Press Releases

Vela Diagnostics Submitting Novel Coronavirus Diagnostic Test to FDA for Emergency Use Authorization

Singapore, February 11, 2020 – Vela Diagnostics has developed the ViroKeyTM SA201 COVID-19 RT-PCR Test, a new diagnostic test for the detection of the COVID-19 coronavirus. Vela Diagnostics is currently in discussions with the U.S. Food and Drug Administration (FDA) for clearance of the test under the emergency use authorization (EUA). The EUA will allow the emergency use of FDA unapproved medical products in qualified labs, thereby facilitating widespread access to the diagnostic test. 

The ViroKeyTM SA201 COVID-19 RT-PCR Test will be officially available by end-February with the facility to pre-order now. 

The COVID-19 coronavirus was first identified in mid-December 2019 in Wuhan, China. Human-to-human transmission has been confirmed by China’s health ministry. According to Chinese health agencies, there are more than 40,000 confirmed cases with at least 900 fatalities in China, while over 200 cases have been confirmed in more than 20 other countries. These numbers are expected to increase. There is an urgent need for a fast, high-throughput and accurate diagnostic method to provide timely treatment for those infected and to prevent the spread of the virus.

 The ViroKeyTM SA201 COVID-19 RT-PCR Test will be able to detect and differentiate the COVID-19 coronavirus from other closely related coronaviruses such as SARS and MERS. To enable high-throughput processing of 96 samples in 4 hours, the test is configured for an automated workflow consisting of the SentosaTM SX101 instrument, in conjunction with the Applied Biosystems 7500 Fast Dx Real-Time PCR instrument (ABI 7500 Fast Dx) or the SentosaTM SA201. The SentosaTM SA201 platform also supports other tests such as the SentosaTM SA201 HSV-1/2 PCR Test (U.S. FDA cleared) and the SentosaTM SA201 ZIKV RT-PCR Test (for use under Emergency Use Authorization from the U.S. FDA). As time-to-market is critical to address the urgent need for the test, a manual kit will also be made available to facilitate the fast adoption of the test by laboratories with existing ABI 7500 Fast Dx PCR instruments.

Concurrently, Vela Diagnostics and Great Basin Scientific are co-developing a COVID-19 assay for use on Great Basin’s sample-to-result diagnostic system. The Great Basin system utilizes a disposable cartridge with fully integrated reagents and internal controls. The Great Basin automated bench-top analyzer performs all steps in the assay, visually interprets the results, and provides a digital report of the results. Great Basin is targeting to deliver a diagnostic result in under 90 minutes for the COVID-19 assay.

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

About Great Basin Scientific

Great Basin Scientific is a molecular diagnostics company that commercializes breakthrough chip-based technologies. Great Basin Scientific is dedicated to developing simple, yet powerful, sample-to-result technology and products that provide fast, multiple-pathogen diagnoses of infectious diseases. Our vision is to make molecular diagnostic testing so simple and cost-effective that every patient will be tested for every serious infection, reducing misdiagnoses and significantly limiting the spread of infectious disease. More information can be found on the company’s website at http://www.gbscience.com.

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Vela Diagnostics’ Next Generation Sequencing HIV Genotyping Assay receives approval from Singapore Health Sciences Authority

2019-12-09

Singapore Health Sciences Authority (HSA) approves Vela Diagnostics’ Sentosa® SQ HIV-1 Genotyping Assay for detecting HIV-1 drug resistance mutations (DRMs).

Singapore, Singapore (December 9, 2019) - Vela Diagnostics announced today that the Singapore Health Sciences Authority (HSA) has approved its Sentosa® SQ HIV-1 Genotyping Assay as a Class C IVD Device under the Priority Full Evaluation Route. The Sentosa® SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test.

“Singapore is at the forefront of molecular diagnostics and the approval of our NGS assay by HSA is a major milestone in HIV diagnostics for the region. With the Sentosa® SQ HIV-1 Genotyping Assay, laboratories will now have a highly specific and sensitive sample-to-report solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, acting CEO & Chairman of the Board.

The Sentosa® SQ HIV-1 Genotyping Assay is validated on the Sentosa® NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with seamless LIS integration and connectivity. 

The associated software uses standalone versions of the Stanford HIVdb, ANRS and Rega algorithms to generate a clinical interpretation report that provides information on drug resistances associated with the detected mutations.

Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa® SQ HIV-1 Genotyping Assay utilizing the Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (<2 hours combined), and turnaround time (2 days).

Resistance of HIV-1 to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in patients with HIV-1 infection. The detection and reporting of DRMs is crucial for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimens and can prevent or minimize the development of resistance to antiviral drugs. The World Health Organization (WHO) recommends monitoring and reporting early warning indicators (EWI) of HIV drug resistance as a key component of public health strategy when scaling up antiretroviral therapy. 

In November 2019, the assay was granted De Novo designation by the U.S. FDA, making it the first and only HIV-1 genotyping NGS assay currently available on the market to receive marketing authorization from the FDA. The assay is also pending review for the CE mark.

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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FDA Grants De Novo Designation to Vela Diagnostics’ Next Generation Sequencing HIV-1 Genotyping Assay

Vela Diagnostics’ Sentosa® SQ HIV-1 Genotyping Assay is the first FDA De Novo designated Next Generation Sequencing (NGS) assay for detecting HIV-1 drug resistance mutations (DRMs).

Fairfield, NJ (November 5, 2019) - Vela Diagnostics announced today that it has received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs). The Sentosa® SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first and only HIV-1 genotyping NGS assay currently available on the market to receive marketing authorization from the FDA.

“The granting of the De Novo designation of our NGS assay by the U.S. FDA is a major milestone in HIV diagnostics. VELA strives to bring relevant products to clinicians to help patients around the world.  With the Sentosa® SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, acting CEO & Chairman of the Board.

The Sentosa® SQ HIV-1 Genotyping Assay is validated on the Sentosa® NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with seamless LIS integration and connectivity. 

Using a standalone version of the curated Stanford University HIV Drug Resistance Database to ensure traceability of the DRM interpretation report, the system generates a clinical interpretation report that provides information on drug resistances associated with the detected mutations. 

Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa® SQ HIV-1 Genotyping Assay utilizing the Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (<2 hours combined), and turnaround time (2 days).

Resistance of HIV-1 to antiretroviral drugs as a result of DRMs is the most common cause of therapeutic failure in patients with HIV-1 infection. The detection and reporting of DRMs is crucial for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimens and can prevent or minimize the development of resistance to antiviral drugs. The World Health Organization (WHO) recommends monitoring and reporting early warning indicators (EWI) of HIV drug resistance as a key component of public health strategy when scaling up antiretroviral therapy. 

In 2017, an earlier version of the Sentosa® SQ HIV Genotyping Assay received the CE mark, and was approved by the TGA (Australian Therapeutic Goods Administration) and HSA (Singapore Health Sciences Authority). In August 2019, the assay received approval from the Thai FDA. In addition to receiving the FDA De Novo designation, the current configuration of the assay is pending review for the CE mark and from the HSA.

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’ Next Generation Sequencing HIV Genotyping Assay Receives Approval from Thai FDA

Thai FDA approves Vela Diagnostics’ Sentosa® SQ HIV Genotyping Assay Next Generation Sequencing (NGS) assay for detecting HIV-1 drug resistance mutations (DRMs). 

Singapore, Singapore (August 23, 2019) - Vela Diagnostics has received Thai FDA approval for its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations (DRMs).  In a single test, the Sentosa® SQ HIV Genotyping Assay detects HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene, using the plasma of patients infected with HIV-1.

“The approval of our NGS assay by Thai FDA offers a highly specific and sensitive diagnostic option for patients living with HIV in Thailand. With the Sentosa® SQ HIV Genotyping Assay, laboratories will now have a sample-to-result solution to aid in monitoring and treating HIV-1 infection,” said Sam Dajani, CEO & Chairman of the Board.

The Sentosa® SQ HIV Genotyping Assay is validated on the Sentosa® NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting. The workflow also offers clear sample traceability, with seamless LIS integration and connectivity. 

Compared to Sanger bi-directional sequencing and other non-automated NGS alternatives, the Sentosa® SQ HIV Genotyping Assay utilizing the Sentosa® NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (<2 hours combined), and turnaround time (2 days).

In 2018, it was estimated that 480,000 people in Thailand are living with HIV, with 6,400 new HIV infections every year. Resistance of HIV-1 to antiretroviral drugs is the most common cause of therapeutic failure in patients with HIV-1 infection. The detection and reporting of DRMs is crucial for optimal selection of Highly Active Antiretroviral Therapy (HAART) regimens and can prevent or minimize the development of resistance to antiviral drugs.

In 2017, the Sentosa® SQ HIV Genotyping Assay received the CE mark, and was approved by the TGA (Australian Therapeutic Goods Administration) and HSA (Singapore Health Sciences Authority). 

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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