Leading medical diagnostics/research company announced today exclusive
distribution agreement with AsymmetRx, Inc. for the only FDA cleared, patented
test to diagnose prostate cancer
DEDHAM, Mass., Feb. 21 /PRNewswire-FirstCall/ -- Signet Laboratories,
Inc., today announced the signing of an agreement with Connecticut-based
AsymmetRx, Inc. providing exclusive distribution of their patented, FDA 510(k)
cleared Prostate-63 (IVD) Prostate Cancer Diagnostic Test Kit using p63. The
new kit, jointly developed and exclusively marketed by Signet Laboratories, is
the only FDA cleared prostate cancer diagnostic test kit. It is the first in a
series of kits that uses p63 to diagnose prostate cancer.
AsymmetRx, Inc. holds the exclusive, worldwide license under the Harvard
Medical School patent filings (including U.S. Patent 6,946,256) for the use of
p63 antibodies to diagnose prostate and other cancers, and has recently
received 510(k) clearance from the FDA for the use of p63 as an IVD (In Vitro
Diagnostic) test to aid pathologists in diagnosing prostate cancer. The p63
gene was discovered in the Harvard lab of AsymmetRx founder Dr. Frank McKeon
and the p63 prostate cancer diagnostic test was invented by a collaboration of
labs at Harvard and Harvard-affiliated hospitals.
Maria McKeon, AsymmetRx's President & CEO said, "Prostate cancer is one of
the most difficult cancers to diagnose from biopsied material, and the p63-
based test adds a significant advantage to making a correct diagnosis. This
kit ushers in the only FDA cleared prostate cancer test, which aids
pathologists in the differential diagnosis of prostate cancer in conjunction
with morphological findings. Numerous articles in top clinical journals have
cited the accuracy and utility of p63 for prostate cancer diagnosis." Paul
Fluckiger, Signet's President & COO stated, "This is an exciting and important
opportunity for both of our companies to embark on the development of a series
of kits that provide improved diagnostics for prostate cancer patients. We
are both committed to the provision of only the highest quality solutions for
affected patient populations."
The p63 protein is a member of the p53 family, which also includes p73,
and is expressed in the nucleus of basal cells in the epithelium. Markers of
basal cells are useful in diagnostic pathology particularly when examining
difficult prostate biopsies. Because p63 is localized to the nucleus of
cells, it can offer distinct advantages over cytoplasmic labeling. The
Prostate-63 Prostate Cancer Diagnostic Test Kit features a mouse monoclonal
antibody, clone 4A4, that recognizes the human p63 protein in the nucleus of
prostatic basal cells and urothelial tissues (Yang et al., 1998; Signoretti et
al., 2000).
About Signet Laboratories, Inc.
Signet Laboratories, Inc. (Dedham, MA), is a leading medical
diagnostics/research company specializing in the development of monoclonal
antibodies and diagnostics assays for cancer, infectious disease, and
neurodegenerative disease. Signet was created in 1989 as a commercial spinout
of Johnson & Johnson's Cambridge Research Laboratories, Inc. (Cambridge, MA).
The Company was founded to continue the mission originally established at
CRL -- the early detection and recurrence monitoring of patients with cancer
and infectious disease. Signet has developed patented technology for diagnosis
and recurrence monitoring and for risk assessment of asymptomatic patients in
these areas. For more than a decade, the Company has aggressively maintained
licensing and development programs, which are responsible for its broad patent
and intellectual property estate.
About AsymmetRx
AsymmetRx, Inc. was founded in 2001 by scientists from Harvard University
and Johns Hopkins University to develop novel diagnostics, imaging agents, and
therapies for urologic cancers including those affecting the bladder and
prostate. Using strategies based on key advisors from private and academic
clinicians and pathologists specializing in urologic cancers, AsymmetRx is
committed to developing the most accurate tests for the analysis of prostate
and bladder biopsies, as well as early detection tests that in the future will
obviate the need for needle biopsies.
AsymmetRx is committed to developing systems of imaging urologic cancers
that will aid in the early treatment of such diseases, as well as therapies
based on specific targeting of malignant cells in urologic cancers.
AsymmetRx recently succeeded in developing the first FDA cleared test for
prostate cancer in needle biopsies based on the p63 antibody. It is
anticipated that the p63-based test will assist in the accurate diagnosis and
treatment of hundreds of thousands of men in the United States alone. More
detailed information on the company and its mission may be found at
http://www.asymmetrx.com.
Contact Information
Signet Contact AsymmetRx Contact
Colleen Scott Maria McKeon, Esq.
Signet Laboratories, Inc. AsymmetRx, Inc.
180 Rustcraft Road 117 Senate Brook Drive
Dedham, MA 02026 Amston, CT 06231
Phone: 781.915.1404 Phone: 860-716-8888
Fax: 781.461.2456 Fax: 203-413-4333
cscott@signetlabs.com mckeon@asymmetrx.com
SOURCE Signet Laboratories, Inc.
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Related links:
http://www.signetlabs.com
http://www.asymmetrx.com
CONTACT:
Colleen Scott of Signet Laboratories, Inc.,
+1-781-915-1404, cscott@signetlabs.com; or Maria McKeon, Esq., of
AsymmetRx, Inc., +1-860-716-8888, mckeon@asymmetrx.com
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