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RNA-seq

The LCD will enable coverage of Envisia in patients for whom imaging does not lead to a definitive diagnosis of idiopathic pulmonary fibrosis.

The company posted $25.8 million in revenues for the quarter, up from $19.6 million a year ago, as total genomic test volume grew 28 percent to 9,154 tests.

The team plans to launch an RNA-seq diagnostic test out of the SickKids clinical laboratory in one year to complement clinical exome sequencing.

The company said RNA-seq will enable it to detect therapeutically relevant gene fusions better than DNA sequencing tests.

Veracyte plans to launch a new version of its Percepta test and present data for a nasal swab lung cancer diagnostic this year.

While the New York Genome Center says whole-genome cancer sequencing is the future, companies already offering such tests are struggling to get paid.

The company said that 20 medical centers in the US are now offering the Envisia Genomic Classifier through an early-access program begun in May.

The test is the first whole-genome-based cancer test to receive approval from New York State's Department of Health.

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.

Veracyte said that the draft policy is open to a 45-day comment period and could potentially go into effect in early 2019.

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