regulatory approval
Precipio Hematologic Malignancy Test Receives NY State Approval
The Hemescreen test uses proprietary high resolution melt technology and can now be used in labs in New York as a laboratory developed test.
Pillar Biosciences Receives FDA Approval for OncoReveal Dx Lung and Colon Cancer Assay
The IVD, intended for use on the Illumina MiSeq Dx, detects somatic mutations in tumor tissue samples to guide the use of anti-EGFR therapy where indicated.
Hologic Receives CE Mark for Molecular Test to Quantify Cytomegalovirus
The assay, which quantifies the human cytomegalovirus viral load in transplant patients, represents a new market opportunity for Hologic's MDx business.
Guardant Health Receives New York State Approval for Guardant Reveal MRD Test
The assay is Guardant Health’s first commercially available product for clinical management of early-stage tumors and is initially focused on colorectal cancer.
Delfi Diagnostics Starts Prospective Lung Cancer Screening Trial
The company is planning to commercialize its cancer early detection technology initially in lung cancer and is working with NYU researchers to explore future expansions.