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More than 70 percent of labs surveyed experienced supply chain interruptions, forcing them to validate three or more diagnostic testing methods.
The company enters a race to the clinic with several direct competitors, including Guardant Health and CellMax Life, as well as other firms pursuing multi-cancer screening.
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's adaptive low-resource testing technology requires no instrumentation and limited equipment, making it adaptable to settings without clinical lab infrastructure.
The template describes the data and information that should be submitted for EUA of collection kits or tests with a home self-collection component.
The company said that by the end of June it would have made available more than 500,000 kits, which allow individuals to self-collect nasal samples at home.