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CombiMatrix Launches Two New Array-Based Diagnostic Tests

CombiMatrix Corporation announced today the launch of two new array-based diagnostic tests, adding to its leading and growing portfolio of tests. These new tests augment each other and demonstrate levels of multiplexing and personalization that are unprecedented in the industry. The tests will be operated out of its wholly owned laboratory in Irvine, California, CombiMatrix Molecular Diagnostics.

The first test is an update of the Bac HD Scan 2500(tm) to the Bac HD Scan 2700(tm) test, which will now and furthermore be referred to as the "Bac HD Scan(tm)" test. The previous version of this test was designed to identify up to 125 genetic syndromes and disorders that are the cause of developmental problems in children. Some of the syndromes identified by this test include Down (Trisomy 21), Prader-Willi, Smith Magenis, Trisomy 13, Trisomy 18, and DiGeorge Syndromes, to name just a few. The newly launched, updated version of this test now increases the number of specific genetic syndromes tested for, to over 220. Moreover, because of the whole-genome coverage of this array, numerous clinically relevant non-syndromic genomic abnormalities can also be simultaneously identified. This level of multiplexing has never been demonstrated before in any diagnostic situation.

"The speed with which CombiMatrix has been able to expand the capability of this test again underscores the flexible and adaptable nature of our technology," stated Dr. Mansoor Mohammed, President and CEO of CombiMatrix Molecular Diagnostics. "We will continue to update our tests as more genetic information and knowledge becomes available in this rapidly advancing field. Our goal is to remain at the forefront of translational genomics and personalized diagnostics to provide the very best and clinically prudent tests for our patients and physicians."

In addition to the new Bac HD Scan test, an additional product -- the Zoom-in(tm) array test -- has been launched. This test is used in conjunction with CombiMatrix's other array tests to provide an even higher-resolution sequence analysis of the genetic aberration in question. In many cases, while identifying the initial genetic aberration is valuable for patient management, finding specific detail about the exact site of the aberration, the size, the extent, and sequence, can provide even more value for the attending physician and, ultimately, for the patient. Our previously launched tests are specific array designs that analyze a patient's genome to identify genetic factors that enable personalized medical decisions. Each of these arrays is the same for all patients, and the analytical information is the personalized result. The Zoom-in test is an array that is uniquely, and individually, designed and built for each patient. Upon identification of a genomic aberration or aberrations with one of our current array tests, a new array is built using CombiMatrix's CustomArray(r) 12K(tm), which is designed to interrogate the aberration with the power of 12 thousand customizable oligonucleotide probes. The probes are designed such that they "zoom in" specifically on the aberrant areas, providing unprecedented resolution in those areas. The ability to build this new array on demand, in a time-expedient manner consistent with diagnostic expectations, is unique to CombiMatrix by virtue of its bench-top CustomArray B3 Synthesizer(tm). In this mode, the Zoom-in test enables the creation of a unique array for EVERY SINGLE patient. This level of personalization has never been achieved before and is at the forefront of genomic medicine. As an example, once a patient has been evaluated with Bac HD Scan test, or any of CombMatrix's other diagnostic arrays, a physician can now order the Zoom-in test to gain an unprecedented understanding of the genomic cause of the disease or disorder. It must be noted that the Zoom-in test is the first and ONLY array motif that allows a physician to achieve clinically relevant high-genome resolution, in a patient-specific manner, without the concerns of the surplus of genomic information that plagues other ultra-high-density oligo-array platforms.

Dr. Amit Kumar, President and CEO of CombiMatrix noted, "Our continued innovation of array-based genetic testing is enabling approaches to patient management that is unsurpassed. We have built the broadest portfolio of array-based diagnostics by far. In fact, our portfolio includes more diagnostic tests than the sum of tests from all array companies combined. We are extremely proud of this achievement and hope to maintain our lead. In addition to these products, we have committed to the launch of a prostate cancer test by the end of this year, and shortly we will disclose and discuss another revolutionary product that is currently in the R&D pipeline."

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