May 5, 2020

Grifols completes development of very high sensitivity molecular test to detect SARS-CoV-2 virus

Download PDF
  • The company has developed the test in record time in a global coordinated effort of its facilities in San Diego, Barcelona and Bilbao, and has recently received the authorization of the Spanish Medicines and Medical Devices Agency (AEMPS) for its use in blood, plasma and respiratory samples.
  • Grifols has a productive capacity of one million tests weekly in its plant in San Diego, U.S.

  • The test technology, proprietary to Grifols, has a high sensitivity and specificity and uses the company’s own Procleix® platform, through the Panther® analyzer, a completely automated system with a high throughput capacity per day

Barcelona, May 5, 2020 - Grifols (MCE: GRF, MCE: GRF.P, NASDAQ: GRFS), has announced today it has completed the development of a specific TMA (Transcription-Mediated Amplification) molecular test that permits the detection of the SARS-CoV-2 virus in plasma, blood and respiratory samples, with a sensitivity equal or even superior to that of other molecular tests currently available, such as those based on PCR.

Thanks to this high sensitivity, the molecular test will also permit testing of pools of samples (pool strategy), multiplying the capacity of testing the population.

The TMA test is a complete and automated testing solution that includes all the reagents, from the preparation of the sample to getting a result. It is processed on Procleix® Panther® systems, each unit with an analysis capacity of more than 1,000 samples daily.

“Having sufficient molecular test capacity is critical to helping control this pandemic, and having a high-sensitivity test to handle a possible ‘pooling’ strategy is, without a doubt, a differentiating factor, which could make it feasible,” said Victor Grifols Deu, Grifols co-CEO. 

The collective effort of teams in San Diego, Bilbao and Barcelona has enabled the accelerated test development and production in less than three months

Grifols began developing its test to detect SARS-CoV-2 the first week of February, thanks to the combined efforts of its teams in San Diego (U.S.), Bilbao and Barcelona (Spain).

The design and manufacturing of the test took place in its San Diego facilities, where Grifols has its worldwide production of this type of test based on Transcription-Mediated Amplification technology, proprietary to Grifols.

Subsequently, the tests were validated in respiratory samples in the Grifols-Progenika laboratories in Bilbao, which have extensive experience in the development and validation of molecular diagnostic tools in any type of clinical sample.

“All of Grifols’ talent gave their complete dedication to develop, produce and validate this test in record time, an exceptional example of teamwork. We are very proud of the effort and commitment of our collaborators during these unprecedented times of crisis,” said Raimon Grifols Roura, Grifols co-CEO.

Grifols, with more than 100 years of history, is a global leader in diagnostic solutions and a standard in blood and plasma donation safety in countries such as the U.S. and Japan.