Diagnostics & Imaging Week

CombiMatrix Molecular Diagnostics (Irvine, California) has launched a new test that discriminates malignant melanoma from benign moles.

The test, based on the CustomArray platform from CombiMatrix (Mukilteo, Washington), is a molecular diagnostic tool designed to enable pathologists to resolve difficult-to-diagnose cases through an objective genetic analysis.

The test was formally introduced to the melanoma community at the 10th Anniversary Benefit of the William S. Graham Foundation for Melanoma Research (Hayward, California) held in San Francisco on Saturday.

CombiMatrix is the corporate sponsor for this event and a corporate sponsor for the organization.

"In this particular case for the melanoma test, it analyzes genes that we have identified that will indicate whether a cell or a group of cells — the tissue — is melanoma, where melanoma is concerned, or if it's malignant," Dr. Amit Kumar, president/CEO of CombiMatrix, told Diagnostics & Imaging Week. Kumar also is chairman of CombiMatrix Molecular Diagnostics.

The test is a microarray, a chip with a sequence of DNA on it, and the company has established a "multiple gene expression signature" that can determine if a mole is benign or malignant.

Kumar said that in current practice, a dermatologist might examine a mole and send a specimen to a lab for pathology assessment. While some cases of melanoma are obvious and easy to diagnose, other cases are not so clear-cut and therefore hard to diagnose. That, in turn, can lead to misdiagnosis — either as a case of diagnosing tissue as cancerous, that is not actually malignant, or ignoring a mole that later turns out to be malignant.

If someone is misdiagnosed as having melanoma, it can lead to toxic chemotherapy treatments. In the opposite case, it can lead to death if the melanoma is left to metastasize.

"This exciting new test represents a breakthrough in the field of dermatology," said Scott Binder, MD, professor of clinical pathology and dermatology, chief of dermatopathology, and senior vice chairman at the David Geffen School of Medicine at UCLA (Los Angeles).

"As a dermatopathologist I am often called upon to make very difficult decisions regarding whether or not a patient has malignant melanoma, particularly after traditional laboratory methods have failed to provide a clear diagnosis. This test from CombiMatrix Molecular Diagnostics provides me with a powerful new tool to help resolve many of these tough cases."

Matt Watson, CEO of CombiMatrix Molecular Diagnostics, said, "This is the second microarray service that we have launched in as many calendar quarters, and it is only the first in a broad menu of array-based cancer tests that we hope to release in the near future."

Last month, Acacia Group (Newport Beach, California), the parent company of CombiMatrix, reported that CombiMatrix had received a letter from the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD) regarding its Constitutional Genetic Array Test (CGAT). The FDA determined that the test does not require FDA approval under the draft guidance the agency put forth for public comment earlier this year regarding what it called In Vitro Diagnostic Multivariate Index Assay (IVDMIA).

The CGAT, which uses blood samples rather than tissue samples, as in the melanoma test, is designed to identify common genetic disorders that result in developmental anomalies in children.

So, as Kumar told D&IW, "All of our tests are launched as laboratory tests," and they fall under Clinical Laboratory Improvements Amendments (CLIA) guidelines.

CombiMatrix said that in July, the OIVD requested a meeting with CombiMatrix to discuss the regulatory status of the CGAT, which the company had planned to launch —and ultimately did launch — in September. CGAT was the company's first commercially launched array-based molecular diagnostic test.

"And, as appropriate, we will meet with the FDA to tell them more about [the melanoma test] if they feel they want to look at it. But we feel, again, that it does not fall under the IVDMIA guidelines," Kumar said.

"Melanoma is the fastest growing cancer in the United States, and like most cancers early identification and detection is an important factor in survival. We are encouraged that this new test is now available to physicians and patients in our battle against this often fatal disease," said Karen Graham, the founder and chairperson of the William S. Graham Foundation for Melanoma Research. "I founded the William S. Graham Foundation in honor of my son, Billy, who died as a result of the misdiagnosis of melanoma. Had this test been available then, the outcome might have been different."

Acacia Research comprises two operating groups, Acacia Technologies group and CombiMatrix group.

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