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The firm initially plans to apply the method, which measures the size of specific macrophages in blood, to predict lung cancer immunotherapy response.
The agency said that KBMO has promoted a serology test based on the use of a dried blood spot kit that it offered to send to patients' homes.
Burning Rock also said it will continue to develop companion diagnostics-related products based on next-generation sequencing technology.
The test detects IgG antibodies and has confirmed 100 percent sensitivity and nearly 100 percent specificity, according to the company.
The test is based on the US Centers for Disease Control and Prevention's SARS-CoV-2 panel and detects two regions of the virus' nucleocapsid gene.
FBB Biomed, cofounded by a diagnostics industry veteran, is attempting to develop a blood RNA test to predict COVID-19 disease severity.
Both tests are authorized for use by any laboratory CLIA certified to perform high-complexity tests, according to the FDA.
The Energy and Commerce Committee chairman asked the agency to show Congress all of the state and local plans for COVID-19 testing by July 6.
The investment bank said CareDx's products are gaining traction and that the stock is positioned for 20 percent to 30 percent growth over the next few years.
The firm used the new loan to pay off an older $7.0 million loan and a $3.0 million promissory note held by Qiagen North American Holdings.
For the three months ended March 31, the firm reported revenues of $9.2 million, up from $6.0 million in the year-ago quarter and beating the consensus Wall Street estimate of $8.9 million.
The firm said that its RAQ SARS-CoV-2 PCR Kit allows the replacement of full nucleic acid extraction with a simple heat treatment, decreasing sample processing time.
Both PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in upper respiratory specimens and may only be performed by their developers.
Chembio suggested a device modification could improve performance, following an analysis of troubling NCI data. The FDA didn't agree.
Recent guidance from HHS has improved data collection by clarifying which testing data all laboratories must report, including demographic data.
The firm's SmartChip platform consists of a high-throughput liquid dispenser and a PCR instrument and can provide more than 5,000 reactions in one run.
The cancer molecular diagnostics firm said it will use the proceeds from the offering to support its R&D activities and for general corporate purposes.
The two PCR-based tests are designed to detect SARS-CoV-2 nucleic acid in respiratory samples including nasopharyngeal swabs and bronchoalveolar lavage specimens.
Babson recently signed an agreement to provide SARS-CoV-2 serology testing services for a study being conducted at the University of Texas at Austin.
University of Oxford said the program will assemble experts with experience in generating the robust evidence required for a test to be used in the UK NHS.