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2022

Vela Diagnostics Develops PCR-based Test for Detecting Monkeypox Virus

Singapore, July 26, 2022 – Vela Diagnostics announced that it has developed a PCR test kit to detect the monkeypox virus (MPXV), for research use only (RUO).

The ViroKey® MPXV PCR Test allows for the prompt, in vitro detection of MPXV DNA from human skin lesion specimens. It is compatible with common real-time PCR cyclers, such as the Rotor-Gene Q and Applied Biosystems 7500 series platforms. In silico testing shows that the assay is specific for MPXV and has no cross-reactivity with other orthopoxviruses.

“We worked closely with our customers to develop a test that is specifically designed to meet their requirements, making sure that they have a monkeypox-specific assay, with maximum flexibility to choose between manual and automated workflows depending on the number of samples they receive,” said Dr Charlie Lee, Head of Research and Development at Vela Diagnostics. 

The monkeypox outbreak has been declared a global health emergency by the World Health Organization (WHO), with over 16,000 cases worldwide. The mode of transmission is thought to be close, sustained physical contact with other people who have monkeypox. The WHO has requested for all countries to provide testing for any individuals that meet the suspected case definition, and to immediately notify it in the case of positive laboratory results.

“Throughout the COVID-19 pandemic, we have worked closely with various testing labs across the globe. We responded quickly to the monkeypox epidemic by allowing research partners and laboratories to offer timely and accurate monkeypox testing,” said Sam Dajani, CEO of Vela Diagnostics and Chairman of the Board. “We have already released the first few batches of kits, and they are being evaluated by our customers globally. We are committed to increasing testing capacity of monkeypox in hopes of containing the spread of the virus.”

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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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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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