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Luminex Corporation's VERIGENE Gram-Positive and Gram-Negative Blood Culture Panels Receive Reimbursement Approval in Japan

2017-06-12 18:34
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-Molecular Assays Shorten Times to Results and Improve Management of Infectious Diseases

AUSTIN, Texas, June 12, 2017 /PRNewswire/ -- Luminex Corporation (NASDAQ: LMNX)  recently announced that Japan's Central Social Insurance Medical Council has approved the recommendation by the Japanese Ministry of Health, Labor and Welfare (MHLW) to provide reimbursement for two VERIGENE® assays: the Gram-Positive Blood Culture (BC-GP) test and the Gram-Negative Blood Culture (BC-GN) test.

The MHLW established reimbursement went into effect on June 1, 2017. This decision follows regulatory clearance of these panels by Japan's Pharmaceuticals & Medical Devices Agency in 2016.

The VERIGENE System enables clinicians to rapidly identify the pathogens responsible for some of the most complex, costly, and deadly infectious diseases, without relying on time-consuming culture methods. The first sample to answer system cleared for molecular diagnosis of bloodstream infections, VERIGENE provides cost-effective bacterial identification and antibiotic resistance determination directly from positive blood culture bottles up to 48 hours faster than conventional methods.

"This decision opens the market for VERIGENE placements in Japan, the second largest market for molecular diagnostics," said Homi Shamir, President and Chief Executive Officer of Luminex. "With our partner, Hitachi High-Technologies (Hitachi High-Tech), we will initially target the large and mid-size hospitals with molecular diagnostics facilities in Japan. We believe all can benefit from the ability to more quickly and cost-effectively differentiate potential blood culture contaminants to improve patient outcomes with the most effective antibiotic treatment. This should assist in saving patient lives while lowering costs and reducing the spread of antibiotic resistance."

"We intend to register additional VERIGENE products in Japan, and looking forward to working with Hitachi High-Tech to support our customers in Japan," Mr. Shamir added.

About Sepsis

Sepsis is a life-threatening response to bacteria in the bloodstream. It is responsible for 1.6 million hospitalizations and nearly 200,000 deaths per year in the United States.1,2 It costs the U.S. healthcare system more than $20 billion per year3 and is commonly complicated by antimicrobial resistance. Earlier diagnosis of sepsis leads to better outcomes, as the risk of death increases by 7.6% every hour that appropriate treatment is delayed. Targeted therapy based on identification of causative bacteria and antibacterial resistance is the most effective sepsis treatment.4

1  Healthcare Cost and Utilization Project. Statistical Brief #122. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb122.pdf. Accessed December 22, 2013.

2  Angus, D.C., Linde-Zwirble, W.T., Lidicker, J., Clermont, G., Carcillo, J., Pinsky, M.R. Epidemiology of severe sepsis in the United States: analysis of incidence, outcome, and associated costs of care. Crit Care Med. 2001 Jul;29(7):1303-10.

3  Healthcare Cost and Utilization Project. Statistical Brief #160. http://www.hcup-us.ahrq.gov/reports/statbriefs/sb160.pdf. Accessed November 4, 2013.

4  Kumar A, et al. Duration of hypotension before initiation of effective antimicrobial therapy is the critical determinant of survival in human septic shock. Crit Care Med 2006, 34:1589-1596.

About Luminex Corporation

At Luminex, our mission is to empower labs to obtain reliable, timely, and actionable answers, ultimately advancing health.  We offer a wide range of solutions applicable in diverse markets including clinical diagnostics, pharmaceutical drug discovery, biomedical research, genomic and proteomic research, biodefense research, and food safety. We accelerate reliable answers while simplifying complexity and deliver certainty with a seamless experience. To learn more about Luminex, please visit us at www.luminexcorp.com.

Contacts:

Luminex Investor Contact
Harriss Currie, +1.512.219.8020
Sr. Vice President of Finance and CFO
hcurrie@luminexcorp.com

Luminex Global Media Contact
Christine Valle, +1.512.219.8020
Sr. Manager, Global Marketing Communications
cvalle@luminexcorp.com

Luminex Japan Media Contact
Yumiko Hasegawa, +81.03.5545.7445
Manager, Marketing Communications, Asia Pacific
yhasegawa@luminexcorp.com

Source: Luminex Corporation

Related stocks: NASDAQ-NMS:LMNX

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