AdvancedDx Biological Laboratories USA Commits to Bringing One Million COVID-19 Tests to the US Market Over the Next 90 Days
Company Submits EUA Application to FDA to Commercialize First COVID-19 Test in Communities in the U.S.
NEWBURYPORT, Mass., May 7, 2020 /PRNewswire/ -- AdvancedDx Biological Laboratories USA, Inc. (ABLDx), a virologic diagnostic solutions company, announced today that it intends to bring one million molecular, serological and genotypical COVID-19 tests to the U.S. market over the next 90 days. As part of the FDA'S Emergency Use Authorization (EUA) program, ABLDx has received confirmation from the FDA of the EUA application. The company will distribute for clinical use, its validated UltraGene® Combo2Screen SARS-CoV-2 assay.
"Massive COVID-19 diagnostic testing is what is needed across the U.S. and why we are committed to delivering one million tests to communities like Boston and Miami, with the high degree of accuracy the market is now demanding," explained Dr. Anthony J. Japour, Chief Executive Officer of ABLDx. "Our molecular diagnostic test to improve detection is the first step in an ongoing commitment to combat COVID-19, with a portfolio of solutions that include tests to identify the presence of antibodies."
Advanced Biological Laboratories S.A., the parent company of ABLDx, based in the EU is a company with a 10-year track record in virology and infectious disease testing. The UltraGene® Combo2Screen SARS-CoV-2 assay can be used for the qualitative detection of nucleic acids from severe acute respiratory syndrome-associated with coronavirus 2 (SARS-CoV-2), or as it is more commonly referred to, the COVID-19 infection. In Europe, the test has received CE IVD certification.
The UltraGene® Combo2Screen SARS-CoV-2 assay achieved 100 percent clinical reproducibility, in proving its performance and accuracy. As part of the 2020 Coronavirus Outbreak Preparedness (CVOP) study from Quality Control for Molecular Diagnostics (QCMD), an independent quality assessment and proficiency testing organization, the assay performed to expectation in all eight tests.
Targeting two genes instead one gene, the conserved regions of the SARS-CoV-2 genome (N gene + E Gene) are probed. The UltraGene® Combo2Screen SARS-CoV-2 assay is a very sensitive and versatile methodology in detecting the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples that a healthcare provider collects from the back of a patient's throat or nose. ABLDx's product line will include swab collection kits which have been in short supply within the USA.
As an added advantage to laboratories, the UltraGene® Combo2Screen SARS-CoV-2 assay is compatible with most automatic or manual RNA extraction, eliminating concerns about finding a testing solution that will work on their systems.
Dr. Chalom Sayada, Chairman of Advanced Biological Laboratories, S.A., added, "As global citizens, we are compelled to join the fight in stopping the spread of COVID-19 disease. Our UltraGene® Combo2Screen assay is designed to help additional virology labs perform SARS- CoV-2 detection and improve overall management of patients suffering from the disease. We look forward to bringing tests to the U.S. and being part of the solution that helps communities recover from this global pandemic."
"Our goal is to strengthen the management and containment of COVID-19," said Dr. Japour. "As leading scientists have taught us through generations, 'To measure is to know.'"
About AdvancedDx Biological Laboratories (ABLDx)
AdvancedDx Biological Laboratories, USA Inc. (ABLDx) (www.abldx.com) is a wholly-owned subsidiary of ABL Group, with headquarters in Luxembourg, Advanced Biological Laboratories (ABL), S.A., and is headquartered in Newburyport, MA. It was formed in 2019 to commercialize viral diagnostic solutions and its current focus is on the COVID-19 global pandemic and the need for testing in local communities across the U.S.
About Advanced Biological Laboratories (ABL SA)
Advanced Biological Laboratories (ABL), S.A., (www.ablsa.com) is a Diagnostic and Medical Software company founded in 2000 as a spin-off from CRP-Santé and LIH Luxembourg. ABL's products offer to infectious disease clinicians, virology and microbiology laboratories:
- Assays and standalone software systems for accredited laboratories (i.e. ISO 15189), mainly for microbiology applications (related to HIV, Coronavirus, Tuberculosis, HCV, HBV, HPV, CMV, HPV, Flu, 16s RNA) for clinical genotyping through sequencing (DeepChek®), DNA and RNA detection and quantification (UltraGene™), including powerful downstream analysis software applications fully integrated with knowledge databases and analysis systems for capillary and high-throughput Next Generation Sequencing data.
- Clinical software applications for infectious diseases units
- IT dashboards and clinical database aggregation applications for research and clinical management
ABL has a comprehensive suite of healthcare management products, including Nadis®, TherapyEdge®, ViroScore®, SeqHepB, DeepChek®, UltraGene®, VisibleChek®, HepatiC®, BacterioChek, MicrobioChek and the DPM used for data and patient management, monitoring and personalized reporting applications. In 2012, some of ABL's products also received CE-marking for IVD use. In 2020 ABL got CE IVD for its DeepChek®-HIV assays as well as for its UltraGene-SARS-CoV-2 assay. The other products are currently available for Research Use Only.
SOURCE AdvancedDx Biological Laboratories
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