HER2 CISH Gene Amplification Test Now Available
Invitrogen Corporation, (NASDAQ:IVGN), a provider of essential life
science technologies for research, production and diagnostics,
has signed an exclusive U.S. distribution agreement with Biocare Medical
LLC, a leading provider of immunohistochemistry reagents, multiplex
stains, and automated platforms for the anatomic pathology market, for
the new SPOT-Light® HER2 CISH Kit. The kit
received U.S. Food and Drug Administration premarket approval in July,
(click here
for release), as an aid in the assessment of breast cancer patients for
whom trastuzumab (Herceptin®) treatment is
being considered.
Approximately one million people worldwide are screened each year for
HER2 amplification or over-expression. The importance of genetic tests
like HER2 CISH is growing because some targeted cancer therapies (like
trastuzumab) are most effective in patients who overexpress the HER2
gene. The primary users will be pathologists, oncologists, and
histotechnologists who will determine the best course of treatment for
breast cancer patients. The SPOT-Light® test
uses standard histology laboratory methods and equipment to yield
valuable gene status information.
“We are pleased to bring this kit to market so
quickly after receiving FDA approval,” said
Brett Williams, head of Invitrogen’s
Anatomical Pathology Business. “Working with
the Biocare sales force, we believe we will be able to more rapidly and
efficiently deliver this critical diagnostic product to clinicians who
are making life-saving decisions for their breast cancer patients.
“Biocare’s rapid
growth has been fueled by providing award winning technical and customer
service in addition to novel products for anatomic pathology and
research laboratories,” said Roy Yih, Biocare
Chief Executive Officer. “We are enthusiastic
about being selected as the exclusive U.S. distribution channel for the
SPOT-Light HER2 CISH Kit. This product is the first FDA approved product
to provide the confidence and objectivity of in-situ hybridization with
the ease of immunohistochemistry, enabling a wider number of anatomic
pathology laboratories to perform this critical test.”
Per FDA requirements, laboratories must be certified prior to purchasing
the SPOT-Light® HER2 CISH Kit for use on
patient specimens. One user per laboratory must successfully complete
Invitrogen’s HER2 CISH certification program.
Full certification details are available at www.invitrogen.com/her2cishcert.
