CombiMatrix, Clarient To Market Novel Genomics-Based Test For Chronic Lymphotic Leukemia

Chronic Lymphotic Leukemia

CombiMatrix, Clarient to market, sell a novel genomics-based cancer test called HemeScan, a comprehensive test related to the treatment and care of chronic lymphocytic leukemia, among other cancers. The HemeScan test was developed by CombiMatrix and validated in collaboration with a team of high-profile academic centers, including the M.D. Anderson Cancer Center in Houston, the University of Texas Health Science Center in San Antonio, and Netherlands Cancer Institute in Amsterdam.

"The HemeScan test has proven to be a valuable and reliable clinical tool for the management of hematological malignancies (leukemia and lymphomas) and solid tumors characterized by unbalanced chromosomal rearrangements," said Shelly Gunn, M.D., Ph.D., Medical Director of Combimatrix Molecular Diagnostics (CMDX), a subsidiary of CombiMatrix Corporation. "Along with CLL, the HemeScan test has also been clinically validated for acute lymphoblastic leukemia (ALL) and myelodysplastic syndrome (MDS) and is currently being tested for multiple myeloma (MM)."

"The HemeScan test will be marketed by Clarient to pathologists, oncologists, and patients," said Mansoor Mohammed, Ph.D., President and CEO of CMDX. "In choosing our first partner to market our transformative HemeScan test, we felt that Clarient's cancer-focused brand is an ideal fit. Clarient is a nationally recognized cancer diagnostic service laboratory and deploys an expert national sales force with strong relationships with community pathologists and oncologists. We are pleased to have such a preeminent partner market our product and aid in its wide-scale adoption."

The HemeScan test is a comprehensive test enabling prognosis at the time of diagnosis in the treatment and care of CLL patients. The test provides prognostic marker precision with simultaneous diagnostic monitoring of the entire genome in CLL.

"The HemeScan test's technology represents a more precise platform adding greater granularity to assist local pathologists and oncologists in the molecular assessment of this complex disease," said Ken Bloom, M.D., Clarient's Chief Medical Officer. "The traditional cytogenetic test used currently does not reliably give us the information we need to take advantage of the therapeutic capabilities available today. Transitioning the industry to more sophisticated technologies undoubtedly will be a major step in providing personalized therapy for individual patients."

Clarient President and CEO Ron Andrews added that he expects that the HemeScan test will help drive the growth of the Company's hematopathology business. "We are pleased to add CMDX's HemeScan test to our growing portfolio of novel tests and we believe this test will strengthen the competitive positioning of our hematopathology service offering," Andrews noted. "Our leukemia and lymphoma business line is growing nicely as Clarient continues to adopt innovative technologies and tools to assist local pathologists and oncologist as they manage this disease. We look forward to working with CombiMatrix to support Clarient's growing lymphoma/leukemia business and as part of our continued focus on personalized medicine."

CLL is the most common form of the B-cell lineage lymphoproliferative disorders, accounting for about 30 percent of all cases in the USA and Europe. In the U.S. alone, there are greater than 10,000 new cases annually and over 150,000 patients living with the disease. CLL is a clinically heterogeneous disorder with defined risk groups associated with a full spectrum of patient prognostic outcomes. A growing appreciation of the latter has led hematopathologists and oncologists alike to adopt the term "prognosis at diagnosis" in regard to CLL.

The HemeScan test is an innovative approach to the management of CLL. In a single test, it assays all of the genomic loci for copy number aberrations currently measured by commercial multi-probe fluorescent in situ hybridization (FISH) kits. Moreover, by incorporating recently-identified genomic markers and a global genome perspective, the Companies believe the HemeScan test has the potential to have a transformative impact on the clinical stratification of CLL, enabling prognosis at diagnosis and patient-appropriate risk adapted treatment.