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FDA submission

The Early Sepsis Indicator is intended to provide clinicians information about sepsis and the risk of developing sepsis in patients in acute care settings.

The company intends to use the funds to support submission of its NGS assay to the FDA, adoption of its testing by more health systems, and continued R&D.

Service revenues were down 8 percent year over year, product revenues grew 26 percent, and revenues from the transfer of intellectual property inched up less than 1 percent.

The company said it will seek FDA approval for the assay, an expanded version of FoundationACT, as a CDx for targeted therapies and as a tumor mutation profiling assay.

The company has also developed two liquid biopsy cancer test, Liquid GPS Core for DNA and Liquid GPS Expression for RNA.

JP Morgan healthcare conference opening

Among the diagnostic firms presenting at the conference on Tuesday were lab giant LabCorp, diversified medical products firm Hologic, and MDx startups, such as Adaptive Biotechnologies.

The company said that if it receives 510(k) clearance it will file a CLIA waiver, which would allow the test to be used at the point of care.

The final guidance is an update to an agreement between the FDA and CMS, which uses the FDA's policy in determining coverage for investigational devices. 

The company expects the new trials to start this fall, and plans to submit to the FDA next year to get the agency's stamp of approval.

The firm anticipates receiving regulatory approval from the CFDA for its first three products by the end of the year, including one for lung cancer.

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