The epoc® BGEM Test Card has 11 analytes including Creatinine with eGFR and Chloride.
• Roche unveiled a cobas c 513 analyzer — a dedicated high‐volume HbA1c testing solution designed
to fulfill the needs of high‐volume laboratories, while also meeting the new requirements for
HbA1c testing. (Product has 510(k) submission pending clearance. Not available in U.S.) Roche also
presented its cobas 6800 – a high‐volume liquid sample molecular analyzer that the company said
the system can handle high‐volume molecular tests. Lab Developed Tests can be loaded in
refrigeration in instrument and informatically run. The system also can handle pooled samples for
NAT blood screening and is the platform for Roche's Zika assay.
• bioMérieux used the meeting to highlight that the U.S. Food and Drug Administration (FDA)
recently decided to expand the use of the VIDAS® B R A H M S PCT (Procalcitonin) assay using the
change in PCT levels over time to aid in the management of sepsis patients after the initial
diagnosis. Based on a recent study, monitoring PCT levels over 4 days (96 hours) can help doctors
determine which septic patients are at the greatest risk of death, enabling them to adjust or
intensify the medical care for those patients. “The study demonstrates that for patients diagnosed
with sepsis or septic shock, failure of blood concentrations of PCT to decrease over 96 hours is a
strong predictor of mortality over and above clinical indicators,” said Mark Miller, Chief Medical
Officer at bioMérieux.
• Thermo Fisher Scientific Inc. announced at AACC that it received 510(K) clearance from the U.S.
Food and Drug Administration (FDA) for two new EliA IgG tests for detecting anti‐Thyroglobulin
(anti‐TG) and anti‐Thyroid Peroxidase (anti‐TPO) autoantibodies in serum or plasma. The CLIA‐
moderate laboratory tests are performed on the fully‐automated Phadia 250/2500/5000
Laboratory Systems.
For more information on new products, see AACC’s new product showcase at
http://events.jspargo.com/AACC16/Public/Enter.aspx

5.
Keep Up With IVD Developments: Follow KALORAMA INFORMATION on Twitter at @KaloramaInfo
New Testing‐Based Science Unveiled at Scientific Sessions
• Latest Research on Cannabis Use: As legal recreational and medical marijuana use gains traction, it
is critical that law enforcement has a way to test for whether someone is driving under the
influence. However, recent research has revealed that determining wheter a driver is impaired by
marijuana is much more complicated than testing for blood alchohol.
• cfDNA (cell free DNA) Applications have advanced. Michael Oellerich, MD, spoke on its use in
organ transplant monitoring in female recipients and male donors. The presence of organ donor
graft‐derived cfDNA in a receiver’s serum is a red flag of rejection, according to the symposium.
Detecting rejection of the transplanted organ early is important for the 300,000+ living graft
recipients in the U.S. and could help minimize wasted donations in a time of donor shortage. Rossa
Chiu, PhD, spoke to how cfDNA can be used as a “total body scan” to find cancer earlier. This –
along with the more common use of cfDNA in prenatal testing – was examined at the symposium.
• Bio‐Nano‐Chip: John T McDevitt, PhD, of the College of Dentistry of New York University, delved
into the programmable bio‐nano‐chip, a mobile health testing platform that could make it possible
to diagnose conditions such as cancer, cardiovascular disease and infectous diseases with a device
the size of a credit card chip.
• First NGS HIV Drug Resistance Test: Research announced at the AACC demonstrated that a next
generation sequencing test could detect HIV drug resistance mutations that conventional tests fail
to identify. The test could play a critical role in helping clinicians to optimize HIV treatment
regimens, while also helping public health initiatives to minimize the development of global
resistance to antiretroviral drugs.
• CRISPR – short for “Clustered Regularly Interspaced Short Palindromic Repeats” – has made
genome editing easy by enabling researchers to quickly and precisely cut and paste segments of
DNA. This technique shows incredible promise and could potentially be used to treat conditions
ranging from inherited vision loss to HIV. Experts at AACC examined how CRISPR could be used to
edit the body’s T cells and instruct them to detect and destroy cancer cells.
More information on scientific sessions held at AACC is available from the organization at www.aacc.org

6.
Zika Challenge Spurs New Tests
AACC featured many companies vying to produce tests for the Zika virus The publicity regarding the
disease and the few incidents in the United States spurred interest at the AACC meeting in Philadelphia.
Kalorama queried vendors at AACC about current Zika projects. The efforts underway include the following:
• In June, Hologic and Grifols announced that the FDA approved use of the Procleix Zika virus
blood screening assay on the Procleix Panther system under the agency's Investigational New Drug
(IND) study protocol. The assay is a molecular diagnostic tool for the qualitative detection of RNA
from Zika virus in serum and plasma specimens. This allows U.S. blood centers to use the Procleix
Zika virus assay to screen donated blood collected in potential endemic areas of the southern U.S.,
and may expand testing to other areas of the U.S. if the virus continues to spread.
• In April, Quest Diagnostics received a U.S. Food and Drug Administration (FDA) Emergency Use
Authorization (EUA) for the Zika Virus RNA Qualitative Real‐Time RT‐PCR test (Zika RT‐PCR test).
The proprietary molecular test is intended for the qualitative detection of RNA from the Zika virus
in human serum specimens from certain individuals. Quest Diagnostics planned to make the new
test broadly available to physicians for patient testing, including in Puerto Rico, in May 2016. This
test can potentially be performed at any CLIA high‐complexity laboratory in the Quest Diagnostics
network, which includes several dozen labs in the United States, including in Toa Baja, Puerto Rico.
• In March, Roche announced that the U.S. FDA provided approval to initiate collection and
testing of blood samples for screening with the cobas Zika assay under an Investigational New Drug
Application (IND) protocol. The cobas Zika test for use with the cobas® 6800/8800 Systems is a
qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma
specimens from individual human blood donors.
• In February, Thermo Fisher Scientific announced the U.S. availability of the EUROIMMUN
(Luebeck, Germany) Anti‐Zika Virus ELISA and indirect immunofluorescence (IFA) test formats in the
U.S. to enable serological detection of the Zika virus in research applications. The kits can
differentiate between Zika, dengue and chikungunya viruses. These tests also enable researchers
to detect the virus in samples over a much longer period of time than is possible with current
direct‐detection assays. The tests allow researchers to detect specific antibodies (IgM and IgG) in
blood samples.
Keep Up With IVD Developments: Follow KALORAMA INFORMATION on Twitter at @KaloramaInfo
Want More Information on the IVD Industry?
Visit www.kaloramainformation.com for detailed information about our market
research reports that can save you time and provide objective benchmarking of
your company’s position in the market and efforts, as well as revealing trends.

7.
For 10 Editions, the Most Definitive
Research Study of the IVD Market
The Worldwide Market for In Vitro Diagnostic Tests 10TH EDITION.
The biennial edition of Kalorama’s study of the IVD market is coming soon.
It’s a simple concept, but one that has assisted hundreds of IVD market professionals,
investors and other researchers. One volume that tracks all of the important trends, all of
the new product launches, announced partnerships and acquisitions in the diagnostic
testing industry. In ten best-selling editions, Shara Rosen has cut through unimportant
details and company hype and detailed the market for in vitro diagnostic (IVD) testing,
throughout the world, in one complete volume. Market numbers and market share,
matched with a discovery of unique trends in every major IVD market segment:
Clinical Chemistry and "Core Lab" Markets (including subsegment revenues for General Chemistries, Workstations,
Analyzers Blood Gases, Urinalysis, Critical Care)
Point of Care Testing (POC) (Professional and Self-Testing, Glucose Testing, Pregnancy Tests, drugs of abuse, HIV, H.
pylori, Other, OTC/Self Total, Professional POC, Cardiac Markers, Drugs of Abuse, HbA1c, Pregnancy, Other)
Histology, Tissue-Based Tests, Cytology (Pap, ISH, IHC, HPV)
Microbiology Immunoassay Testing  (Hepatitis, HIV, STDs, TORCH, Respiratory, Sepsis, Parasitology, Mycology,
Others)
Molecular Assays (Inf. Dis., Blood Screening, Inherited Diseases, Oncology, Pharmacodx, Tissue Typing, Prenatal)
Hematology
Molecular Tests in Infectious Diseases (HAI, HIV, Hep., GC/Chlamydia, RSV, Organism ID, Mycobacteria, TB, Others)
Immunoassay Sales by Analyte Type (Cardiac Markers, Tumor markers, Diabetes/HbA1c, Autoimmune, Allergy, Thyroid,
Proteins, Anemia, Fertility, Therapeutic drugs, Tox/Drugs of abuse, Vitamin D)
Coagulation Tests (Lab-Based, POC, Genetic Markers)
Microbiology and Virology by Test Type (Immunoassays, ID/AST, Infectious Diseases - DNA; ID/AST: Panels and
Reagents, automated; Panels and Reagents, manual; Blood Culture; Chromogenic Media; Rapid Micro; Supplies)
Blood Banking (Grouping, Immunoassay Screens, NAT Screens)
The report, The Worldwide Market for In Vitro Diagnostic Tests, combines real industry knowledge with an exhaustive
review of the medical, business, and company literature. As part of its coverage, the report breaks down the entire IVD
market for North America, Europe (EU countries, incl. IVD market sizes by country), Eastern Europe, South America, Asia
(Japan, China and India) and Rest of World.
TO BE PUBLISHED AUGUST 22ND
, 2016
http://www.kaloramainformation.com/Worldwide-Vitro-Diagnostic-10206771/