Laboratory Corporation of America Holdings
), or LabCorp has started offering
KRAS RGQ PCR Kit, a companion diagnostic test for certain
colorectal cancer patients, under the name KRAS Gene Mutation
Analysis, Colorectal Cancer (CRC).
This is the sole FDA-approved companion diagnostic for use
with ERBITUX (cetuximab), for patients with KRAS
mutation-negative (wild type) epidermal growth factor receptor
(EGFR)-expressing metastatic colorectal cancer. According to
KRAS test will help identify those patients who will be benefited
from treatment with ERBITUX.
An alarming number of 110,000 patients are detected annually
with advanced colorectal cancer in the U.S. With the majority of
them being KRAS-mutation negative (wild-type) and eligible for
ERBITUX therapy, this test is expected to play an important role
in the field of personalized medicine.
LabCorp is continuously striving toward a robust portfolio
expansion in order to drive its top line. This remains a part of
the company's 5-pillar strategy that states continued scientific
innovation to offer new tests at reasonable and appropriate
Apart from introducing this KRAS Gene Mutation Analysis in the
U.S. market, the company recently launched cobas EGFR Mutation
Test, a real-time PCR assay designed to detect deletion mutations
in exon 19 and the substitution mutation, L858R, in exon 21. The
cobas EGFR Mutation Test is used as a companion diagnostic for
Tarceva. According to LabCorp, the targeted population is likely
to experience greater clinical benefits compared with patients
treated with chemotherapy.
Moreover, over the next several quarters, LabCorp plans to
offer more comprehensive oncology panels that include additional
content covering liquid tumors, gene rearrangements and
prognostic and predictive markers. The product pipeline will also
comprise targeted tests such as a test for Lynch Syndrome - an
inherited genetic condition associated with increased risk of
colorectal cancer. Given the continuous focus on portfolio
expansion, we are confident about the company garnering higher
revenues from specialized testing, going forward.
However, challenging volume environments for testing
laboratories and utilization weaknesses across the healthcare
sector are major causes of concern. Further, margins continue to
remain under pressure. Although the company's share buyback
activity might provide some cushion, we remain watchful of the
poor bottom-line guidance for 2013 which implies that industry
trends are not expected to improve substantially in the
Accordingly, the stock carries a Zacks Rank #3 (Hold).
However, better-performing medical devices stocks such as
Align Technologies Inc.,
Mindray Medical International Ltd
), which carry a Zacks Rank #1 (Strong Buy), are worth
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