Rockville (MD), August 2, 2017 —
Diseases caused by infection are among the hardest challenges for healthcare, and require early and accurate detection for treatment to be optimized. And according to IVD market researcher Kalorama Information, they are also among the largest and most competitive markets for IVD instruments, kits and reagents. Thus it is no surprise that at the laboratory industry’s largest meeting, the AACC, this week in San Diego, speed and effectiveness in infectious disease detection are among the important product announcements at the American Association for Clinical Chemistry Meeting (AACC 2017) in San Diego, California. The New York City-based healthcare research firm covers IVD in its Worldwide Market for In Vitro Diagnostics, 10th Edition
, a comprehensive in vitro diagnostics market research study.
Kalorama Information noted the following developments:
- Clinical Chemistry Magazine's AACC 2017 issue focused on the Myanmar H1N1 flu outbreak, worse since 2009, which has claimed 10 lives, and also a new method for detecting 5 gram-negative bacteria using genoproteomic peptide marker analysis on a combined MS/LC system.
- Ortho Clinical Diagnostics showcased the Vitros Immunodiagnostic Products human immunodeficiency virus (HIV) combo assay for use on the Vitros 3600 immunodiagnostic system. In February, the company announced it had submitted a premarket approval (PMA) application to FDA for the product. The company has also submitted PMA supplements for the Vitros HBeAg and Anti-HBe assays, for use on the Vitros 3600 immunodiagnostic system and Vitros 5600 integrated system. A fourth-generation HIV assay, the Vitros HIV combo is designed to detect acute HIV-1 infection earlier than previous generations of HIV assays. The assay was CE marked in 2016 and is currently available in Europe and other countries that accept the CE mark. Developed to diagnose hepatitis B, the Vitros HBeAg and Anti-HBe assays are currently approved for use on Ortho’s Vitros ECi/ECiQ immunodiagnostic system. Ortho submitted two PMA supplements for review to migrate these existing assays onto Ortho’s Vitros 5600 and Vitros 3600 systems.
- New YFV Protein: Aalto Bio Reagents announced their first-to-market recombinant Yellow Fever Virus (YFV) protein at AACC in San Diego from 1st - 3rd August. Yellow Fever virus is a potentially fatal mosquito-borne flavivirus which is prevalent in tropical and subtropical locations in South America and Africa. It is the next flavivirus threatening the population of Brazil, with local health officials reporting a sharp rise in cases this year. The company, founded in 1978, Aalto Bio Reagents is a developer and provider of raw materials to the in- vitro diagnostics industry and to research laboratories globally. Infectious disease is one of the most important markets for IVD, and Kalorama covers this extensively in its market study on this area.
- Same Day Multiplex For TB, Sepsis, Meningitis, Others: Seegene Inc. announced a Random Access System. The company says the system can provide order-to-report on the same day by simultaneously performing high multiplex real-time PCR testing on a single platform, regardless of specimen type or assays. Rapid, accurate diagnosis and prompt treatment are especially critical for a successful treatment of infectious diseases such as tuberculosis, acute diarrhea, sepsis or meningitis. The company said most existing MDx systems are unable to perform same-day reporting for same day treatment, because clinical laboratories typically perform testing after a sufficient number of specimens are collected.
- An AACC seminar conclude that rapid point of care testing has a real impact in curbing acute bacterial rhinosinusitis (ABR) in adults by testing for strep B.
Kalorama covers the IVD market in its report, Worldwide Market for In Vitro Diagnostics, 10th Edition
About Kalorama Information
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