FDA Nod for Gen-Probe's PROGENSA - Analyst Blog
February 17 2012 - 11:45AM
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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