Affigenix get regulatory nod to make 3 COVID-19 home-made diagnostic kits

Bangalore, 14 Sept 2020: Affigenix founder, Dr Arumugam Muruganandam informed that the license to manufacture, sale and distribution of these three kits—Affimag, Affispin and COVID-19 test kit was received from the drug reglator, CDSCO/DCGI on 10 September 2020.

Dr Muruganandam said Affigenix had developed two COVID-19 RNA isolation kits namely AffimagTM (magnet based), AffispinTM (spin column based) with the funding from IKP-ICO. In June 2020, the company received the performance evaluation report for these two kits from the Indian Council of Medical Research(ICMR).

Also, the company had developed the Affigenix COVID-19 Test (ACTTM) RT-QPCR kit for diagnosis of COVID 19 infection under the same program. ICMR gave the performance report for this kit in July 2020.

ICMR performance evaluation report for AffimagTM was received on June 5th, AffispinTM on June 10th and ACTTM kit on July 15th .

Not just India. These kits could be soon available in other parts of the world. Dr Muruganandm said Affigenix has been selected by Millennium Alliance for grant-in-aid to scale up and supply of these kits to regions of South East Asia and African countries. Affigenix has also been chosen for grant by DBT-BIRAC to develop Immunogenicity ELISA for community screening.

Affigenix’s Target Multiplex RT-qPCR kit is a qualitative robust clinical laboratory test based on real time PCR.

  • The kit component includes ready to use real-time reverse transcription polymerase chain reaction mix and primer - probe sets designed to detect specific RNA sequences from individuals suspected of COVID-19 infection.
  • The assay targets highly specific and conserved regions of the COVID-19 such as N gene and Orf 1ab gene fragment for the detection of COVID-19.
  • Includes all reagents required to analyze RNA samples for performing RT- qPCR.
  • Throughput – Can screen upto 45 samples in one single run

AFFIMAG COVID-19 viral RNA isolation kit is developed for the isolation of viral RNA using magnetic beads and unique buffer system. The samples lysed will be using lysis buffer and the released nucleic acid will then specifically bind to paramagnetic beads which will be captured using magnetic stand. Cycles of wash buffer containing alcohol is used to remove the contaminants. The highly pure nucleic acid is eluted using low salt elution buffer. The obtained highly pure RNA can be directly used for downstream applications like PCR and RTqPCR

The AFFISPIN COVID-19 viral RNA isolation kit is designed for the isolation of RNA for nucleic acid amplification and quantitative RT-qPCR study.

ABLE member, Affigenix Biosolutions, a startup based in Bangalore, can now start manufacture and sale of three diagnostic kits, Affimag, Affispin and Affigenix COVID-19 test (ACT) RT-QPCR kits for diagnosis of COVID-19.

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