Seegene’s Allplex™ RV Master Assay receives Australian TGA approval, European CE mark
Test detects 21 targets for 19 respiratory viruses
in single tube, including COVID-19 and fluAssay result of Seegene’s decades-long know-how,
applies DPO∙TOCE∙MuDT technologies
“Optimal solution for safe return to normalcy as
distancing restrictions eased”South
Korea’s leading molecular diagnostics (MDx) company, today announced that its
Allplex™
RV Master Assay has received approval from Australia’s Therapeutic Goods Administration and achieved the European
CE-IVD marking. Therapeutic goods must be entered in the Australian Register of Therapeutic Goods
before they can be supplied in the country. The CE-IVD marking
is a legal requirement for marketing medical devices in the European Union. Seegene’s
Allplex™
RV Master Assay can distinguish 21 targets for 19 different
respiratory viruses, including COVID-19, flu, and common colds. Specifically,
the assay can identify three genes of COVID-19, Flu A, Flu B, metapneumovirus, two types of respiratory syncytial virus,
four types of parainfluenza virus, six types of adenovirus and three types of human
rhinovirus (see table 1). The
Allplex™
RV Master Assay was developed based on Seegene’s
decades-long know-how and applies patent technologies, like DPO™,
TOCE™ and MuDT™
(see table 2). The syndromic test allows medical specialists to swiftly find
out which viruses are making the patient sick with a single sample. The
world has turned its focus to living with COVID-19 endemically and relaxed
social distancing and mask restrictions have created an environment for various
respiratory viruses to circulate with ease. Recent
data from FluTracking, a surveillance system used to detect
influenza in Australia, found 10-15% of respondents with fever and cough
symptoms in some cities, as the southern hemisphere heads into the winter
season. Seegene’s
independent clinical test recently conducted in
Europe using the Allplex™ RV Master Assay on 1,928
people also found that 16.5% (318 people) tested positive for respiratory
viruses, excluding COVID-19. Of that figure, 6.9% (22 people) had contracted
two or more viruses. Symptoms
of COVID-19, such as coughing and fever, can also be a sign of other
respiratory infections. This make testing critical
for proper care as treatments can vary by infection type and to reduce the
potential of co-infection. A study published in The Lancet shows that patients that contracted both COVID-19 and flu
had more than double the risk of death, while the need for invasive medical
ventilation jumped by four-fold. The Allplex™ RV Master
Assay has been designed in consideration of such circumstances as countries
shift policies to get everyday life back to normal. “Allplex™ RV Master Assay can
detect respiratory viruses that can occur all-year round to simplify the
diagnostic of the ‘new normal’ respiratory virus composition,” said Dr. Tove Havnhøj Frandsen of
Sygehus Sonderjylland (Hospital of Southern Jutland)/RenTov Consult, who led
Seegene’s clinical test in Europe. ”The assay
is expected to be well-utilized as winter approaches in Australia and South
America and as the world turns to live with COVID-19 endemically.”
Table 1. Allplex™ RV Master Assay
targets
VIRUS
VIRUS SUB-TYPE
COVID-19
(Target gene)
COVID-19
(S, N, RdRP gene)
Influenza A
Influenza A
Influenza B
Influenza B
Metapneumovirus (MPV)
MPV
Respiratory Syncytial Virus (RSV)
RSV A, RSV B
Parainfluenza virus (PIV)
PIV1, PIV2, PIV3, PIV4
Adenovirus (AdV)
AdV A, AdV B, AdV C, AdV D, AdV E, AdV F
Human Rhinovirus (HRV)
HRV A, HRV B, HRV C
Table 2. Seegene's patent
technologies
DPO™
(Dual Priming Oligonucleotide)
Multiple target amplification
technology that enhances target specificity and minimizes non-specific
amplification commonly occurred in multiplex PCR
TOCE™
(Tagging Oligonucleotide
Cleavage and Extension)
Oligonucleotide chemistry
solution for homogenous high multiplex real-time PCR. TOCE technology enables
detection and differentiation of multiple targets in single fluorescence channel
through melting temperature analysis
MuDT™
(Multiple Detection Temperatures)
Analytical real-time PCR
technology which enables detection of multiple targets with individual Ct
value in single channel without melting curve analysis
Apr 06, 2022Ver Detalles >
