INDUSTRYWEEK: Addressing Test Shortfall

Empirical Bioscience recently announced that its QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR kits have successfully tested in assays using EUA authorized qPCR detection kits following the CDC testing protocol.

The test amplifies and identifies genetic material from the SARS-CoV-2 virus that causes COVID-19 in one step. The QuanTASE RT-qPCR Assay Kits works by converting the CoV-2 RNA into DNA and amplifying to detect the presence of pathogenic material in patient samples.

The kit operates on most existing laboratory testing equipment in the United States, and it includes all the required RT-qPCR reaction reagents needed to run a COVID-19 test. It also meets the performance requirements for nCoV-2 testing established by the Centers for Disease Control (CDC) when used in accordance with CDC guidelines and in conjunction with an approved detection kit.

Designed to be comparable to other one step Rt-qPCR kits on the market, Empirical developed its test to supplement the current shortfall in the market for use in various testing facilities with minimal disruption to existing processes. Empirical has adjusted its production rates. “We are ramping up our production capacity from 50,000 kits a week to 100,000 a week,” said Empirical Bioscience President Des O’Farrell.

Continue reading at IndustryWeek…

PRESS RELEASE: Empirical Bioscience Donating COVID-19 Profits to Kids’ Food Basket

Empirical Bioscience, a company that produces high-grade reagents and enzymes for the life science industry, announced today that 10 percent of their COVID-19 revenue will be donated to the Kids’ Food Basket.

“We recognize that this is a particularly challenging time for families facing food insecurity,” said Des O’Farrell, President of Empirical Bioscience, “especially those with children that rely on school meals. The
need to provide our kids with nourishing food has never been more critical. A healthy diet goes hand-in-hand with maintaining a strong immune system. Our monetary commitment will allow the Kids’ Food Basket to secure more nutritious food to distribute to local families during this crisis and help minimize the impact of COVID-19 in West Michigan.”

Empirical Bioscience is committed to supporting the effort to defeat COVID-19 and other pathogens. In addition to their donation, the company offers a full range of Molecular Biology reagents to original equipment manufacturers (OEM) and laboratories to support their testing and research. Empirical Bioscience products being used in the fight against COVID-19 and other pathogens include, RTScript ™

Reverse Transcriptase, QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR Kits, DNA Polymerases, Custom MasterMix solutions and sample processing kits for RNA extraction and preparation.

Download press release.

LAB MANAGER: Empirical Bioscience’s 2019 RT-qPCR Kit Available For Use in nCoV Assay Testing

Empirical Bioscience announced today (Apr. 3) that their QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR Kits have been successfully tested in assays using EUA authorized qPCR detection kits using the established Centers for Disease Control (CDC) testing protocol.

The test amplifies and identifies genetic material from the SARS-CoV-2 virus that causes COVID-19 in one step. The QuanTASE RT-qPCR Assay Kit works by converting the CoV-2 RNA into DNA and amplifying to detect the presence of pathogenic material in patient samples.

In addition to its efficient design, the kit operates on most existing laboratory testing equipment in the United States, and it includes all of the required RT-qPCR reaction reagents needed to run a COVID-19 test. It also meets the performance requirements for nCoV-2 testing established by the CDC when used in accordance with CDC guidelines and in conjunction with an approved detection kit.

The kit’s attributes lend themselves well to the growing need for real-time COVID-19 testing. The company expects the demand for the kits to continue accelerating and they’ve adjusted their production and delivery time accordingly. “We are ramping up our production capacity from 50,000 kits a week to 100,000 a week,” said Des O’Farrell, president of Empirical Bioscience. “We are also offering 24-hour shipping.”

Continue reading at Lab Manager…

BIOSPACE: Empirical Bioscience’s 2019 RT-qPCR Kit Available For Use in nCoV Assay Testing

Empirical Bioscience announced today that their QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR Kits have been successfully tested in assays using EUA authorized qPCR detection kits using the established CDC testing protocol.

The test amplifies and identifies genetic material from the SARS-CoV-2 virus that causes COVID-19 in one step. The QuanTASE RT-qPCR Assay Kits works by converting the CoV-2 RNA into DNA and amplifying to detect the presence of pathogenic material in patient samples.

In addition to its efficient design, the kit operates on most existing laboratory testing equipment in the United States, and it includes all of the required RT-qPCR reaction reagents needed to run a COVID-19 test. It also meets the performance requirements for nCoV-2 testing established by the Centers for Disease Control (CDC) when used in accordance with CDC guidelines and in conjunction with an approved detection kit.

Continue reading at BioSpace…

PRESS RELEASE: Empirical Bioscience’s 2019 RT-qPCR kit available for use in nCoV Assay Testing

Empirical Bioscience announced today that their QuanTASE and QuanTASE PLUS One Step RT-qPCR RT-qPCR Kits have been successfully tested in assays using EUA authorized qPCR detection kits using the established CDC testing protocol.

The test amplifies and identifies genetic material from the SARS-CoV-2 virus that causes COVID-19 in one step. The QuanTASE RT-qPCR Assay Kits works by converting the CoV-2 RNA into DNA and amplifying to detect the presence of pathogenic material in patient samples.

In addition to its efficient design, the kit operates on most existing laboratory testing equipment in the United States, and it includes all of the required RT-qPCR reaction reagents needed to run a COVID-19 test. It also meets the performance requirements for nCoV-2 testing established by the Centers for Disease Control (CDC) when used in accordance with CDC guidelines and in conjunction with an approved detection kit.

The kit’s attributes lend themselves well to the growing need for real-time COVID-19 testing. The company expects the demand for the kits to continue accelerating and they’ve adjusted their production and delivery time accordingly. “We are ramping up our production capacity from 50,000 kits a week to 100,000 a week,” said Des O’Farrell, President of Empirical Bioscience. “We are also offering 24 hour shipping.”

Besides the QuanTASE RT-qPCR Kit, the company also offers a full range of Molecular Biology reagents to original equipment manufacturers (OEM) and laboratories to support their testing and research. Other Empirical Bioscience products being used in the fight against COVID-19 and other viral pathogens include, RTScript™ Reverse Transcriptase, DNA Polymerases, Custom MasterMix solutions and sample processing kits for RNA extraction and preparation.

Empirical Bioscience produces high-grade reagents and enzymes for Molecular Biology applications in its ISO 13485:2016 certified and FDA Registered facility in Grand Rapids, MI, USA and is a Registered Small Business Company.

BIOPORTFOLIO: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience, a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate.

Continue reading at BioPortfolio…

GRAND RAPIDS BUSINESS JOURNAL: announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems

Empirical Bioscience announced it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

GENOMEWEB: Empirical Bioscience Receives ISO 13485:2016 Certification for Medical Device and Quality Management Systems

Empirical Bioscience said this week that it has received ISO 13485:2016 certification for Medical Device and Quality Management Systems, which is an upgrade from its previous ISO 13485:2003 certificate. This new certification more closely aligns with US Food and Drug Administration regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry, the firm said. ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing, and sale of medical devices that are safe and effective for their intended purposes. To receive such a certification, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

Read more at Genomeweb

BIOSPACE: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

Continue reading at BioSpace…

PRESS RELEASE: Empirical Bioscience Upgrades to ISO 13485:2016 Certification

Empirical Bioscience, a privately-held developer and manufacturer of enzymes, polymerases, and reagents for Molecular Biology applications, announced that it has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems, this is an upgrade from their ISO 13485:2003 certificate. This certification more closely aligns with FDA regulatory guidelines and is an international standard that outlines the requirements for a quality management system specific to the medical device industry.

ISO 13485:2016 is an internationally recognized quality standard intended to provide a quality framework focused on the consistent design, development, servicing and sale of medical devices that are safe and effective for their intended purposes. To be certified, organizations must demonstrate an ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

“This certification is further evidence of our commitment to quality and ensures every Empirical Bioscience customer – from research institutions to an OEM customer who purchases custom reagents and complete test kits – receives products and services of the highest standards for product performance, quality, consistency, and reliability,” said Beth Lowe, Quality Systems Manager of Empirical Bioscience. “With a focus on maintaining a world-class quality management system and as one of the few privately-owned companies in our market space, Empirical Bioscience is an organization that customers can confidently rely on to meet and exceed expectations,” said Des O’Farrell, President of Empirical Bioscience.

Empirical Bioscience produces high-grade PCR reagents and enzymes in its ISO 13485 certified facility in Grand Rapids, MI, USA and is a Registered Small Business Company.