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Luminex Gets FDA Nod for ARIES MRSA Assay, Boosts Platform

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Luminex Corporation LMNX recently received a 510(k) clearance from the FDA for the ARIES MRSA Assay. The clearance reflects the company’s commitment toward the expansion of its portfolio of clinically relevant and high-value tests. These tests support patient care on sample to answer platforms globally.

Further, this FDA nod will provide a boost to the company’s ARIES system.

Staphylococcus aureus (MRSA): A Glimpse

Per the definition provided by Mayo Clinic, Methicillin-resistant Staphylococcus aureus (MRSA) infection is caused by a type of staph bacteria, which is resistant to many of the antibiotics utilized to treat ordinary staph infections.

Notably, MRSA infections are prevalent in people who have stayed in hospitals or other health care settings, such as nursing homes and dialysis centers. When it occurs under such a setting, it is known as health care-associated MRSA (HA-MRSA).

Further Details on ARIES MRSA Assay

The assay is a real-time, quantitative polymerase chain reaction (qPCR)-based, in vitro diagnostic test for direct identification of methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients who are at risk for nasal colonization.

Molecular tests such as these can potentially help physicians in controlling the spread of antimicrobial resistance and the connected negative outcomes for both patients and healthcare facilities. This in turn can lead to effective patient management by lowering unnecessary use of antimicrobial therapies.

Together with the company’s previously cleared ARIES difficile Assay, the recent clearance of ARIES MRSA Assay is likely to substantially lower healthcare acquired infections and improve patient care and outcomes considerably.

Luminex’s ARIES Platform Update

Luminex’s ARIES system — representing a major revenue opportunity for the company — has been making substantial progress. The company is focused on fortifying its market leadership in infectious disease with sample to answer platform, the ARIES system.

In fact, the company is about to complete its clinical study for Group A Strep, which would soon be submitted for review to the FDA.

Market Prospects

According to a report by MarketandMarkets, the global molecular diagnostics market is projected to reach $15.94 billion by 2027 from $8.38 billion in 2019 at a CAGR of 8.4%. High prevalence of infectious diseases and different types of cancers, advancements in molecular techniques, and rise in awareness and acceptance of personalized medicine and companion diagnostics are some of the key catalysts of this market.

Some other key players in the medical instruments space are Abiomed, Inc. ABMD, Accuray Incorporated ARAY and AngioDynamics, Inc. ANGO.

Abiomed is engaged in developing, manufacturing and marketing of medical products, designed to assist or replace the pumping function of the failing heart. The company’s main product line — Impella — comprises Impella 2.5, Impella 5.0, Impella LD, Impella CP and Impella RP.

Accuray designs, develops, and sells radiosurgery and radiation therapy systems for treatment of tumors in the body. The company’s product suite includes the CyberKnife Systems and the TomoTherapy Systems.

AngioDynamics designs, manufactures and sells a wide range of medical, surgical and diagnostic devices. The company’s offerings fall within three product line-ups — Peripheral Vascular, Vascular Access and Oncology/Surgery.

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