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droplet digital PCR

The firm plans to add more oncology tests, NIPTs and newborn screening assays through in-house development and partnerships with third-party assay makers.

The test is for monitoring treatment response in chronic myeloid leukemia and uses a new Droplet Digital PCR instrument.

The approach could allow doctors to more accurately and more easily identify which patients are free from cancer after radiation treatment.

The company is collecting validation evidence it intends to submit to the FDA next year, which will also support launch of  the test as an LDT.

The company said Q2 sales increased 11 percent on a currency-neutral basis, driven by growth in both its Life Science and Clinical Diagnostics segments.

Bio-Rad tallied net sales of $551.5 million compared to $500.1 million in Q1 2017, driven by growth in both its Life Science and Clinical Diagnostics businesses.

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.

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