The company is also looking to expand the use of its FDA-approved ClonoSeq assay, which has US FDA approval for MRD detection in acute lymphocytic leukemia and multiple myeloma.
In a recent study, researchers found that a PSA SNP variant affected protein stability, activity, and glycosylation, and could impact clinical measurements.
The firm's new RT-PCR assay identifies 20 gene fusion between NTRK1/2/3 and other genes, allowing clinicians to potentially detect rare forms of different cancers.
The firm's fourth quarter preliminary revenues increased by 11 percent to $865 million year over year, while full-year revenues jumped by 21 percent to $3.3 billion.
The tests are designed to detect genetic variations including SNPs, insertion-deletions, copy number variations, and variations in segmental duplications.
CEO Kim Popovits discussed three strategic imperatives for the coming year: increasing penetration in established markets, broadening global access, and continuing to diversify its portfolio.
Japan's Nichirei will register Biocartis' Idylla MDx oncology products with the Japanese Ministry of Health, Labor and Welfare.
The company said it completed approximately 292,000 Cologuard tests during the fourth quarter.
The firms will partner on studies needed to support and secure US regulatory approval for the Elio tissue complete assay.
In a letter to CMS, AMP made a case for crosswalking existing CPT codes for BRCA1/2 testing to codes that more accurately reflect the work required to analyze these genes.
Veracyte plans to launch a new version of its Percepta test and present data for a nasal swab lung cancer diagnostic this year.
PGDx and KingMed plan to provide tumor mutational burden testing to pharmaceutical companies for clinical trials in China and Hong Kong.
Research groups and companies are developing and applying tools to enrich for and capture CTCs to diagnose tumors early and monitor patients during treatment.
The team will combine CellMax's circulating tumor cell platform and Medigen's liquid biopsy panel to track treatment response in colorectal cancer patients.
The firm is moving into a larger facility after its first full year of profitability and planning new hires to support its plans to bring liquid biopsy kits through the FDA.
The firm has struggled in the past to convince payors of its test's clinical utility but remains dedicated to convincing the field that Epi proColon can help patients by closing CRC screening gaps.
Foundation Medicine's assay detects genomic alterations in 324 cancer genes and serves as a companion diagnostic for patients with certain types of tumors.
Excluding IPOs, the funding environment for private venture-backed financing Dx deals in the US and Europe was remarkably similar in 2018 to 2017, according to Silicon Valley Bank.
New drugs, tests, and policies suggest steady and continued future growth in the space, though public awareness of personalized medicine continues to lag.
The assay uses a genomic DNA signature called the metastatic potential score derived from copy number alteration analysis of specific regions of the genome.