Roche launches additional test for improved management of epithelial ovarian
Automated assay offers efficient testing, expands company's tumor marker
portfolio on integrated platforms
INDIANAPOLIS, Nov. 12, 2012
INDIANAPOLIS, Nov.12, 2012 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY)
announced today the U.S. market availability of the Elecsys HE4 assay, an FDA
approved test used in monitoring patients with ovarian cancer. The HE4 test is
used as an aid in monitoring the recurrence or progressive disease in patients
with epithelial ovarian cancer.
Studies like K Huhtinen et al (2009) show that HE4 shows a high specificity to
ovarian cancer over that of CA 125 alone. Both HE4 and CA 125 together, rather
than either of them alone, provides a more accurate tool for differential
diagnosis of patients with ovarian cancer and ovarian endometriotic cysts from
"As a leader in oncology, Roche is committed to providing reliable tests that
will enable physicians to deliver the best possible care to their patients,"
said Randy Pritchard, vice president of marketing at Roche Diagnostics
Corporation. "The addition of the Elecsys HE4 assay further strengthens our
tumor biomarker menu and means healthcare providers now have another tool to
give them greater confidence in monitoring patients with ovarian cancer."
About the Test
The Elecsys HE4 assay is an immunoassay for the quantitative determination of
HE4 in human serum and plasma. The assay is used as an aid in monitoring the
recurrence or progressive disease in patients with epithelial ovarian cancer.
Serial testing for patient HE4 assay values should be used in conjunction with
other clinical findings used for monitoring ovarian cancer. The immunoassay is
intended for use with Roche's electrochemiluminescence (ECL) technology, a
highly sensitive light detection system that provides excellent low-end
sensitivity and broad dynamic measuring ranges. The test is approved for use
on the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and MODULAR
ANALYTICS E170 analyzers.
About ovarian cancer
Ovarian cancer is the fourth most common cause of cancer-related death in
women worldwide. It is the most lethal form of gynecological cancer, and
potentially curable if diagnosed early and treated by surgeons familiar with
the management of ovarian cancer. However, the symptoms of ovarian cancer are
related to the presence of adnexal masses and are often vague and unspecific.
Thus 70-75% of ovarian cancers are detected at a late stage. According to the
International Agency for Research on Cancer, the 5 year survival rate of
ovarian cancer patients is 46%. However, if the disease is diagnosed early,
the survival rate increases up to 94%.
Headquartered in Basel, Switzerland, Roche is a leader in research-focused
healthcare with combined strengths in pharmaceuticals and diagnostics. Roche
is the world's largest biotech company with truly differentiated medicines in
oncology, virology, inflammation, metabolism and CNS. Roche is also the world
leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer
in diabetes management. Roche's personalized healthcare strategy aims at
providing medicines and diagnostic tools that enable tangible improvements in
the health, quality of life and survival of patients. In 2011, Roche had over
80,000 employees worldwide and invested over 8 billion Swiss francs in R&D.
The Group posted sales of 42.5 billion Swiss francs. Genentech, United States,
is a wholly owned member of the Roche Group. Roche has a majority stake in
Chugai Pharmaceutical, Japan. For more information: www.roche.com or
All trademarks used or mentioned in this release are protected by law.
For further information, please contact:
Director, Corporate Communications
Roche Diagnostics Corporation
SOURCE Roche Diagnostics
Press spacebar to pause and continue. Press esc to stop.