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The company expects to garner clearance for its platform in the US first for Lynch syndrome as it builds additional evidence for an immunotherapy application.
In an interview, Marilyn Li and Douglas Stewart discuss why ACMG has put forth points that doctors and labs should consider when presumed germline findings crop up in tumor testing.
The diagnostic will be covered when patients are tested according to the Japanese Organization of Hereditary Breast and Ovarian Cancer's criteria.
The company believes results from a new study help demonstrate the clinical value of its targeted RNA-seq method, an add-on to its DNA hereditary cancer tests.
The company attributed its revenue shortfall to billing issues in the prenatal testing business and announced that CFO Bryan Riggsbee will be interim CEO.
Paired tumor/germline analysis is not routinely done in cancer care, but some labs are starting to report incidental germline findings alongside patient's tumor profiles.
Doctors can now order the test to identify breast cancer patients with BRCA1/2 mutations who may be eligible for surgery or targeted therapy.
The firm generated $56.5 million in revenue compared to $37.4 million in Q3 2018, and beat the consensus Wall Street estimate of $55.0 million
The company had a challenging fiscal first quarter due to the deletion of CPT codes that payors used to use to reimburse hereditary cancer testing.
CMS has attempted to address stakeholders' concerns about its coverage criteria for germline NGS testing in a new proposed national policy.