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The company will issue units representing an aggregate of shares of common stock and warrants to purchase stock shares at an aggregate purchase price of $5.72.

The company, which had received a request from the FDA for more information on the test, is planning additional studies before resubmitting the application.

PreludeDx's DCISionRT test is for women diagnosed with ductal carcinoma in situ or stage 0 breast cancer who are treated with breast-conserving surgery.

The company has performed 100,000 rapid tests for SARS-CoV-2 to date for a variety of organizations, including sports leagues and public schools.

The agency cautioned test companies that the presence of mutations in the virus could lead to false negative results.

Advanced NSCLC patients must have a PD-L1 expression tumor proportion score of 50 percent, and no EGFR, ALK, or ROS1 alterations, to receive the drug.

LightDeck said it is developing a six-minute test to offer better performance than current lateral flow tests that need 15 minutes or more to return a result.

The test, developed at George Mason, measures HER2 activation in a breast cancer biopsy to help determine if a patient will respond to treatment.

Piper Sandler analyst Steven Mah noted that Ortho's installed base of more than 20,000 instruments provide it with 93 percent recurring revenue.

A BD lateral flow antigen test will be paired with the Scanwell Health mobile app for home use and public health results reporting.