This validation of batch testing using the industry's most sensitive assay to date according to the FDA Reference Panel leverages its proven ability to detect low amounts of viral genetic material.
Laboratories certified under the Clinical Laboratory Improvement Amendments can now use PerkinElmer's real-time RT-PCR in vitro diagnostic assay for COVID-19 to pool multiple samples together using the resources needed for a single test.
If a pooled test is negative, all the individual samples are considered negative.
If the pooled test is positive, each of the individual samples in that pool should be tested again separately to determine which of the samples are positive. For sample pooling to be effective, screening using a highly sensitive test is integral.
From comparative data released by the FDA, the PerkinElmer New Coronavirus Nucleic Acid Detection Kit has the lowest Limit of Detection among the authorized COVID-19 molecular diagnostic tests reported, deeming it the most sensitive assay that can detect 3-fold less viral material in samples compared to the assay in second place, and over 90-fold times less viral material in samples compared to the industry average.
PerkinElmer has been on the front lines of improving COVID-19 test turnaround times enabled by increasing production capacity of viral RNA extraction, RT-PCR tests and live streaming availability status to meet evolving public health needs.
PerkinElmer is actively working with specialty and reference diagnostic labs, clinics, hospitals, pharmaceutical and biopharmaceutical labs, academia, and governmental and research institutes to battle the pandemic.
PerkinElmer's SARS-CoV-2 offerings span high throughput RNA extraction, RT-PCR, automation, ELISA, chemiluminescence, time-resolved fluorescence and lateral flow based serology testing.
PerkinElmer offers solutions to serve the diagnostics, life sciences, food, and applied markets.
PureTech completes enrollment in Phase 2b ELEVATE IPF trial for LYT-100
Cybin secures additional US patent for CYB003 breakthrough therapy programme
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
Biophytis reinforces obesity IP with new patent application
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Fusion Antibodies plc secures contract for OptiPhage library development
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
AbbVie announces interim evaluation of Atogepant Phase three, open-label 156-week extension study
Precision Epigenomics partners with TruDiagnostic
Modalis partners with Ginkgo Bioworks
Stamford Pharmaceuticals starts locally advanced basal cell carcinoma (laBCC) trial of SP-002
Algiax Pharmaceuticals reveals update on chronic neuropathic pain study