Asuragen said today that it has received US Food and Drug Administration clearance for its cGMP-manufactured sample collection and cellular RNA preservation device.
The device, called RNARetain, was first cleared by FDA in 2007 in conjunction with Agendia's MammaPrint breast cancer test.
RNARetain consists of an aqueous tissue preservation solution in a single-use vial for collecting, storing, and transporting breast tissue specimens for subsequent RNA isolation and molecular diagnostic testing, Asuragen said. The device eliminates the need for immediate processing of the tissue samples, and eliminates the need to flash-freeze samples and to keep them frozen throughout storage and transport.
The product also eliminates the need to preserve tissue in formalin, a hazardous material that is known to cross-link and degrade nucleic acids, compromising their use for molecular applications, Asuragen said.
Quest Diagnostics this week launched a renal transplant rejection test that it claims can help doctors determine if patients are rejecting their new kidneys "weeks before" clinical symptoms or other standard tests can detect such events.
Quest developed the laboratory test in collaboration with Beth Israel Deaconess Medical Center and Weill Cornell Medical College. The company claims that it is the first commercial molecular diagnostic for kidney transplant rejection.
The test is based on real-time PCR-based and gauges several RNA markers, including FoxP3, GZMB, and PRF1, which Quest exclusively licensed from Beth Israel and Weill.
In 2009, nearly 17,000 renal transplant procedures were performed, making the kidney the most routinely transplanted organ. However, based on 2010 figures from the US Organ Procurement and Transplantation Network and the Scientific Registry of Transplant Recipients, 70 percent of kidney transplants from a deceased donor fail within five years.
Current standard procedures for assessing whether a patient is rejecting a kidney transplant involve checking serum creatinine levels to gauge renal function and performing biopsies of the kidney, which can result in bleeding, graft injury, or loss, Quest said.
Meridian Bioscience subsidiary Bioline said this week that its Illumigene Group B Streptococcus test has received regulatory approval from the Therapeutic Goods Administration in Australia.
The test is based on loop-mediated isothermal DNA amplification technology and detects Streptococcus agalactiae from enriched cultures from vaginal swabs. Results can be achieved in less than an hour, Meridian said, adding that Group B Strep remains a major prenatal pathogen and is associated with significant morbidity and mortality in infants.
Meridian received US Food and Drug Administration approval of the test in December (PCR Insider, 12/15/2011).