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CombiMatrix Molecular Diagnostics Launches Next Version of Its Constitutional Genetic Array Test and With It Enters the Prenatal Market

Posted on: Tuesday, 20 March 2007, 06:00 CDT

Acacia Research Corporation (Nasdaq:CBMX) (Nasdaq:ACTG) announced today that its CombiMatrix group's subsidiary, CombiMatrix Molecular Diagnostics (CMDX), has completed the clinical validation of and has launched the second version of its Constitutional Genetic Array Test (CA850). The test utilizes the company's new Bacterial Artificial Chromosome (BAC) array, which includes over 200 new, validated probes obtained through the company's partnership with The Center for Applied Genomics, in Toronto, Canada. The CA850 array now has the most comprehensive and robust clinically validated genomic coverage in the industry. The CA850, which can identify over 50 common genetic disorders in one test, has now been clinically validated for use in both postnatal and prenatal analyses by CMDX.

In postnatal settings, over two thirds of young children with developmental disorders are either undiagnosed or misdiagnosed through conventional techniques. Limitations due to the genomic resolution of conventional methods, as well as the burdensome necessity of performing these methods in a serial fashion, largely account for this unacceptable standard. The CA850 provides a cost and time-effective approach to simultaneously and accurately identify the specific genomic aberrations associated with the most common genetic developmental disorders. In addition, it provides the industry's most comprehensive genomic "backbone" coverage to facilitate the detection of spurious genomic aberrations, which account for a significant share of children with developmental disorders.

In prenatal settings, for a large number of pregnancies, amniocentesis followed by karyotyping is a common method to evaluate the genetic health of the fetus. The CA850 provides a more rapid initial screen than traditional karyotyping as it precludes the need for metaphase chromosome preparations. When used responsibly with traditional karyotyping, CMDX believes that there could be a large market for the CA850 in prenatal testing. By providing an initial more rapid and comprehensive analysis of the genomic health of the developing fetus, CMDX's CA850 is especially relevant with the increasing trend of couples to conceive later in life, where the risk of genetic abnormality can be significantly elevated.

Additionally, CMDX is working on techniques that would allow use of the CA850 in the growing market of in vitro fertilization (IVF). In an IVF clinic, a physician typically selects embryos for implantation into the mother's womb from among several candidates. These are implanted as 8-16 cell embryos. Use of the CA850 would allow prospective parents to be more certain of the embryo's genetic health prior to implantation and would give them and their physicians a powerful tool in the selection of embryos from among the candidates for implantation. The challenge for CMDX is that only a small number of cells, often 1 or 2, can be safely removed from each embryo for analysis while maintaining acceptable viability of the embryo. Also the result has to be obtained rapidly, as the embryo's viability is reduced significantly with time. CMDX is evaluating advanced amplification methods that would allow rapid array CGH protocols appropriate for use in an IVF setting.

Also, as announced recently, in a future version of its constitutional genetic array test, CMDX anticipates the ability to stratify patients diagnosed with autism, in a way that may help predict future clinical course. These studies are ongoing, and we hope to provide updates shortly. The key point is that CMDX is able to launch products and to refine versions of products rapidly as new knowledge of the genome becomes available.

"Our CA850 array detects the most common major genomic disorders and provides significantly enhanced coverage of the entire genome," said Dr. Mercedes Gorre, VP of Scientific Affairs at CMDX. "This serves the dual purpose of, first, providing superior genome-backbone coverage resulting in improved data integrity and quality, and second, enables the detection of unexpected copy-number changes at loci not normally covered in other BAC arrays. We have begun to differentiate ourselves by rapidly designing and validating genomic coverage that is the most comprehensive in the industry, and I firmly believe the full benefit of this transformative technology will be realized by this approach to array design."

"Late last year, with the launch of our first CA650 array-CGH test, I indicated that within 18 months our plan was to have the industry's broadest portfolio of array-based diagnostic tests. Now, in less than 9 months, with the launch of our HemeScanTM and our CA850 test, we are well on our way to exceeding our goals," said Dr. Amit Kumar, President and CEO of CombiMatrix Corporation and Chairman of CMDX. "Also, I am excited about the possibilities for the CA850 in prenatal as well as postnatal testing. As a parent myself, I can see enormous value in the ability for a parent to get such thorough information about a child's potential genetic well-being."

According to Dr. Eric Vilain, MD, Ph.D., Chief of Medical Genetics in the Department of Pediatrics at the UCLA Medical Center and Director of Sexual Medicine, Department of Urology, UCLA, "CMDX has demonstrated its notable ability to bring on new content and quickly produce timely and clinically relevant BAC array tests. I look forward to the latest version of their congenital array."

ABOUT TCAG

The Centre for Applied Genomics (TCAG; www.tcag.ca) is a core infrastructure within the Research Institute at The Hospital for Sick Children, Toronto, Canada, and is a Science and Technology Platform for the Ontario Genomics Institute and Genome Canada. TCAG's mandate includes the provision of genomics research infrastructure and resources for investigators in the public, private and government/NGO sectors worldwide. Additionally, TCAG provides consultative resources related to genomics project design, data generation and analysis. Dr. Steve Scherer is the Scientific Director of TCAG and is a world-renowned researcher in the areas of genomic variability and the genetics of autism and related neurodevelopmental disorders. For a detailed biography, see www.tcag.ca/scherer/.

ABOUT ACACIA RESEARCH COPORATION

Acacia Research Corporation comprises two operating groups: Acacia Technologies Group and CombiMatrix Group.

The CombiMatrix group is developing a platform technology to rapidly produce customizable arrays, which are semiconductor-based tools for use in identifying and determining the roles of genes, gene mutations and proteins. The CombiMatrix's group's technology has a wide range of potential applications in the areas of genomics, proteomics, biosensors, drug discovery, drug development, diagnostics, combinatorial chemistry, material sciences and nanotechnology.

The Acacia Technologies group develops, acquires, and licenses patented technologies. Acacia controls 63 patent portfolios covering technologies used in a wide variety of industries including audio/video enhancement & synchronization, broadcast data retrieval, computer memory cache coherency, credit card fraud protection, database management, data encryption & product activation, digital media transmission (DMT®), digital video production, dynamic manufacturing modeling, enhanced Internet navigation, image resolution enhancement, interactive data sharing, interactive television, laptop docking station connectivity, microprocessor enhancement, multi-dimensional bar codes, resource scheduling, spreadsheet automation, and user activated Internet advertising.

Acacia Research-Acacia Technologies (Nasdaq:ACTG) and Acacia Research-CombiMatrix (Nasdaq:CBMX) are both classes of common stock issued by Acacia Research Corporation and are intended to reflect the performance of the respective operating groups and are not issued by the operating groups.

Information about the Acacia Technologies Group and the CombiMatrix Group is available at www.acaciaresearch.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995:

This news release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These statements are based upon our current expectations and speak only as of the date hereof. Our actual results may differ materially and adversely from those expressed in any forward-looking statements as a result of various factors and uncertainties, including the economic slowdown affecting technology companies, our ability to successfully develop products, rapid technological change in our markets, changes in demand for our future products, legislative, regulatory and competitive developments and general economic conditions. Our Annual Report on Form 10-K, recent and forthcoming Quarterly Reports on Form 10-Q, recent Current Reports on Forms 8-K and 8-K/A, and other SEC filings discuss some of the important risk factors that may affect our business, results of operations and financial condition. We undertake no obligation to revise or update publicly any forward-looking statements for any reason.

Source: Business Wire

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