The in vitro diagnostic test can deliver molecular results from whole blood samples in less than three hours, the company said.
The Simplexa VZV Swab Direct runs on the firm's Liason MDX instrument and has also been submitted to the US Food and Drug Administration.
The assay is based on the company's AmpiProbe technology, which uses fluorescent reporter-labeled primers and quencher-labeled primers to amplify DNA.
The agency has approved the use of Exact's Cologuard test for average-risk individuals aged 45 and older.
The blood test screens individual blood donations for four common species of the parasite Babesia, which can cause anemia and other potentially fatal conditions.
The industry organization issued a letter urging the agency to reconsider recent decisions to demand several laboratories stop offering pharmacogenetic testing.
The Radiance platform uses laser force cytology technology to measure optical and fluidic forces within a microfluidic channel for cellular analysis.
The test detects 20 common viruses and bacteria that cause upper respiratory infections using the firm's high-throughput, automated MDx-3000 instrument.
The clearance of the Binx io CT/NG test marks a milestone for the Johns Hopkins University group that funds early-stage development of rapid STI testing.
The SuperExtract 32 with the SuperExtract Viral Mag NA Purification kit provides high-quality purification of hepatitis and HIV viral nucleic acid.
Beyond its HostDx Sepsis test, the firm is working on a test to detect and differentiate bacterial from viral infections in patients presenting with fever.
Industry players, faced with vague communications from the agency, scramble to decipher regulatory expectations and criticize the agency for trying to control PGx knowledge.
The NAM, NAS, and Royal Society have formed a commission to develop a framework on the proper use of genome editing, and convened its first meeting in Washington, DC, this week.
The firm said its platform provides sample-to-answer results for two of the most frequently tested sexually transmitted infections, enabling rapid testing and treatment.
The company is on track to submit Guardant360 to the FDA in the third quarter, but also expects to see pan-cancer reimbursement much sooner.
The test will be used to identify which metastatic, castration-resistant prostate cancer patients harbor germline BRCA mutations and will likely benefit from Lynparza.
Filter tips for use with QiaSymphony SP/AS instruments may leak, which could lead to delayed or inaccurate results and cause serious injury or death.
Temple City, California-based Fulgent offers genetic tests for a range of diseases and disorders, as well as custom panels and sequencing services.
The regulatory approval means that the assay for minimal residual disease is available to monitor B cell blood cancers in patients in all 50 states.
NeuMoDx's tests are designed for central laboratory use and run on the company's fully automated NeuMoDx 96 or 288 real-time PCR systems.
GenomeWeb reports that Veritas Genetics is suspending its US operations.
A Brazilian-led team of researchers reports it has generated a sugarcane genome assembly that encompasses more than 99 percent of its genome.
Certain plasma proteins could be used to gauge a person's age and whether they are aging well, according to HealthDay News.
In Science this week: approach to measure microRNA targeting efficiency, strategy to conduct high-throughput chemical screens at single-cell resolution, and more.