Quest Diagnostics 2007 Annual Report Download - page 16

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integrated solutions to physicians, hospitals and clinics for the testing methods that are most appropriate for each
patient and practice.
We develop and manufacture products that enable healthcare professionals to make healthcare diagnoses,
including products for point-of-care, or near patient, testing for the professional market. Since July 2006, we have
acquired several companies, including Focus Diagnostics, Enterix, and HemoCue, that enhance our offerings and
better enable us to serve these markets. We will consider additional acquisitions or licenses of selective products
to complement the products and services we provide. We offer an electronic data link through our Care360
Physician Portal so that the results of the InSureTM Quik FIT point-of-care tests, as well as tests performed by
our laboratories, will be available in one electronic medical record. We intend to offer additional data links in the
future. This will differentiate our point-of-care test products from other products that are not integrated into an
electronic repository.
Focus Diagnostics is a leading provider of infectious disease testing that has established a reputation for
being first to introduce new tests to the market, including diagnostic tests for Lyme disease, West Nile Virus and
SARS. Focus Diagnostics develops, manufactures and markets diagnostic products, such as HerpeSelectELISA
tests that detect patient antibodies to specific types of Herpes Simplex Virus, which can be performed on a
variety of instrument platforms. Focus received Food and Drug Administration (“FDA”) 510(k) clearance to sell
in the U.S. its new multiplexed Plexusproduct to detect type specific antibodies to herpes simplex virus. Focus
has also submitted an application to the FDA for 510(k) clearance to allow U.S. sales of Plexusproducts for the
detection of antibodies specific to Epstein-Barr virus. Both the Plexusproducts have received the CE mark and
are available for purchase in European Union countries. Focus Diagnostics sells its diagnostic products to large
academic medical centers, hospitals and commercial laboratories globally.
Enterix, an Australia-based company, manufactures the InSureTM fecal immunochemical (FIT) test for
screening for colorectal cancer. It has developed and plans to release early in 2008 the InSureTM Quik FIT test
for point-of-care testing.
HemoCue, headquartered in Angelholm, Sweden, specializes in point-of-care testing. HemoCue is the leading
global provider in point-of-care testing for hemoglobin, with a growing market share for professional glucose and
microalbumin testing. The measurement of hemoglobin is important for blood donors and for patients being
considered for transfusion therapy, or undergoing dialysis or chemotherapy, where instant test results can lead to
immediate treatment decisions. HemoCue’s handheld systems are used in physician’s offices, blood banks,
hospitals, diabetes clinics and public health clinics. In developing countries these systems are used as the primary
means to screen for anemia. Approximately one-half of HemoCue’s products are sold outside the United States.
HemoCue has a strong product development pipeline, based on its pioneering use of its patented microfluidic
systems.
In October 2007, HemoCue received FDA 510(k) clearance for its White Blood Cell Analyzer, a whole-
blood test performed on finger-stick samples that assist physicians diagnosing infection, inflammation, bone
marrow failure, autoimmune diseases and many other medical conditions now routinely tested by reference
laboratories. In addition, Focus Diagnostics received FDA 510(k) clearance for its HerpeSelectExpressTM
HSV-2, a test for aiding in the diagnosis of herpes simplex type-2 virus, the primary cause of genital herpes.
With 510(k) clearance for marketing, physicians who operate CLIA-certified moderately complex laboratories
may now use these products to quickly produce results in a single office visit. These two tests will help
physicians quickly determine the presence of an infection and allow physicians to make immediate treatment
decisions for their patients. We have applied for CLIA-waived status for these two products and a microalbumin
test which, if granted, would permit physicians to use these products in a much larger segment of physician
offices.
International. We have laboratory facilities in Mexico City, Mexico; San Juan, Puerto Rico; and Heston,
England. These laboratories support our clinical trials business and clinical testing in their local markets. In
addition, we have established operations in Gurgaon, India, that will support our business activities in that
country. We see opportunities to bring our experience and expertise in diagnostic testing and point-of-care
products to international markets, particularly developing countries where the testing markets are highly
fragmented and less mature.
Healthcare Information Technology. We empower healthcare organizations and clinicians with information
technology solutions that can improve patient care and medical practice. We develop differentiated products that
are designed to support the creation and management of patient records, by bringing together, in one patient-
centric view, information from various sources, including physician’s records and laboratory and hospital data.
We believe that these products enhance the value we provide to our customers and result in increased customer
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