The firm has provided glimpses into its strategies for developing a line of regulated droplet digital PCR tests in a number of recent forums.
The test uses droplet digital PCR to detect BCR-ABL gene fusions and is intended for treatment response monitoring of chronic myeloid leukemia.
The team has developed a method to test for inherited disorders prenatally and plan to conduct a larger trial and eventually offer it as a clinical test.
Third quarter sales of $535.0 million beat analysts' average estimate of $508 million and represented 3 percent growth on a currency-neutral basis.
The firm has not published validation studies for the test, but new data last week has provided more support for the methylation-based method at its heart.
Gencurix's assay can be used to select which non-small cell lung cancer patients will respond to tyrosine kinase inhibitors.
The sales decline was largely due to a slowdown in productivity related to the recent launch of the company's global enterprise resource planning system in Western Europe.
Clinicians say they are using blood-based tests for patients who can't be biopsied as a way to get test results sooner, but implementing tests smartly and appropriately remains a challenge.
The test, which detects DNA methylation markers, is being developed as an alternative to invasive cystoscopy, the current standard of care.
New data points to strong predictive ability for a ddPCR-based test of AR copy number, while other companies are pursuing tests that target expression of AR splice variants.