Xenomics, Inc. and Its Subsidiary TrovaGene, Inc. Announce HPV Patent Filing Based on Transrenal DNA Technology
November 10 2009 - 6:30AM
Business Wire
Xenomics, Inc. (XNOM.PK), a developer of transrenal molecular
diagnostics, announced today that it has filed a patent application
on novel technology for the detection of Human Papilloma Virus
(HPV) DNA, based on Xenomics transrenal DNA technology. The
technology would be applied to urine-based HPV screening.
“The HPV patent will be a valuable addition to Xenomics’s
extensive transrenal DNA/RNA patent portfolio,” commented Bruce A.
Huebner, CEO of Xenomics. “The HPV market offers our business a
large market opportunity and is one of our leading product
development priorities. Our plan is to develop a wide range of
tests that utilize our patented urine-based transrenal DNA/RNA
technology which include assays to detect mutations in solid tumor
cancers and organisms that cause infectious diseases. We will
pursue a combined collaboration and development strategy which
includes identifying corporate partners in Japan and Europe, while
Xenomics focuses on development of products for the North American
market.”
At present, about 55 million Pap smears and 10 million HPV tests
are performed annually in the US. The U.S. market for HPV tests,
about $240 million in 2008, is growing at a rate of 20% to 40%
annually. This market is currently dominated by Qiagen®
(Nasdaq:QGEN), Hologics (Nasdaq: HOLX), Roche (RHO5:GR) with the
expected entry of Gen-Probe® (Nasdaq: GPRO) in the near future. The
market is projected to continue to experience rapid growth based
upon more market awareness after the introduction of the HPV
vaccine, Gardasil®, which was developed by Merck & Co. (NYSE:
MRK).
The TrovaGene HPV DNA test involves isolation of DNA from urine
and specific PCR amplification of the HPV E1 region to detect the
presence of high-risk HPV types. In a recent study presented at the
2009 ASCO meeting, results were compared to the hc2 High-Risk HPV
DNA Test® (QIAGEN®). Of 320 patients tested, 248 samples (77.5%)
were concordant between the TrovaGene and hc2 assays. Using DNA
sequencing as the gold standard, the TrovaGene test had a
Sensitivity of 93.0% and a Specificity of 96.0%. In comparison, the
hc2 assay has a reported Sensitivity of 93.0% and a Specificity of
61.1%. These initial data indicate superior performance for the
TrovaGene assay to the current market leading assay.
The hc2 and other HPV tests that are currently available all
rely on cervical scraping in female patients or swabbing of the
penile urethra in males. The TrovaGene HPV DNA test needs only a
urine sample and can be used to screen both males and females.
Recent information suggests that testing males will help to better
control the spread of this virus.
About Xenomics, Inc. and TrovaGene TM, Inc.
The company has focused on the development of DNA and RNA-based
tests using Trans-renal DNA (Tr-DNA) or RNA (Tr-RNA). Its patented
technology uses safe and simple urine collection and can be applied
to a broad range of applications, including tumor detection and
monitoring, infectious disease detection, prenatal testing, tissue
transplantation, genetic testing for forensic identity
determination, drug development, and research to counter
bioterrorism. Its TrovaGene, Inc. subsidiary was formed principally
to provide a mechanism to change the company’s corporate domicile
from Florida to Delaware and the company’s corporate name by
statutory merger. The company’s founding scientists were the first
to report that fragments of DNA from normal cell death cross the
kidney barrier and can be detected in urine. The company believes
that its technology will open significant new markets in the
molecular diagnostics field. The company has been issued three U.S.
patents covering different applications of the technology for
molecular diagnostics and genetic testing and a European patent for
the company's prenatal testing applications, as well as numerous
pending patent applications.
Statements about the company's expectations, applications of its
technology, markets, and other statements that are not historical
facts are "forward-looking statements" within the meaning of
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 and are based on management's
current beliefs, assumptions, estimates and projections. Actual
results may differ materially from those projected in the
forward-looking statements for various reasons, including risks
associated with product development, government regulation, market
acceptance, dependence on key personnel, obtaining financing and
other factors.