The company reported no revenues in Q3 but said it has completed the transition to a new diagnostic platform for its DetermaVu liquid biopsy lung cancer test.
The assay can identify KRAS, NRAS, PIK3CA, BRAF, and EGFR gene mutations, as well as 19 gene rearrangements of the ALK, ROS1, RET, NTRK1, and MET genes from FFPE.
The firm said genomic testing volume rose 23 percent year over year, and raised its revenue guidance for full-year 2018.
Biomatrica's sample collection tubes ensure quality preservation of circulating tumor DNA and cells, promoting high-quality liquid biopsy results, Exact said.
The firm's Cell-CT platform takes photos of an epithelial cell spinning through a microfluidic tube to produce a 3D image to find defects linked to lung cancer.
Becton Dickinson got clearance for a platform and test for the rapid identification and determination of antimicrobial susceptibility of gram-negative bacteria.
Precision Pathology will develop the CyPath Lung test for early-stage detection of lung cancer as an LDT for commercial sale by the first-quarter of 2019.
The technology uses a conducting polymer-based electrochemical chip with an array of electrodes and employs an electrical field to release and detect mutations.
The measures are part of a long-term plan for the National Health Service that will be rolled out across the country to detect 3 out of every 4 cancers at an early stage.
The new approval will allow the use of Qiagen's Therascreen EGFR RGQ PCR Kit as a companion diagnostic for Pfizer's Vizimpro in NSCLC patients.