Clarient Launches New Lung Cancer Test

ALISO VIEJO, Calif., Feb. 10 /PRNewswire-FirstCall/ -- Clarient, Inc. (Nasdaq: CLRT), a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced the commercial launch of a new lung cancer test, Clarient Insight® Dx Pulmotype® Test, that helps physicians classify specific types of lung cancer to identify which therapies may be most effective. The new test has been clinically validated to use in the sub-classification of patients with non-small cell lung cancer (NSCLC), which accounts for approximately 85 percent of the more than 200,000 lung cancer cases diagnosed each year.

"Pulmotype provides pathologists with a valuable new tool to help their oncologist clients understand which patients are eligible for a number of new therapies now available for the treatment of NSCLC," said Chief Executive Officer Ron Andrews. "Its ability to accurately sub-classify lung cancer will enable physicians to make much more informed and effective therapy decisions. We have built a very strong breast cancer franchise and established Clarient as the 'go-to' laboratory for complex breast cancer testing. Pulmotype allows us to offer a similar compelling reason for pathologists and oncologists faced with critical decisions in lung cancer to send the primary tumor samples to Clarient.  Having the lung cancer sample in our hands at the beginning of the diagnostic process allows us to assist the pathologist and the oncologist throughout the patient care process by delivering information on additional molecular markers, such as EGFR mutation and KRAS."

The Pulmotype test consists of a panel of biomarkers that allows physicians to classify NSCLC into adenocarcinoma or squamous cell carcinoma subtypes, which are key distinctions in choosing the most effective therapy. Newly developed targeted therapies can be very effective but can also be very toxic depending on the patient and his or her disease characteristics.

"Given the types of therapies on the market today, the kind of information generated from a panel like Pulmotype can make a big difference in how a patient is treated," said Ken Bloom, M.D., Chief Medical Officer for Clarient. "The correct pathology assessment is essential for therapeutic decision making, given the powerful new drugs currently on the market to treat lung cancer, such as Avastin® and Alimta®. The use of these therapies is predicated on the histologic differentiation of the cancer into categories such as non-squamous NSCLC cancer or squamous NSCLC, which are classifications that Pulmotype can help provide. Furthermore, the power to identify patients with adenocarcinomas in non-small cell lung cancers also promotes finding patients that also harbor EGFR mutations, which have been shown to predict response to a number of tyrosine kinase inhibitors.  We believe this test will quickly demonstrate its value as a critically important tool in the assessment of lung cancer."

Clarient Insight Dx Pulmotype is the first commercial test launched following the Company's recent acquisition of Applied Genomics Inc. (AGI). AGI developed Pulmotype and recently validated the test with a clinical study cohort of more than 1,000 patients. The peer-reviewed results were published in the August 2009 edition of Modern Pathology.  A link to that study can be accessed at www.clarientinc.com/pulmotype.

Ron Andrews continued, "The combination of Pulmotype and EGFR should differentiate Clarient from its competitors and could become a key driver of revenue growth. Our goal is to be the first place a pathologist goes after diagnosing NSCLC. Having a primary diagnostic test like Pulmotype on our menu should help us capture a growing number of lung cancer tumor specimens for initial testing. In addition, Pulmotype can identify the cancers that will benefit from knowing the EGFR mutation status, which should strengthen our ability to gain a greater share of the fast-growing EGFR mutation test market. The validation and launch of Pulmotype within eight weeks of closing the AGI acquisition is a testimony to Clarient's ability to rapidly integrate technology into its lab operation and commercialize a new complex cancer diagnostic."  

About Clarient Insight® Dx Pulmotype® Test

Clarient Insight Dx Pulmotype test is a five antibody immunohistochemistry (IHC) test that can be used to aid in the histological distinction between adenocarcinoma and squamous cell carcinoma in NSCLC tumor specimens. The histologic classification of non-small cell lung tumors has gained clinical relevance because newly developed targeted therapies show different clinical effectiveness or toxicity dependent upon the histology of the tumor. There is currently no other widely accepted molecular-based tool to help distinguish the different histological types.

The Pulmotype test was developed with a 551 patient surgical specimen lung carcinoma retrospective cohort and was validated on three independent cohorts in more than 1,000 clinical cases. Pulmotype can play an immediate role for pathologists in complementing the morphological assessment of lung types resulting in a more accurate diagnosis and more informed therapeutic decisions.

About Clarient

Clarient combines innovative diagnostic technologies with world-class pathology expertise to assess and characterize cancer. Clarient's mission is to become the leader in cancer diagnostics by collaborating with the healthcare community to translate cancer research and development into better patient care.  Clarient's principal customers include pathologists, oncologists, hospitals and biopharmaceutical companies. The rise of individualized medicine has created the need for a centralized resource which provides leading oncology diagnostic technologies, such as flow cytometry and molecular testing. Clarient is that resource, having created a state-of-the-art commercial cancer laboratory, which provides advanced oncology testing and diagnostic services.  Resulting diagnostic reports and analyses are made available to customers through Clarient's Internet-based portal, PATHSiTE™.  Clarient also plans to develop and market new, proprietary "companion" diagnostic markers for therapeutics in breast, prostate, lung and colon cancers, and leukemia and lymphoma. www.clarientinc.com

Forward Looking Statements

Certain statements herein regarding Clarient, Inc. contain forward-looking statements that involve risks and uncertainty. Future events and Clarient's actual results could differ materially from the results reflected in these forward-looking statements. Factors that might cause such a difference include, but are not limited to: Clarient's ability to continue to develop and expand its diagnostic services business, uncertainties inherent in Clarient's product development programs, Clarient's ability to expand and maintain a successful sales and marketing organization, Clarient's ability to obtain additional financing on acceptable terms or at all, uncertainty of success in identifying and developing new diagnostic tests or novel markers, Clarient's ability to fund development of new diagnostic tests and novel markers and the amount of resources Clarient determines to apply to novel marker development and commercialization, failure to obtain FDA clearance or approval for particular applications, Clarient's ability to compete with other technologies and with emerging competitors in novel cancer diagnostics and dependence on third parties for collaboration in developing new tests, Clarient's ability to successfully integrate AGI's operations, Clarient's ability to successfully validate and commercialize AGI's product offerings, Clarient's ability to successfully launch its lung cancer test, Pulmotype®, in the first quarter of 2010, and risks detailed from time to time in Clarient's SEC reports, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K.

Clarient does not assume any obligation to update any forward-looking statements or other information contained in this document.

SOURCE Clarient, Inc.