Throughout 2025, ELITechGroup MDx continued to support the needs of clinical and research laboratories amid uncertain regulatory changes after the publication of the FDA’s LDT Final Ruling. The FDA has since sent notice rescinding the Laboratory Developed Test (LDT) Final Rule in 2025.
ELITechGroup MDx –A Bruker Company as of Jan. 1st, 2026 has designed, developed, and released to market 13 new reagents optimized for high throughput applications, expanding our existing portfolio of PCR reagents designed to support laboratories develop their own assays.
Each new release high throughput or “HT” reagent suite features primer chemistry modifications optimized for high throughput systems and a Duplex Stabilizing Quencher, or DSQ probe. Our HT reagents are optimized for use on the utility channel of open real-time PCR platforms.
In 2018, ELITechGroup MDx patented the Duplex Stabilizing Quencher (DSQ), a hybrid structure which simplifies labeled oligonucleotide chemistry, to combine the function of a MGB and a fluorescence quencher. DSQ probes allow for the design of significantly shorter oligonucleotide probes with the same melt temperature (Tm) ranges as traditional longer probes, increasing probe specificity.
The DSQ Alert® product line is built on our proprietary DSQ probe chemistry. The DSQ was designed to possess long-range and broad spectrum fluorescence quenching abilities to retain the breadth of compatible fluorophores and the multiplexing capacity of an azo dye quencher.
High Throughput Reagent Portfolio
CATALOG # | PRODUCT NAME |
M400857±
| DSQ Alert® HT Parvovirus B19 Detection Reagent |
M400858±
| DSQ Alert® HT Adenovirus Detection Reagent |
M400865±
| DSQ Alert® HT HSV 1&2 Detection Reagent |
M400866±
| DSQ Alert® HT HHV-6 A&B Detection Reagent |
M400923±
| DSQ Alert® HT Pneumocystis jirovecii Detection Reagent |
M800760§
| DSQ Alert® HT Candida auris Primer Mix |
M800761§
| DSQ Alert® HT Candida auris Probe Mix |
M800811§
| DSQ Alert® HT HDV Primer Mix |
M800812§
| DSQ Alert® HT HDV Probe Mix |
M800813§
| DSQ Alert® HT JCV Primer Mix |
M800814§
| DSQ Alert® HT JCV Probe Mix |
M800815§
| DSQ Alert® HT HAV Primer Mix |
M800816§
| DSQ Alert® HT HAV Probe Mix |
M800819§
| DSQ Alert® HT Norovirus GI Primer Mix |
M800820§
| DSQ Alert® HT Norovirus GI Probe Mix |
M800821§
| DSQ Alert® HT Norovirus GII Primer Mix |
M800822§
| DSQ Alert® HT Norovirus GII Probe Mix |
M400971±
| DSQ Alert® HT JCV Detection Reagent |
M400972±
| DSQ Alert® HT Mycoplasma-Ureaplasma Detection Reagent |
M400974±
| DSQ Alert® HT Legionella Detection Reagent |
§Analyte Specific Reagent. Analytical and performance characteristics are not established.
‡For Research Use Only. Not for use in diagnostic procedures.
*Sold separately.
Each reagent by ELITechGroupMDx – A Bruker Company is as follows:
- ASR§ is a mix of primers or probes optimized via insilico analysis for target amplification and identification.
- RUO± is provided as a mixture of amplification reagents specific to each of the target pathogens, and to a synthetic sequence to serve as an internal control to monitor assay performance. Probes are labeled with FAM or an AquaPhluor® fluorophore and a DSQ quencher, to enable detection and distinction of each target in the multiplex.
- RUO± is designed to be combined with a master mix containing the necessary components for PCR.
- Manufactured in-house at our cGMP-compliant, ISO
13485-certified facility
Our reagents are optimized to support molecular labs to develop assays using real-time PCR across a wide range of clinical and research applications.
We understand what is at stake – timely detection of pathogen targets can be critical for labs amid evolving regulatory and epidemiological needs. At ELITechGroup MDx — A Bruker Company, we are leaders in providing innovative diagnostic solutions to laboratories nationwide. With decades of experience in the industry, our mission is to empower labs with the tools and knowledge they need to deliver accurate, reliable, and timely diagnostics. We are committed to supporting our partners through every regulatory change, ensuring that patient care remains at the forefront of everything we do.