Abbott wins FDA nod for cancer, prenatal Dx

Abbott won FDA approval for a new diagnostic used on its Architect analyzers.--Courtesy of Abbott

Abbott Laboratories ($ABT) may face a rocky FDA road for its MitraClip device, but the company won agency approval for a new molecular diagnostic that can help detect testicular cancer and prenatal problems.

The Architect AFP test tracks the biomarker alpha-fetoprotein, which can indicate the presence of birth defects in unborn children and plot the progression of testicular cancer in men, Abbott says.

The protein builds up in a mother's amniotic fluid when a child's neural tube fails to close properly, and prenatal testing can help determine whether a baby will be born with defects like anencephaly and spina bifida.

Similarly, men with a type of testicular cancer called nonseminoma germ cell have elevated levels of the protein in their blood, and Abbott's diagnostic can help physicians determine whether patients are responding to therapy, the company said.

"The Architect AFP assay is a valuable tool that will help physicians obtain reliable measurements of this protein for use in guiding critical patient treatment decisions," Abbott Diagnostics VP Brian Blaser said in a statement. "Abbott is pleased to offer this important assay to our customers to positively affect patient care."

The new test runs on Abbott's fleet of Architect analyzers, screening for alpha-fetoprotein levels in blood, plasma and amniotic fluids.

Now that Abbott has cleaved off its innovative drug business, the company is looking to expand its diagnostics business. Last quarter, Abbott posted 3.8% revenue growth in core lab diagnostics and a 14.7% sales jump for its on-the-rise point-of-care unit. The company has also stepped up its companion diagnostics presence, signing deals with fellow giants Johnson & Johnson ($JNJ) and Pfizer ($PFE) to provide tests for pipeline drugs.

- read Abbott's announcement

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