Foundation Medicine's liquid biopsy test will be used in the third stage of SCRUM-Japan, which focuses on advanced cancer patientsin Japan and other Asian countries.
The company also inked a deal with an investment bank to publicly offer from time to time up to $4.2 million of its stock.
The company filed the application based on the PAOLA-1 data, which showed HRD-positive ovarian cancer patients saw pronounced benefit from the combo.
The company said the funding will support international expansion of its FebriDx rapid point-of-care test and its US clinical trial.
The EUA allows the test to be used at all CDC-qualified labs in the US on patients who meet CDC criteria for testing for the coronavirus.
If granted, emergency use authorization is anticipated to help roll out standardized, consistent 2019-nCoV testing to public health labs in the US.
The FDA has been prodding labs performing pharmacogenetic testing, and software firms providing reports from such testing, to undergo regulatory review.
The diagnostic firm has agreed with Streck to incorporate its blood collection tubes into sample collection protocols for its genomic lung cancer tests.
The agency said it believes its recent focus on the issue has tamped down on genetic testing fraud, though it expects new questionable arrangements will emerge.
The Access PCT assay can help clinicians assess patients in danger of severe sepsis or septic shock and delivers results in less than 20 minutes.