An Agilent Complementary Diagnostics Test is Approved for Melanoma

I previously blogged about Agilent’s work with immunotherapy drugs, which use the body’s own immune system to fight disease.  Dako, an Agilent Technologies company, developed the first complementary diagnostics approved to support the use of Bristol-Myers Squibb’s OPDIVO® for non-squamous non-small cell lung cancer.

That diagnostic assay, Dako PD-L1 IHC 28-8 pharmDx, has now been approved by the U.S. Food and Drug Administration to include patients with melanoma.

Melanoma is the least common but most deadly skin cancer, accounting for about 2 percent of all cancer cases.  It is almost always curable in its early stages, but much more likely to spread to other parts of the body than other skin cancers.  Melanoma is most often caused by ultraviolet radiation from the sun or tanning beds.  The DNA in skin cells becomes damaged, causing mutations and malignant tumors.

Dako’s complementary test may be used by physicians to determine the status of PD-L1, a protein that can suppress the body’s immune system.

“We are truly excited about the FDA’s approval of the PD-L1 test for use in melanoma in addition to the lung indication we received last year,” says Agilent’s Jacob Thaysen.  “We are the first company providing FDA-approved tests for lung cancer and melanoma for PD-L1 markers.”


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