PHENOPATH LABORATORIES INTRODUCES KRAS TESTING FOR COLORECTAL TUMORS

January 23, 2009

Seattle, WA --- PhenoPath Laboratories, a national anatomic pathology reference laboratory providing a wide range of diagnostic testing and consultative services to clinicians, announced that it is introducing KRAS testing for patients diagnosed with colorectal cancer.

According to the American Cancer Society, colorectal cancer is the third most common cancer in both men and women in the U.S. with an estimated 108,000 new cases diagnosed in 2008 alone. Because colon or rectal cancer can have little or no symptoms, many patients have progressed to an advanced, metastatic disease before they are diagnosed.

KRAS mutation status is a key predictor in patient responsiveness to anti-EGFR antibody therapy. Testing for the presence of mutations in the KRAS gene (present in 30-40% of colorectal adenocarcinomas) has become a critical and essential step in determining which patients will benefit from the addition of cetuximab (Erbitux™) therapy.

"We are very excited about the introduction of the KRAS test since our goal is to bring the best quality results to clinicians working with patients facing difficult decisions in treatments," said Allen M. Gown, M.D., Chief Pathologist and Medical Director. "Unlike other ARMS-based mutational assays, the design of our assay employs direct visualization of mutant and control KRAS gene PCR products, which decreases the likelihood of false positive results and facilitates our expedient turn-around time."

Of all known KRAS mutations, 99.5% have been identified in human cancers involving codons 12 and 13 of KRAS. In the assay developed and validated at PhenoPath Laboratories and designed to perform optimally in deparaffinized, formalin-fixed tissue, these KRAS mutations are detected by the allele-specific PCR method (Amplification Refractory Mutation System [ARMS]). The high sensitivity of PhenoPath Laboratories' ARMS assay for KRAS means that mutations can be detected even if the mutated tumor accounts for only 1% of the specimen.

Slides from every case sent to PhenoPath Laboratories are scrupulously reviewed by one of their Pathologists to ensure that the most appropriate portions of the tissue are analyzed, resulting in fewer-quantity-not-sufficient (QNS) results.

About PhenoPath Laboratories

Seattle-based PhenoPath is a national anatomic pathology reference laboratory committed to the highest quality, rapid, state-of-the-art testing for cancer diagnosis. PhenoPath provides diagnostic services including flow cytometry, immunohistochemistry and molecular testing to hospitals, physician's offices and research institutions nationwide. Additional information can be found on PhenoPath's web site at www.phenopath.com, or by contacting Doug Sites, Director of Sales and Marketing, at 206.374.9000.