Press Releases

Vela Diagnostics Launches Multiplex PCR-Based Test for Detecting UTI Pathogens and Antimicrobial Resistance Genes

Fairfield, New Jersey, 17 May, 2022 – Vela Diagnostics announced today the launch of its new PathoKey® MP UTI ID and AMR PCR Test for research use only (RUO*).

This multiplex PCR-based test allows for the in vitro detection and differentiation of 14 pathogens that cause urinary tract infections (UTI), as well as 14 antimicrobial resistance (AMR) genes encoding resistance to 5 antibiotics, all in one run. The test is compatible with common real-time PCR cyclers, such as the Rotor-Gene Q 5/6 plex Platforms and QuantStudio 5 Real-Time PCR System.

Notably, Vela Diagnostics’ proprietary Sentosa® SA201 Reporter can generate a report that consolidates pathogen and AMR results for each sample when used with the Sentosa SA201 or Applied Biosystems 7500 Fast Dx, providing users with access to a comprehensive yet easy-to-read report.

The test offers laboratories the option of using either an automated or manual workflow. Laboratories with high throughput can choose from two of Vela Diagnostics’ highly-automated solutions, which incorporate the Sentosa SX101 instrument for extraction and PCR setup, generating a report within 4 hours, and with as little as 30 minutes of hands-on time. The second automated workflow includes the KingFisher Flex instrument for an even higher throughput.

Laboratories with lower throughput may choose to employ the manual workflow option to prevent wastage as batching is not required.

“When designing our PathoKey MP UTI ID and AMR PCR Test, we prioritized automation, flexibility and comprehensive report generation,” said Dr Charlie Lee, Head of Research and Development of Vela Diagnostics. “We believe that through comprehensive data analysis and reporting, VELA’s UTI solution will give timely and insightful results to customers. Being a 2-in-1 test, it is able to detect and differentiate between the UTI-inducing pathogens as well as their AMR profiles in one run, improving lab efficiency.”

Scott Cassidy, Director of Business Development, is optimistic about the adoption of VELA’s PathoKey UTI Tests. “Following the COVID-19 pandemic, our install base has widened substantially. We plan to leverage the channels we have established throughout this period to firmly plant our foot in the UTI diagnostics market,” said Mr Cassidy. “We will look into creating a version of the test compatible with the Hamilton instrument, allowing for higher throughput according to market demand.”

“Laboratories wishing to gain further insights into their samples will have the reflex option of using our PathoKey SQ FLEX Pathogen ID Assay, which will be launched in the third quarter of 2022,” said Sam Dajani, Chairman and CEO of Vela Diagnostics. “The NGS-based assay enables users to delve into the microbial makeup of their samples, including the identification of pathogens which may be missed by PCR-based tests.”

*Performance characteristics have not yet been established.

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. All other product names, trademarks and logos are the property of their respective owners.

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Media Pooling Strategy to Increase Testing Throughput Added to Vela Diagnostics’ ViroKey SARS-CoV-2 RT-PCR Test v2.0

Fairfield, New Jersey, April 22, 2022 – Vela Diagnostics has announced that its ViroKey® SARS-CoV-2 RT-PCR Test v2.0 now has the additional capability to be used for pooling, using a three-in-one media pooling strategy.

This FDA EUA authorized indication is authorized for use in laboratories certified under CLIA to perform high complexity tests, for the qualitative detection of RNA from the SARS-CoV-2 in pooled samples containing aliquots of transport media from up to 3 individual human anterior nasal swab specimens from not only individuals who are symptomatic, but also those who are asymptomatic and are participation in serial testing programs.

The ViroKey SARS-CoV-2 RT-PCR Test v2.0 was developed by Vela Diagnostics for the detection of SARS-CoV-2, the virus behind the global pandemic of COVID-19. With at least three workflows available, laboratories can leverage that flexibility, depending on what the throughput of their laboratory is.

This pooling strategy can be done by combining sample media of up to 3 patients to be tested as one sample, thereby only using resources needed for a single test. In a population with low positivity rate, this method increases testing throughput, improves laboratory efficiency, and reduces overall cost of testing.

“At Vela Diagnostics, we aim to provide solutions that work in real situations. With the FDA encouraging the development of tests for pooled samples, we have added the ability to aid in the increase of testing throughput,” said Sam Dajani, Chairman and CEO of Vela Diagnostics.

“Laboratories can now leverage this capability to cope with the sudden surges that we have all experienced in waves throughout this pandemic,” said Scott Cassidy, Director of Business Development. “We believe this is an important capability in the COVID-19 pandemic, where incidences and levels of testing can fluctuate at any time.”

The ViroKey SARS-CoV-2 RT-PCR Test v2.0 received its EUA in September 2020, has CE mark in EU, and is also approved by Australian TGA and multiple regulatory authorities globally.

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.

For more information, visit www.veladx.com.

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Vela Diagnostics Launches Focused (60 Genes) and Comprehensive (525 Genes) NGS-Based Pan-Cancer Panels

Hamburg, Germany, March 28, 2022 – Vela Diagnostics announced today the launch of its new OncoKey® SL 60 and 525 Plus Panels. These next-generation sequencing (NGS)-based panels are intended for detection of DNA and RNA cancer biomarkers from formalin-fixed paraffin-embedded (FFPE) tissue specimens, for up to 64 samples in a single sequencing run.

Vela Diagnostics offers two pan-cancer gene panels: the focused OncoKey® SL 60 Plus Panel, and the comprehensive OncoKey® SL 525 Plus Panel. With just 40 ng of nucleic acid, the panel can detect the following biomarkers in one assay: single nucleotide variations (SNVs), insertions/deletions (INDELs), copy number variations (CNVs), microsatellite instability (MSI), fusions, splice variants, oncogenic viruses and bacteria, as well as measuring the tumor mutation burden (TMB).

These NGS-based panels feature a highly-automated, sample-to-result workflow. They are able to produce results within 5 days, requiring only 2.5 hours of hands-on time, and provide high sample traceability, from automated sample extraction to data quality control (QC). VELA® Analytics can create concise, evidence-based in-house reports that help customers with the information to make timely, informed decisions about possible treatment options. Additionally, laboratories with low sample volumes can choose to perform the assays in a manual workflow.

Crucially, the OncoKey® SL 60 and 525 Plus Panel workflow is wrapped around Illumina sequencing platforms. Thus, the panels can be seamlessly adapted to current lab situations. Combined with dual UMI-UDI adapters, hybrid capture target enrichment, sequencing by synthesis and thoroughly validated bioinformatics pipeline, the panels boast high sensitivity and comprehensive variant profiling, plus sequencing coverage uniformity.

“VELA’s OncoKey® 60 and 525 Plus Panels represent an exciting development in precision medicine for cancer,” said Dr Andreas Goertz, Managing Director of Vela Diagnostics’ European organization. “These panels consist of clinically relevant genes of interest and were designed based on input from key opinion leaders in oncology, as well as references to professional guidelines, curated clinical trial and cancer databases.”

“Vela Diagnostics is planning to launch our OncoKey® 60 and 525 Plus Panels in Q4 2022 in the USA and Asia Pacific,” said Sam Dajani, CEO and Executive Chairman of Vela Diagnostics. “Using these panels on Vela Diagnostics’ automated workflow will reduce human error and minimize sample cross contamination which can be generated by using a manual workflow. In addition, our VELA® Analytics solutions and services can identify and interpret genetic variants in tumors making it possible to provide actionable options for healthcare and research professionals quickly and accurately,” added Mr Dajani.

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, visitwww.veladx.com. All other product names, trademarks and logos are the property of their respective owners.

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Healthcare providers can expect to receive US$725 reimbursement from CMS when using NGS-based Sentosa® SQ HIV-1 Genotyping Assay

Fairfield, New Jersey, January 07, 2022 – Vela Diagnostics announced that its Sentosa® SQ HIV-1 Genotyping Assay is covered for reimbursement from The Centers for Medicare and Medicaid (CMS) starting January 2022.

Based on the 2022 Clinical Diagnostic Laboratory Fee Schedule by CMS, healthcare providers using the Sentosa® SQ HIV-1 Genotyping Assay solution with the assigned descriptor for therapeutic diagnoses can expect a reimbursement of US$725 using CPT code 0219U for HIV gene analysis*.

The Sentosa® SQ HIV-1 Genotyping Assay is a sample-to-result solution that uses Next-Generation Sequencing (NGS) on the Sentosa® NGS Workflow, offering automation for extraction, library and template preparation, and bioinformatics analysis with reference to the Stanford University HIV Drug Resistance Database. The assay analyses three key drug targets (Protease, Reverse Transcriptase and Integrase) within a virus’s genome, in a single run. Mutations in these regions can confer drug resistance and lead to treatment failure. Analysis of the Integrase gene is notable – this Sentosa® assay is currently the only FDA-authorized genotyping assay with this capability.

Automation could be the key to streamlining genotyping in clinical settings, which is historically an arduous and time-consuming process. “Our Sentosa®SQ HIV-1 Genotyping Assay drastically reduces technician time compared to traditional methods based on Sanger sequencing, requiring less than 2 hours of hands-on time from sample to report generation. By combining efficiency of NGS techniques and testing three common drug targets in one run, our solution provides critical insights into the virus’s drug resistance profile in an efficient and simplified workflow,” said Steve Wallace, Executive Vice President.

“There are around 1.1 million people in the US living with HIV, and 25.4 million in the WHO African Region, of which roughly 8 million people with HIV are undiagnosed or poorly treated. In the current COVID-19 pandemic, this HIV-positive population could serve as a large reservoir for the emergence of SARS-CoV-2 variants, like the recent Omicron, that possibly could have been incubated in a person who was immunocompromised,” said Sam Dajani, CEO and Executive Chairman of the Board.

“We are the encouraged that CMS now reimburses our Sentosa® SQ HIV-1 Genotyping Assay. This will allow more laboratories to bridge the gap that may have been deterring them from moving onto a newer technology that gives higher sensitivity and possibly better clinical outcomes to HIV patients,” added Mr Dajani.

In addition to receiving the FDA De Novo authorization, the assay has received approval from Thailand FDA and Singapore HSA.

*As applicable, per CMS reimbursement rules.

 

About Vela Diagnostics

Vela Diagnostics is a leading provider for IVD solutions, from sample to result on an integrated workflow. VELA’s testing 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.

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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.

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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

 

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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 SentosaSX101 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.

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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.

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Vela Diagnostics Launches Test Kits to Differentiate Between Flu, RSV and SARS-CoV-2

Singapore, October 5 2020– Vela Diagnostics announced today the release of the ViroKey™ Flu A/B & RSV RT-PCR Extension Kit for research use (RUO). This extension kit is intended for use with Vela Diagnostics’ automated PCR workflow with the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 which tests for the SARS-CoV-2 virus.

The concurrent use of ViroKey™ Flu A/B & RSV RT-PCR Extension Kit with ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 allows the differentiation of four virus types – Influenza A, Influenza B, Respiratory Syncytial Virus (RSV) and SARS-CoV-2 – in nasopharyngeal and oropharyngeal swabs.

The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has garnered Emergency Use Authorization (EUA) from the U.S. FDA, CE-IVD and Australian Therapeutic Goods Administration (TGA) approvals, as well as Provisional Authorisation from the Health Sciences Authority in Singapore.

The automated workflow comprises of the Sentosa™ SX101 instrument and the Sentosa™ SA201 RT-PCR instrument, or the ABI 7500 Fast Dx. This workflow enables minimal hands-on time and tests for up to 46 samples and two controls per run with a turnaround time expected at 4.5 hours.

“The release of our Flu and RSV extension test kit is timely. It is a challenge to differentiate between Flu, RSV and SARS-CoV-2 simply based on symptoms alone, and with the flu season expected in the coming month, this solution will aid in the research of those respiratory viruses,” said Sam Dajani, CEO and Chairman of the Board. 

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.

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Vela Diagnostics’ SARS-CoV-2 RT-PCR Test v2.0 Authorized for Emergency Use in the U.S.

Fairfield, New Jersey, September 22 2020 – Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has obtained the Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). This automated probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus responsible for COVID-19, in nasopharyngeal and oropharyngeal swabs. With the EUA, laboratories in the United States certified under the Clinical Laboratory Improvement Amendments will now be able to use the test for COVID-19 detection.

“Receiving the EUA for our automated COVID-19 detection kit will enable us to better assist laboratory and healthcare personnel in managing the pandemic in the U.S.,” said Sam Dajani, CEO and Chairman of the Board.  

The ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 is an automated probe-based reverse transcription PCR test optimized for a workflow consisting of Vela Diagnostics’ Sentosa® SX101 and the Sentosa® SA201 instrument (or ABI 7500 Fast Dx). The automated test enables high throughput testing of up to 46 samples in a single run, with reduced hands-on time.

Besides receiving EUA from the FDA, the ViroKey™ SARS-CoV-2 RT-PCR Test v2.0 has also received the CE mark and Provisional Authorisation from the Singapore Health Sciences Authority.

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.

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