Press Releases

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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Vela Diagnostics Launches NGS-Based, Pan-Cancer Assay that Detects SNVs, INDELS, CNVs, MSI, Fusions and Oncogenic Pathogens in more than 60 Genes

Singapore, August 31 2020 - Vela Diagnostics announced today the launch of the OncoKey™ SL 60 Plus Assay. The assay is a next-generation sequencing (NGS)-based, pan-cancer test that detects single nucleotide variations (SNVs), insertions/deletions (INDELs), copy number variations (CNVs), microsatellite instability (MSI), fusions and oncogenic pathogens in more than 60 targeted genes, in formalin-fixed paraffin-embedded (FFPE) tissue specimens.

The OncoKey™ SL 60 Plus Assay, available for research use, is intended for use on the automated Sentosa™ NGS workflow using Sentosa™ SX101,in conjunction with Illumina® Miseq™ or NextSeq™ sequencing systems. The workflow requires as little as 40 ng DNA or RNA per library and detects mutations as low as 5% variant allele frequency.

The automated workflow reduces hands-on time to a minimum and provides completely automated reporting of QC and test results for cancer samples. Data can be further analyzed with the VELA™ Analytics software, which provides a comprehensive interpretation of clinically actionable variants and variant categorization according to professional guidelines.

“Genetic mutation testing aids physicians in selecting the appropriate cancer treatment for patients, and provides insights into cancer prognosis. Our OncoKey™ SL Plus panels offer a cost-effective and flexible solution that targets clinically relevant genes for the most common cancer types, providing clinical insights in precision medicine research,” said Dr. Charlie Lee, Head of Research and Development.

The OncoKey™ SL 60 Plus Assay is the first product in Vela Diagnostics’ OncoKey™ SL portfolio that provides flexible automated NGS solutions for oncology to laboratories. Upcoming solutions include the OncoKey™ SL 190 Plus and OncoKey™ SL 525 Plus assays, which will be able to provide even greater genomic coverage across multiple cancer types.  

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’ Automated COVID-19 Detection Test Approved for Use in Australia

Singapore, August 26 2020– Vela Diagnostics announced today that the ViroKey SARS-CoV-2 RT-PCR Test v2.0 has been approved by the Australian Therapeutic Goods Administration (TGA) for in vitro diagnostic use. 

The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is a reverse transcription-polymerase chain reaction (RT-PCR) test that detects SARS-CoV-2 by targeting conserved regions on the SARS-CoV-2 genome, specifically the ORF1a and genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument and works in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The workflow tests up to 46 samples in a single run, with minimal hands-on time required. 

“This timely approval from the TGA for our automated test will allow Vela Diagnostics to facilitate efficient testing for suspected COVID-19 patients in Australia,” said Sam Dajani, acting CEO and Chairman of the Board.

To date, the ViroKey SARS-CoV-2 RT-PCR Test v2.0 has received the CE mark for Europe and the provisional authorization 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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FDA issues Emergency Use Authorization to Vela Diagnostics' Coronavirus PCR test

Fairfield, New Jersey, August 6, 2020– Vela Diagnostics announced that the manual version of its coronavirus PCR test has obtained Emergency Use Authorization from the U.S. Food and Drug Administration (FDA). By targeting conserved regions of the viral genome, the probe-based reverse transcription PCR test detects SARS-CoV-2, the coronavirus that causes COVID-19. The EUA allows the emergency use of FDA medical products in qualified labs, thus facilitating widespread access to the diagnostic test.

"RT-PCR is currently the gold standard for diagnosing SARS-CoV-2 infections. Given the escalating number of COVID-19 cases in the U.S., Vela Diagnostics is helping Americans get tested so as to detect and slow the spread of the virus,” said Sam Dajani, interim CEO and Chairman of the Board. “Our coronavirus test will assist healthcare professionals in managing the COVID-19 pandemic."

The ViroKey™ SARS-CoV-2 RT-PCR Test detects SARS-CoV-2 in nasopharyngeal and oropharyngeal swabs.The manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test enables flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments. For high throughput testing, Vela Diagnostics has also developed an automated version of the assay optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa™ SA201 instrument.

In addition to being authorized by the FDA for emergency use, the ViroKey™ SARS-CoV-2 RT-PCR Test has also received the CE mark and provisional approval 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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Vela Diagnostics receives CE-IVD approval and Provisional Authorisation from the Health Sciences Authority in Singapore for automated COVID-19 detection test

Singapore, July 13, 2020– Vela Diagnostics announced today that an automated version of its COVID-19 detection test, the ViroKey SARS-CoV-2 RT-PCR Test v2.0, has received the CE mark for in vitro diagnostic use as well as Provisional Authorisation from the Health Sciences Authority in Singapore.  

The ViroKey SARS-CoV-2 RT-PCR Test v2.0 is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome, specifically the ORF1a and genes. The automated test is optimized for a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx. The automated workflow enables high throughput testing with significantly reduced hands-on time. Up to 48 tests, including controls, can be performed in a single run. “Receiving CE certification and Provisional Authorisation from the Health Sciences Authority in Singapore for our automated test facilitates efficient testing of SARS-CoV-2 in patients suspected of COVID-19 in Europe, Africa, Middle East and Asia, where there is an urgent need to identify individuals infected with SARS-CoV-2 for effective management of the global pandemic,” said Managing Director, Andreas Goertz.

In April this year, an earlier version of the test, the ViroKey SARS-CoV-2 RT-PCR Test, also received the CE mark and Provisional Authorisation from the Health Sciences Authority in Singapore. 

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 Launches Next-Generation Sequencing-Based Assay that Detects Drug Resistance Mutations in Human Immunodeficiency Virus, Hepatitis C Virus, Hepatitis B Virus and Cytomegalovirus

Singapore, May 11 2020 - Vela Diagnostics announced that it has launched the ViroKey™ SQ FLEX Genotyping Assay (4x16). The assay is a next-generation sequencing-based test that detects drug resistance mutations (DRMs) in nucleic acids from the Human Immunodeficiency virus (HIV-1), Hepatitis C virus (HCV), Hepatitis B virus (HBV) and Cytomegalovirus (CMV).

HIV-1, HCV, HBV and CMV are major viral pathogens and millions around the world live with HIV-1, HCV, HBV and CMV infections. As a result of widespread antimicrobial drug use, antimicrobial resistance of these viruses has escalated in recent years. “Drug resistance of HIV-1, HCV, HBV and CMV is a rising problem and there is a need to identify DRMs in these pathogens for effective monitoring and treatment of patients. However, it may be cost-prohibitive for laboratories which process low or varying sample volumes of these assays to provide a quick turnaround time or to even offer these tests. A cost-effective and flexible solution is needed,” said Dr. Charlie Lee, Head of Research and Development. 

The ViroKey™ SQ FLEX Genotyping Assay (4x16), available for research use, consists of 4 tests that are performed on Vela Diagnostics’ automated workflow consisting of the Sentosa™ SX101, Sentosa ST401 and Sentosa SQ301 instruments.

  • The HIV-1 test detects mutations in the protease, reverse transcriptase and integrase regions of the pol gene of the Group M subtypes.
  • The HCV test detects DRMs in the NS3, NS5A and NS5B genes.
  • The HBV test detects mutations associated with drug resistance in the reverse transcriptase, surface gene, basal core promoter, pre-core and core regions.
  • The CMV test detects mutations in the UL54, UL97, UL56, UL51, UL27 and UL89 genes that confer resistance to antiviral drugs.

A unique feature of the ViroKey™ SQ FLEX Genotyping Assay (4x16) is that it enables laboratories to process up to 16 samples (including controls) of any combination of the 4 tests simultaneously in a single run. This game-changing flexibility to combine multiple tests into a single run provides laboratories with a highly cost-effective solution as they can now batch tests that are of lower volumes with tests that are of higher volumes. Moreover, laboratories with sufficient volumes for single tests retain the flexibility to perform individual tests in a single run using the same assay.

While the ViroKey™ SQ FLEX Genotyping Assay has an initial offering of 4 genotyping tests (HIV-1, HCV, CMV and HBV), there is potential for other virology tests to be brought onto the same platform. For example, an application that allows laboratories to combine HIV proviral DNA samples, extracted via their own methods, with HIV plasma samples on the same run using the HIV-1 test was recently developed on request.

The ViroKey™ SQ FLEX Genotyping Assay (4x16) is the latest product in Vela Diagnostics’ FLEX portfolio that provides flexible automated solutions for NGS and qPCR to laboratories. Previously, Vela Diagnostics developed a flexible automated workflow solution on its qPCR platform to detect and quantify up to 4 viruses that cause disease in immunocompromised individuals in one run.

About Vela Diagnostics

Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while enabling tests to be performed for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. 

All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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Vela Diagnostics Receives CE mark for COVID-19 Detection Test

Hamburg, Germany, 24 April 2020 – Vela Diagnostics announced today that the manual version of the ViroKey™ SARS-CoV-2 RT-PCR Test has received the CE mark for in vitro diagnostic use. The test detects SARS-CoV-2 in patients suspected of COVID-19 by their healthcare providers.

The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments.

“The CE mark enables Vela Diagnostics to expand COVID-19 testing capacity in Europe, where there is an urgent need to identify individuals infected with SARS-CoV-2,” said Sam Dajani, acting CEO and Chairman of the Board.

Vela Diagnostics has also developed an automated version of the test which is slated for CE-IVD registration in April 2020. The automated ViroKey™ SARS-CoV-2 RT-PCR Test is optimized for a workflow consisting of the SentosaSX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx.

About Vela Diagnostics

Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. 

All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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Vela Diagnostics Receives BARDA Funding to Develop COVID-19 Tests

Fairfield, New Jersey, April 20 2020 - Vela Diagnostics has been awarded a $225,000 contract by the Biomedical Advanced Research and Development Authority (BARDA) part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, to develop manual and automated tests to detect SARS-CoV-2, the virus that causes COVID-19.

The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR test that detects the virus by targeting conserved regions of the SARS-CoV-2 genome.

Under the agreement, Vela Diagnostics will perform verification and clinical validation of the ViroKey™ SARS-CoV-2 RT-PCR Test to be used on automated and manual workflows for Emergency Use Authorization (EUA) submission to the U.S. Food and Drug Administration (FDA). Support from BARDA is expected to accelerate the progress toward EUA submission.

The automated ViroKey™ SARS-CoV-2 RT-PCR Test is performed on a workflow consisting of the Sentosa™ SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time (ABI 7500 Fast Dx) PCR instrument or the Sentosa™ SA201 instrument.

Up to 48 samples (including positive and negative controls) can be processed per run on the automated workflow. The manual assay was developed to enable flexible sample processing and quick adoption of the test by laboratories with existing ABI 7500 Fast Dx instruments.

High volume testing of SARS-CoV-2 is also critical in mitigating the rapidly evolving COVID-19 pandemic. The CDC recommends COVID-19 testing for individuals with symptoms associated with COVID-19 such as fever and acute respiratory illness.

“High throughput detection of SARS-CoV-2 using our automated workflow will provide rapid and valuable information to save lives,” said Sam Dajani, acting CEO and chairman of the Board. “The funding from BARDA will enable Vela Diagnostics to increase the domestic and global testing capacity for COVID-19 to curb further spread of the virus.”

“Rapid diagnostic tests put essential information into the hands of healthcare providers and patients to manage patient care safely and appropriately.  Data gathered from high-throughput testing aids public health officials in making decisions about community mitigation to combat the pandemic,” said BARDA Director Rick Bright, Ph.D.

To date, COVID-19 has affected 199 countries and territories around the world, with total cases exceeding a million in US, Europe and China combined and at least 100,000 fatalities worldwide. On March 11, the World Health Organization declared COVID-19 to be a pandemic.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, Division of Research Innovation and Ventures under Contract No. 75A50120C00039.

About Vela Diagnostics

Vela Diagnostics is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosaplatform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. 

All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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Vela Diagnostics’ COVID-19 Test Receives Provisional Authorisation From the Health Sciences Authority in Singapore

Singapore, April 16 2020 - Vela Diagnostics announced today that the ViroKey™ SARS-CoV-2 RT-PCR Test has received provisional authorisation from the Health Sciences Authority in Singapore. This allows the test to be supplied to healthcare institutions, private hospitals, medical clinics and clinical laboratories licensed under the Private Hospitals and Medical Clinics (PHMC) Act in Singapore.

SARS-CoV-2 causes COVID-19. The ViroKey™ SARS-CoV-2 RT-PCR Test is a probe-based reverse transcription PCR Test that detects SARS-CoV-2 by targeting conserved regions of the SARS-CoV-2 genome. The manual version of the assay enables quick adoption of the test by laboratories with existing Applied Biosystems 7500 Fast Dx (ABI 7500 Fast Dx) instruments. For high throughput testing, Vela Diagnostics has also developed a research use only (RUO) automated version of the test which is optimized for a workflow consisting of the SentosaSX101 instrument, in conjunction with the Sentosa™ SA201 instrument or the ABI 7500 Fast Dx.

“Timely detection of individuals infected with SARS-CoV-2 will save lives and curb the spread of the virus in this global pandemic,” said Sam Dajani, Acting CEO and Chairman of the Board.      

The test is also pending CE marking.

About Vela Diagnostics

Vela Diagnostics, headquarted in Singapore, is a leading provider of an automated IVD Next–Generation Sequencing (NGS) workflow in the global diagnostics market. VELA’s real-time PCR and NGS applications are available on an integrated Sentosa™ platform; this provides a unique ability to leverage one system for two workflows, while carrying out tests for various targets in order to answer current clinical and research questions, as well as to drive laboratory operational efficiency. All Sentosa™ products listed above are by Vela Diagnostics. For more information, visit www.veladx.com.

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