News

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June 2021

ISO 13485 certificate for our Quality-Management-System confirmed

On 13 April 2021, the ISO 1385 certificate of myPOLS Biotec was confirmed during the annual surveillance audit. A great achievement for the team!

ISO 13485 Certificate: Download in English
ISO 13485 Certificate: Download in German

Konstanz, 21.06.2021


Great News: Our Volcano3G® products support accelerated SARS-CoV-2 detection

Fraunhofer IMM manages to do qPCR tests to detect SARS-COV-2 in as short as 15 mins

Fraunhofer IMM run these tests with our Volcano3G® products. Read the full press release from Fraunhofer IMM here: https://www.imm.fraunhofer.de/en/press-publications/qpcr-15min.html

Want to know more about the Volcano3G® product family?

  • About the Volcano3G® product family (Link)
  • About Volcano3G® Volcano3G® RT-PCR Probe 2x Master Mix (Link)

 Konstanz, 11.06.2021

May 2021

Now availableas CE-IVD: Accelerating SARS-CoV-2 detection with shortened RT-PCR directly protocol from pharyngeal lavage (“gargle”) sample

myPOLS Biotec GmbH launches its successful SARS-CoV-2 detection kit in a CE-IVD validated variant: Volcano3G® Direct COVID-19 Kit IVD. The special feature: the CE-compliant validation is established for RT-PCR directly from “gargle” (pharyngeal lavage) samples.

Kit IVD stands out from other products on the market primarily due to three features:

  1. the use of pharyngeal lavage samples is validated.
  2. RNA extraction is not necessary: PCR is proven to work with non-purified samples.
  3. very fast* PCR protocol with primers and probes according to CDC design (* = < 1h depending on the speed of the real-time PCR cycler, applicable directly from “gargle samples” without priorRNA extraction).

In addition, the RT-PCR test is very cost-effective: the CE-IVD variant can be ordered for 490 Euro/100 reactions. The variant for general laboratory use (RUO) costs 390 Euro/100 reactions. Discounts are available for bulk orders. Both can be ordered directly from our online store.

Further links:

  • Press release, 21.05.2021: Now as CE-IVD: Accelerating SARS-CoV-2 detection with shortened RT-PCR directly from pharyngeal lavage sample
    (In German)
    (In English)
  • Volcano3G® Direct COVID-19 Kit  - IVD (Link to product page)
  • Volcano3G® Direct COVID-19 Kit - general laboratory use (Link to product page)

Konstanz, 25.05.2021

March 2021

Regular preventive testing: Hyperstone already does it - with a PCR gargle test from myPOLS Biotec

Hyperstone GmbH from Constance takes care of Corona prevention in the company and offers its employees voluntary PCR tests twice a week - free of charge. This testing is made possible by the SARS-CoV-2 monitoring service of myPOLS Biotec Gmbh.

Further links:

  • Press release, 25.03.2021: Regelmäßiges präventives Testen: Hyperstone macht es schon – und zwar mit einem PCR-Gurgeltest (in German) (LINK)
  • SARS-CoV-2 product page: SARS-CoV-2 Monitoring zur Corona-Prävention (in German) (LINK)
  • Hyperstone GmbH website (LINK)

Konstanz, 25.03.2021

February 2021

DiagnosticGrade - New quality seal for reagents ensures performance and compliance of IVD components.

The Johner Institute and myPOLS Biotec GmbH are creating a cooperation and working together on quality-tested reagent products. These products can be applied as component in your IVD in order to contribute to safe and efficient test results.  Reagent development and production meet the relevant requirements of the EU In Vitro Diagnostics Regulation (IVDR), which the cooperation partners express with the "Diagnosticgrade" seal.

For your IVDR compliant products you will receive from us:

DiagnosticGrade Seal

 

Further links:

  • To the product page: DiagnosticGrade (LINK)
  • Detailed DiagnosticGrade-Service-Page (LINK)
  • Pressrelease download - in english (LINK) and in german (LINK)

Konstanz, 19. Februar 2021

 

myPOLS Biotec informs about SARS-CoV-2 screening possibilities

Due to the successful SARS-CoV-2 screening at the University of Konstanz, myPOLS Biotec has compiled an information sheet describing this screening. We would like to contribute to the implementation of this successful model at other universities and offer our support.


Further links:
  • Press release of the University of Konstanz, 09.02.2021: Corona screening at the University of Konstanz shows success (in German) (LINK)
  • Information sheet for download (in German) (LINK)

Konstanz, 16.02.2021

 

November 2020

myPOLS Biotec has launched a direct SARS-CoV-2 RT-PCR detection kit

The kit is based on a research cooperation with the University of Konstanz. This cooperation developed a new rapid Covid-19 detection process accelerating SARS-CoV-2 detection by skipping RNA extraction (see News below). This process, is based on an innovative DNA polymerase, developed and produced by myPOLS Biotec.

myPOLS Biotec has now decided to offer the new process in a Direct SARS-CoV-2 RT-PCR detection kit w/o RNA extraction. The kit contains an in-house developed master mix and a duplex primer/probe mix for both SARS-CoV-2 (N1 gene specific) and RNaseP control. It´s for research use only.

To the product: Direct SARS-CoV-2 RT-PCR detection kit w/o RNA extraction

Related Press Release in German (PDF Download)

News published November 23, 2020

New reference 

The study in collaboration with the local University of Konstanz, research group of Prof. Hauck, has now been published in PLOS ONE: Detection of SARS-CoV-2 from raw patient samples by coupled high temperature reverse transcription and amplification

News published November 03, 2020

October 2020

15% off with order code OFFER2020 (Expires 2020-Nov-30 at 11.59 pm CET)*

We almost reach the end of 2020. Maybe you already plan for 2021 and want to fill up your stock? Use our special End-of-Year Offer: get 15% discount for our master mixes and polymerases! We deliver in 2020 or 2021, depending on your needs.

Have you already seen our newest product?

PlexTaq® 5x qPCR Multiplex Master Mix: A 5x master mix for multiplexing applications delivering you rapid, sensitive and reproducible quantification of DNA targets. Enter the product page!

Running RT-PCR tests?

Use our Volcano3G® RT-PCR Probe 2x Master Mix: A unique master mix with an engineered, truly thermostable Taq DNA polymerases with reverse transcriptase activity, fast start functionality due to a hotstart aptamer formulation and an already included lysis function for direct RT-PCRs (suitable for SARS-CoV-2/Covid-19 detections). All this for an attractive price. Enter the product page!

*This offer is limited to off-the-shelf products ordered with the special order code. Services, bulk amounts and customizations are excluded. myPOLS Biotec GmbH reserves the right to end this promotion at any time. Offers cannot be combined with other discounts or promotions. Expires November 30, 2020.

News published October 14, 2020

May 2020

A study in collaboration with the local University of Konstanz, research group of Prof. Hauck, has been published and can now be found on the medRxiv pre-print server: https://www.medrxiv.org/content/10.1101/2020.05.19.20103150v1

As shown in the study, Volcano3G® master mix can be used to reliably detect SARS-CoV2 in extracted samples using the CDC-approved N1 and RNaseP qPCR-assay. When using an additional, high-melting reverse transcription primer, Volcano3G master mix even displayed lower Ct values than other commercially available RT-PCR mixes.

Since RNA extraction is time consuming and the availability of the extraction kits is scarce due to the world wide demand, we additionally explored to detect SARS-CoV2 directly from raw, dry oral swabs. These swabs are simply rinsed with RNase-free water and the sample is then directly added to the RT-PCR reaction. With this setup, samples of patients with a medium to high viral load were accurately detected in agreement with the results of extracted RNA samples. Due to inhibitory effect of the raw sample on the reaction, however, the input of the diluted sample is too low to achieve a reliable detection of SARS-CoV2 in patients with mild symptoms (and hence low viral titers).

We are currently exploring ways to improve the sensitivity of this approach and to launch it as an official, approved diagnostic kit as soon as possible.

March 2020

myPOLS is upscaling Volcano3G® productions significantly in order to supporting the fight against Corona virus.

 

February 2020

We are proud to announce that HiDi DNA polymerase and HiDi Taq DNA polymerase are becoming gold-standard enzymes for mutation detections as recent publications in high-impact journals demonstrate. Please see below

H. Matsunari et al., describing genome edited clones and allele-specific PCR with HiDi DNA polymerase - Link to the scientific publication

M. Serif et al., describing TALEN-mediated gene knockouts and identification by HiDi DNA polymerase - Link to the scientific publication

T. Sakurai et al., describing a CRISP-Cas9 induced mutation identification method - Link to the scientific publication

August 2019

Ramon (our CEO) was giving a talk at the qPCR conference in Freising this spring. His talk was recorded and is now online available - have a look! (passwort protected video stream (psw is: GQ2019)

May 2019

After months of tedious work we are proud to announce that our Quality Management system has been certified according to the ISO-Norm 13485:2016 (more details can be found here)

https://www.biolago.org/2019/05/28/schluesselkomponente-in-vitro-diagnostik-mypols-biotec-ist-jetzt-iso-zertifiziert/

 

February 2019

We have successfully established a Direct from Blood Genotyping PCR mix!

Our "DirectBlood Genotyping PCR Mix" allows real-time PCR based genotyping without any previous DNA isolation, directly from blood samples!

Currently we are further developing specific SNP typing assays. They will be launched under research-use only as soon as possible. If you are interested, please provide us with the rs-number of the SNP your are interested in, to receive an individual quotation.

Further readings - Test-customers have already successfully published scientific articles by using our kit! Respective publications can be found here and here.