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The company's test uses self-collected saliva samples from potential parents to assess their future child's genetic predisposition to various diseases.
Under the Ge-Med project, University Hospital Tübingen will offer diagnostic whole-genome sequencing for all genetic indications and will include PRS in its reporting.
Vikor has invested an undisclosed amount to help the startup commercialize a direct-to-consumer service that includes genomic risk testing and liquid biopsy cancer screening.
Later this year, the inherited cardiovascular disease clinic also plans to implement a preventive genomics program with polygenic risk score and PGx testing.
The Helix Laboratory Platform is the first whole-exome sequencing platform to receive do novo authorization by the agency and paves the way for others.
During a session at the ASHG 2020 virtual meeting, representatives from both organizations laid out the reasons for their contrasting guidelines.
The LUNGevity Foundation and 41 stakeholders aim to reduce cancer patients' confusion about in vitro diagnostic testing by implementing two consistent umbrella terms.
Results from the PROMPT registry presented at ASCO showed that 10 to 15 percent of women with variants in genes not linked to ovarian cancer had oophorectomies.
The company will offer a 32-gene polygenic score test to patients in the Osaka, Japan Nakanoshima Clinic, with reporting and patient support help from IxLayer.
The agency compiled the evolving list by drawing on information from drug labeling and the published literature and is asking stakeholders to provide feedback.