GFE and LVL Technologies strengthen supply of COVID-19 antigen tests

Frankfurt am Main; Crailsheim, March  12, 2021. – GFE and LVL Technologies today announced to strengthening their long cooperation for the current sales and support of PCL’s COVID-19 antigen rapid test, whereas both companies combine their specific core competences to strengthen the market position.

“This cooperation is a major milestone to address the increasing demands of the highly volatile COVID-19 market for continuous supply and very fast delivery processes” said Dr. Reiner Babiel, CEO at GFE.

“With our well established international logistic and supply chain we are well positioned to satisfy high logistical challenges in the current Corona pandemic.” comments Martin von Lueder, CEO at LVL.

GFE’s experiences in IVD products and regulations provides the solid basis for the regulatory compliance and a professional support of customers.

LVL’s strength in international logistics guarantees a well-established  supply chain for the increasing demands of the  antigen test market during the Corona pandemic.

Jointly the two companies want to provide superior customer experience and product availability to help successfully fighting the Corona crisis.

LVL is a privately owned company for laboratory supplies with a long history in MedTech and Pharma industries.

GFE is a wholly owned subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Blutspendedienst des Bayerischen Roten Kreuzes.

 

Contact:

LVL technologies GmbH & Co. KG
Theodor-Storm-Straße 17
74564 Crailsheim
T +49 7951 95613-20
www.lvl-technologies.com

GFE
Altenhöferallee 3
60438 Frankfurt am Main
T +49 69 400 5513-0
www.gfeblut.de

PoET HIV CE-IVD marked

Frankfurt am Main, March 12, 2021. – GFE announced the CE-IVD approval of its PoET HIV blood screening NAT test. The PCR kit is used on GFE’s new, fully integrated NAT testing solution, the PoET System. With this NAT test GFE continues its tradition as a leading provider of high-quality blood screening solutions.

“Despite a variety of powerful therapies, there is still no cure for or vaccination to prevent HIV infections. Therefore, transmission risk reduction particularly regarding transfused blood or blood components remains a key priority.” said Dr. Reiner Babiel, CEO at GFE. “Our Assay Development has redesigned the HIV assay, now allowing to detect all HIV clades including HIV-2 in one assay, either in screening or confirmatory format. In total five amplicons seamlessly work together to achieve superior performance and safety.”

The CE approval marks a major milestone in the launch process for the PoET product line. The PoET system features a fully automated instrument and on top of HCV, HBV and HIV an extensive menu for blood screening tests, including HAV, B19V, HEV and WNV. The market introduction of the PoET product line is scheduled for spring 2021.

The PoET HIV test features excellent sensitivity and a broad subtype coverage to effectively address the serology window period. The test is designed for mini pool testing as well as confirmatory testing of individual donations. Effective mini pool testing enables laboratories to increase sample throughput at lower costs per sample while maintaining very high blood safety standards.

GFE is a wholly owned subsidiary of the three German Red Cross organizations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Blutspendedienst des Bayerischen Roten Kreuzes.

GFE’s PoET HCV receives CE-IVD mark

Frankfurt am Main, January 22, 2021. – GFE today announced the CE-IVD approval of its PoET HCV blood screening NAT test. The PCR kit is used on GFE’s new, fully integrated NAT testing solution, the PoET System. With this NAT test GFE continues its tradition as a leading provider of high-quality blood screening solutions.

“Hepatitis C played a key role in establishing nucleic-acid based screening of donor blood in the late 1990ies. Since there is still no vaccination against HCV, sensitive screening remains an effective tool to control the spread of this virus.” said Dr. Reiner Babiel, CEO at GFE.

The CE approval marks another major milestone in the launch process for the entire PoET product line. The PoET system features a fully automated instrument and a series of blood screening tests. The market introduction of the PoET product line is scheduled for spring 2021.

The PoET HCV test features excellent sensitivity and a broad genotype coverage to effectively address the serology window period. The test is well suited for mini pool testing as well as confirmatory testing of individual donations. Effective mini pool testing enables laboratories to increase sample throughput at lower costs per sample while maintaining very high blood safety standards.

GFE is a wholly owned subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Blutspendedienst des Bayerischen Roten Kreuzes.

 

PCL and GFE cooperate on supply of superior Antigen SARS-CoV-2 rapid test

Seoul; Frankfurt am Main, 30. November 2020. – PCL Inc., and GFE today announced their cooperation to promote PCL’s CE-IVD certified “[COV04S] PCL COVID19 Ag Gold Saliva” rapid test in major parts of Europe. This antigen quick test facilitates the sample collection by testing directly with saliva. This approach for sampling reduces the discomfort of patients during sample collection, minimises the risk of insufficient sampling, and relieves medical personnel. Alternatively, nasopharyngeal swabs can be applied.  The test result is then available in just 10 minutes at very high sensitivity and specificity.

Without extra equipment being required for collection of saliva, processing or analysis, this straightforward lateral flow test is a great tool for professional application at point-of-care or in the laboratory. Hospitals, nursing rooms, companies, airports, or others with people suspected of COVID-19 could implement this rapid test to identify those reactive for SARS-CoV-2 antigen.

“With a production capacity of this kit at 1 million tests per week and a planned extension to exceed 4 million within the next weeks, we are well positioned for a game change in narrowing down the COVID-19 pandemic” said Soyoun Kim, Ph.D. CEO of PCL Inc. “With GFE’s experience in viral testing, we are pleased in having a competent partner for our business in Europe.“

“With the combined strengths of two fast moving companies in the in-vitro-Diagnostics field we are very much focused on providing state of the art and complementary technologies to our customers.” said Dr. Reiner Babiel, CEO at GFE. “The high quality of products and services, a reliable supply chain, and an unbiased focus on our customer’s needs are key pillars in our strategy. We are very pleased collaborating with PCL, which allows us expanding our portfolio of virus testing. Quickly identifying someone with suspected SARS-CoV-2 infection is completely in line with our diagnostic mission.”

Highly sensitive PCR tests might be applied to confirm positive or questionable results. The consequent, or if required, routine testing in appropriate settings will, particularly if applied in combination with other measures for risk reduction, contributing to fight the Corona pandemic.

GFE is a 100% subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Bayerisches Rotes Kreuz. The company provides NAT tests for the virus screening of millions of samples per year.

PCL, Inc., is a Global-Leading IVD (in-vitro diagnostic) company based on their own Sol-Gel CapTm technology which enables a single test to detect multiple bio-markers at the same time.  Specifically, PCL, Inc. is specialized in providing a multiplex diagnostic solution for high-risk virus and has cooperated with GFE for supplying Germany Blood Bank including Bavarian Red Cross with Blood Bank Virus Serology Screening Solution.

For further information:

GFE Gesellschaft zur Forschung, Entwicklung und Distribution von Diagnostica im Blutspendewesen mbH
Dr. Ralf Bartl
Tel.: +49 69 400 513 38
Email: sales@gfeblut.de
www.gfeblut.de
PCL Inc.
CEO, Soyoun Kim, Ph.D.
Tel.: +82 2 2144 3901
Email: pclchip@pclchip.com
www.pclchip.com

 

GFE received CE-IVD certification for new HBV PCR kit.

Frankfurt am Main, 23. November 2020. – GFE today announced the CE-IVD approval of its PoET HBV Kit for use with the new, fully integrated NAT testing solution, the PoET System. With this kit GFE pursues its tradition as a leading supplier of high-quality blood screening solutions.

“GFE is proud to preparing the launch of the successor product line for the autoX-System, which is used for automated testing of millions of blood donations every year.” said Dr. Reiner Babiel, CEO at GFE. “We have upgraded the Hepatitis B assay to a dual-target design, which allows a highly sensitive and reliable detection of the virus. This superior design was introduced successfully in the PCR diagnostics more than 10 years ago and has since been mandated by Paul-Ehrlich-Institute in Germany for HIV screening to further minimize the risk of missing virus variants.”

This is a major milestone in the launch process for the entire PoET product line providing automation and a series of blood screening kits. The market introduction will be jointly with a set of products in early spring 2021.

With HBV being one of the most widespread and chronic infections, particularly in Asia and Africa, GFE has focussed on an exceptional sensitivity and robustness of this assay. This very well goes along with GFE’s preferred strategy of mini pool testing, supporting lower costs per sample and an increased throughput.

GFE is a 100% subsidiary of the three German Red Cross organisations DRK Blutspendedienst West, DRK Blutspendedienst NSTOB, and Bayerisches Rotes Kreuz.

virtual ISBT 2020

Meet us at the virtual ISBT 2020, December 12 – 16.
See the latest information on NAT blood screening and SARS-CoV-19 testing.

ISBT 2019

Meet us at the ISBT 2019 in Basel.

DGTI 2019

51. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie e.V. (DGTI), Congress-Centrum Rosengarten Mannheim, Rosengartenpl. 2, 68161 Mannheim, Germany