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2021
Vela Diagnostics expands automation options for SARS-CoV-2 RT-PCR Test
Fairfield, New Jersey, November 19, 2021 – Vela Diagnostics announced today that the ViroKey® SARS-CoV-2 RT-PCR Test v2.0 that received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), can now be used with the KingFisher FLEX system and Hamilton Microlab STAR platforms.
The same ViroKey® SARS-CoV-2 RT-PCR Test v2.0 kit now runs with the KingFisher FLEX, to decrease turnaround time and increase sample throughput. The workflow also maintains VELA’s proprietary SA201 Reporter as part of its workflow, providing pathologists an accurate and clinically relevant report.
Vela Diagnostics is now also offering a Hamilton Microlab STAR option, that has a throughput of 376 samples per run. PCR continues to be performed on the Sentosa SA201, and together with the SA201 Reporter delivers fast and accurate reporting.
Workflow test data for both options has been submitted to FDA and acknowledged as a supplement to the ViroKey® SARS-CoV-2 RT-PCR Test v2.0 EUA. While the modified test data has not been reviewed by FDA and product changes are in queue for review, commercial availability for the US market is provided through FDA’s EUA distribution policies.
“The Hamilton Microlab STAR workflow option comes at a time when many of our customers are still ramping up COVID-19 testing. This high-throughput workflow will allow laboratories to process substantially more samples per day, with less hands-on time and reduced labor cost,” said Steven Wallace, Executive Vice President.
“Our assay workflows have also been tested against, and are able to reliably detect, the Alpha, Beta, Gamma, and Delta variants. This reduces the risk of false negatives that some tests may have,” said Sam Dajani, CEO and Executive Chairman of the Board.
Vela Diagnostics’ new workflows complement its existing sample-to-result solutions, like the NGS workflow used for Sentosa SQ® HIV-1 Genotyping Assay (IVD) on the Sentosa SQ301, and OncoKey® SL 60 Plus that is compatible with the MiSeq, NextSeq and NovaSeq. Workflows include automation to replace essential hands-on steps like extraction, PCR setup, library preparation, result analysis and report generation. This reduces technician time, human errors, decreases risk of cross-contamination and improves traceability. Data analysis can be complicated and require skilled bioinformaticians, but VELA’s built-in analysis and interpretation software negates the need for that and produces accurate, clinically relevant reports.
About Vela Diagnostics
Vela Diagnostics is a leading provider for IVD solutions, from sample to result on an integrated workflow. VELA’s test solutions have the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa® products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
Vela Diagnostics announces collaboration with the National Cancer Centre of Singapore to refine novel cancer therapy
Singapore, Jun 4 2021 – Vela Diagnostics announced a collaboration with the National Cancer Centre of Singapore (NCCS) to develop a molecular diagnostic assay to predict individual patients’ responses to a cancer therapy called Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitors (TKIs). Being able to predict an individual’s response will help clinicians determine if EGFR-TKIs are a suitable therapeutic option for the patient. The partnership between Vela Diagnostics and NCCS aims to refine the therapeutic management of cancer to improve clinical outcomes.
EGFR is an oncogene with potential to cause cancer. Non-small cell lung cancer (NSCLC) has specific mutations in EGFR which makes them susceptible to treatment with EGFR-TKIs. However, these mutations are uncommon in other cancers so there are no established biomarkers for predicting a patient’s response to these drugs in cancers arising in the head, neck and oesophagus.
A study published in Nature Medicine in 2017, led by NCCS’ Professor Gopal Iyer and Associate Professor Daniel Tan, reported how a silent single-nucleotide polymorphism (SNP) in EGFR confers sensitivity to EGFR-TKIs in patients with head and neck cancers. The discovery has provided new avenues to identify previously unknown biomarkers of existing targeted therapies, with considerable potential for immediate repurposing and clinical impact.
In explaining the collaboration, Dr Charlie Lee, Head of Research and Development at Vela Diagnostics, said,“VELA is committed to developing diagnostics that aid therapy selection. With our proven expertise in assay development and track record in regulatory approvals, we are able to develop screening assays or companion diagnostics. Furthermore, this collaboration between two Singapore parties is beneficial as it will be relevant to cancer patients in Singapore and the region.”
“The collaboration between NCCS and Vela Diagnostics is unique because it allows both parties to contribute in the areas that they excel. The research that directed the assay development was conducted at NCCS, the assay is now being developed by Vela Diagnostics and the validation of the assay will be done at NCCS, where we have the infrastructure and experience to conduct robust clinical trials. We hope this will help clinicians advise their patients on the best treatment option for their cancers,” said Prof Gopal Iyer, Head of the Division of Medical Sciences, NCCS and Senior Consultant with the SingHealth Duke-NUS Head and Neck Centre.
The next phase of the collaboration will evaluate the efficacy of the assay through a clinical trial to test the response of patients to EGFR-TKIs. These will include patients with head and neck cancers based on the original discovery, and also other similar types of cancers arising from the lung, oesophagus, bladder and cervix. This trial will be led by Assoc Prof Daniel Tan, Deputy Head of the Division of Clinical Trials and Epidemiological Services and Senior Consultant in the Division of Medical Oncology, NCCS, supported by the Singapore Ministry of Health’s National Medical Research Council (NMRC) under its Clinician-Scientist Individual Research Grant (NMRC/CIRG/1492/2018) and the Singapore Translational Cancer Consortium.
About Vela Diagnostics
Vela Diagnostics is a leading provider for IVD solutions, from sample to result on an integrated workflow. VELA’s test solutions has the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
For more information, visit www.veladx.com.
About the National Cancer Centre of Singapore
The National Cancer Centre of Singapore (NCCS) provides a holistic and multi-disciplinary approach to cancer treatment and patient care. We see close to 65 per cent of the public sector oncology cases, and they are benefiting from the sub-specialisation of our clinical oncologists.
To deliver among the best in cancer treatment and care, our clinicians work closely with our scientists who conduct robust, cutting-edge clinical and translational research programmes which are internationally recognised. NCCS strives to be a global leading cancer centre, and shares its expertise and knowledge by offering training to local and overseas medical professionals.
For more information, please visit: www.nccs.com.sg
Vela Diagnostics receives CE-IVD approval for automated Flu A/B & RSV Extension Kit
Singapore, Mar 17 2020 – Vela Diagnostics announced today that its ViroKey™ Flu A/B & RSV RT-PCR Extension Kit (for use only with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0), has received the CE mark for in vitro diagnostic use.
The ViroKey™ Flu A/B & RSV RT-PCR Extension Kit detects Influenza A, Influenza B and RSV by targeting the matrix protein gene in the RNA of the respective viruses. The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 RNA—the ORF1a and N genes.
The tests are optimized on a workflow consisting of the Sentosa™ SX101 instrument for automated sample extraction and PCR setup, in conjunction with the Sentosa™ SA201 instrument. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 46 samples (and two controls) can be tested—to detect up to four viruses—in a single run. The PCR is set up as two separate reactions; one to detect SARS-CoV-2, and the other for the Flu A/B and RSV triplex. This prevents masking of low positive results, resulting in higher sensitivity of detection.
“The flu season and the recent appearance of a new SARS-CoV-2 variant makes pandemic management all the more challenging, especially when these viral infections cause similar symptoms in patients. With the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit, we can distinguish across the four viruses in patients with flu-like symptoms, thus enabling clinicians to prescribe the appropriate treatment protocol at the soonest,” said Managing Director, Andreas Goertz.
The ViroKeyTM SARS-CoV-2 RT-PCR Test v2.0 received the CE mark in July 2020.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
Vela Diagnostics adds two SARS-CoV-2 assays for virus genotyping, and variant identification to its COVID-19 testing solutions
Singapore, February 26 2021 – Vela Diagnostics announced that it has added ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay and ViroKey™ SARS-CoV-2 ID RT-PCR Test to its portfolio offering.
The ViroKey™ SQ FLEX SARS-CoV-2 Genotyping Assay (RUO) harnesses next-generation sequencing (NGS) technology to sequence the whole SARS-CoV-2 genome. The accompanying Sentosa™ SQ Reporter software calls out mutations and classifies them by lineage, thereby aiding in the research and understanding of the molecular epidemiology of the COVID-19 pandemic. According to WHO, whole-genome sequencing is essential for improving effectiveness/sensitivity of molecular diagnostics, serological assays, vaccine design and anti-viral therapy, and aiding investigation of transmission routes and outbreak clusters.
“We offer a highly automated workflow which requires less than 2 hours of hands-on time from sample to report generation. With this ease-of-use, laboratories can very quickly adopt an NGS solution that would become an important tool in this pandemic situation,” said Managing Director, Andreas Goertz.
The ViroKey™ SARS-CoV-2 ID RT-PCR Test (RUO) is able to quickly identify variants present in positive samples. Variants include the B.1.1.7 (UK), B.1.351 (South Africa) and P.1 (Brazil) lineages.
“Identification of variants that may cause more severe disease or be more contagious is critical in our global response to the pandemic. Such variants may lead to more cases of COVID-19, putting a strain on healthcare systems and potentially leading to more deaths. As such, they need to be identified promptly for measures to be taken,” says Vice President, Jim Mismas.
“With emerging variants, like the recent B.1.526 from New York, that may weaken vaccine effectiveness, the need for mutation identification becomes clear. We are now able to offer options for quick detection of known variants of concerns, and all future variants for better pandemic management,” says Director of Business Development, Scott Cassidy.
The variant identification test can be used in conjunction with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0, which has received FDA Emergency Use Authorization, CE-IVD and TGA approval, and HSA Provisional Authorization.
About Vela Diagnostics
Vela Diagnostics is a leading provider for integrated IVD system solutions, from sample to result. VELA’s test solutions utilize the automated Sentosa™ platform, providing the unique ability to leverage one system for NGS and PCR testing in infectious disease and oncology.
All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.
RUO: For research use only. Not for use in diagnostic procedures.