Abbott Announces New Testosterone Test to Measure the Hormone at Low Levels

 Abbott Announces New Testosterone Test to Measure the Hormone at Low Levels

New Assay Measures Testosterone Levels to Help Diagnose Related Conditions in
Both Men and Women

PR Newswire

ABBOTT PARK, Ill., Dec. 17, 2012

ABBOTT PARK, Ill., Dec. 17, 2012 /PRNewswire/ --Testosterone is an important
androgen hormone in the health and well-being of men and women. Testosterone
levels are associated with sexual development, libido, protection against
osteoporosis, and cardiovascular health. In men, insufficient testosterone
levels (hypogonadism) have been linked to obesity and low libido. In women,
polycystic ovary syndrome (PCOS) is a common endocrine disorder that can
result in excessive production of testosterone, leading to infertility,
irregular or absent menstrual periods, and hirsutism (excess body and facial
hair). Inappropriate testosterone levels can also result in precocious or
delayed puberty. The measurement of testosterone plays an important part in
the diagnosis of many conditions and it can guide treatment decisions.

Published studies have shown, however, that many currently available
testosterone tests are not sensitive enough to measure low levels of
testosterone. This limits the clinical utility of these tests. To address this
need and help physicians accurately measure the wide range of testosterone
levels seen in men and women, Abbott announced today clearance from the U.S.
Food and Drug Administration for a new testosterone test.

"The ARCHITECT 2^nd Generation Testosterone Assay is more sensitive, accurate
and precise than previous versions of the assay," said Frank Quinn, PhD, FACB,
director of Global Scientific Affairs for Endocrinology, Abbott."The improved
assay performance means physicians will be able to obtain more reliable
measurements of testosterone and use this information to help guide patient
treatment decisions."

The new assay runs on Abbott's fully-automated ARCHITECT family of analyzers
and is available in the United States, as well as in several European
countries, Asia Pacific, Latin America, Japan, Africa, the Middle East, and
India, pending country registration.

Intended Use
The ARCHITECT 2^nd Generation Testosterone Assay is a chemiluminescent
microparticle immunoassay for the quantitative determination of testosterone
in human serum and plasma. Measurements of testosterone are used in the
diagnosis and treatment of disorders involving:

  oThe male sex hormones (androgens) including primary and secondary
    hypogonadism, delayed or precocious puberty, and impotence in males; and
  oIn females, hirsutism (excessive hair) and virilization (masculization)
    due to tumors, polycystic ovaries, and androgenital syndromes.

For complete information, see the assay-specific product information on

About Abbott ARCHITECT
Since the introduction of the ARCHITECT i2000, Abbott has developed and
launched a series of ARCHITECT analyzers that are delivering flexibility,
automation, and convenience to today's clinical laboratory. The first truly
integrated portfolio of immunoassay and clinical chemistry instruments,
ARCHITECT offers more than 170 assays and has features that minimize training
and reduce inventory, which result in improved performance and outcomes for
laboratories and physicians.

About Abbott Diagnostics
Abbott is a global leader in in vitro diagnostics and offers a broad range of
innovative instrument systems and tests for hospitals, reference labs,
molecular labs, blood banks, physician offices, and clinics. With more than
22,000 customers in more than 100 countries, Abbott's diagnostic products
offer customers automation, convenience, bedside testing, cost-effectiveness,
and flexibility. Abbott has helped transform the practice of medical diagnosis
from an art to a science through the company's commitment to improving patient
care and lowering costs.

About Abbott
Abbott (NYSE: ABT)is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The company
employs approximately 91,000 people and markets its products in more than 130

Abbott's information and news releases are available on the company's Web site


Contact: Media, Darcy Ross, +1-847-937-3655, or Jessica Masuga,
+1-847-935-0650, or Financial, Tina Ventura, +1-847-935-9390
Press spacebar to pause and continue. Press esc to stop.