DRG submits new automated reader for FDA clearance

Sept. 13, 2012

The DRG:Hybrid-XL, a fully automated, random access analyzer, has been CE cleared and is in the process for FDA approval. The company hopes to introduce it to the international market in late November. Its technology allows the simultaneous measurement of immunoassays and clinical chemistry parameters, including turbidimetric tests from one sample. Additionally, the DRG analyzer can detect analytes in serum, plasma, urine, or saliva.

This benchtop analyzer is designed to serve medium-sized and small laboratories and provide diagnostic services to hospitals, clinics and large medical practice facilities. In smaller labs, the Hybrid-XL can analyze both immunodiagnostic parameters and clinical chemistry tests which would otherwise require two separate instruments. In addition, the construction of the analyzer allows the flexibility to combine diagnostic panels that can run simultaneously. Up to 20 patient samples can be analyzed in one run with up to 40 tests of different types, such as gynecology, oncology, pre-natal supervision, cardiac markers, thyroid function, endocrinology, and infectious diseases.

The Hybrid-XL is designed to provide ease of use. It is controlled by an easy-to-read touch screen monitor run by software that offers simple user navigation. STAT function allows new samples to be added during a run with prioritization. Depending upon the test type, the results can be read in as little as 10 minutes.

Currently DRG is validating a wide range of possible tests for use in a variety of areas of medical expertise. The first available panels will include 25-OH Vitamin D, 17-OH Progesterone, DHEA-S, Renin, Aldosterone, DHEA, Estradiol, Cortisol, Cystatin-C, and HbA1c, among others. Read MLO’s interesting Executive Snapshot of DRG’s CEO and president Cyril Geacintov, PhD.