FDA Nod for Gen-Probe's PROGENSA - Analyst Blog
February 21 2012 - 1:21PM
Zacks
Diagnostic products maker Gen-Probe Inc. (GPRO)
has secured the approval of the U.S. Food and Drug Administration
("FDA") for its PROGENSA PCA3 assay, a novel molecular test
designed to aid the diagnosis of prostate cancer.
The assay is geared for testing urine specimens from men who
earlier had a negative prostate biopsy.
Gen-Probe submitted a Pre-market Approval (“PMA”) application to
the FDA for PROGENSA PCA3 in September 2010. The California-based
company, in November 2011, said that it received a notice from the
FDA that stated the regulator had concluded that a panel
review was no longer necessary in the review process of the
PMA. The panel review was expected in October 2011.
Gen-Probe acquired the exclusive global rights to the PCA3 (a
genetic marker for prostate cancer) from Canadian cancer diagnostic
tests company DiagnoCure in November 2003. The PROGENSA PCA3 assay,
the first urine-based molecular diagnostic assay for prostate
cancer, is currently marketed in the European Union and Canada.
Prostate cancer is the second most prevalent cancer (after skin
cancer) among American men and the second-leading cause (after lung
cancer) of cancer-related death. According to the American Cancer
Society (ACS), roughly 241,000 people were diagnosed with prostate
cancer in the U.S. in 2011 and around 34,000 of them succumbed to
the disease.
The PROGENSA PCA3 assay detects the presence of cell-associated
PCA3 in urine. PCA3 is over-expressed in 90% of prostate tumors
(quantifiable in urine samples) and predicts biopsy results better
than traditional prostate-specific antigen (PSA) testing, as
observed in clinical studies. The assay is expected to help reduce
unnecessary repeat prostate biopsies in men who have had at least
one previous negative biopsy.
Gen-Probe has been a pioneer in the commercial and scientific
development of nucleic acid testing (“NAT”) for the diagnosis of
infectious diseases. It competes with larger, more established
players in the molecular diagnostic industry such as
Roche (RHHBY), Becton Dickinson
(BDX), and Abbott Labs (ABT).
Gen-Probe is a leading pure-play molecular diagnostics company.
The company’s molecular diagnostic tests and instruments are
designed to improve results and increase laboratory operating
efficiency.
Molecular testing enables real-time detection of the primary
cause of a disease at the molecular level. Gen-Probe is positioned
to benefit from the ongoing market shift away from traditional
diagnostic methods (such as antibody-based assays) toward molecular
testing, which offers greater precision and sensitivity in
detecting biological events.
Gen-Probe’s clinical diagnostics business posted healthy results
in the most recent quarter with revenues soaring nearly 13% year
over year. The company expects double-digit organic sales and
earnings growth in 2012 riding on new product launches (including
PROGENSA PCA3). We are currently Neutral on the stock, backed by a
short-term Zacks #3 Rank (Hold).
ABBOTT LABS (ABT): Free Stock Analysis Report
BECTON DICKINSO (BDX): Free Stock Analysis Report
GEN-PROBE INC (GPRO): Free Stock Analysis Report
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