The Central government has put out a notice that it has not approved Bione’s home kit for the self-testing of coronavirus. This comes after several news outlets reported on Friday that the Bengaluru based company “Bione” has launched a new home testing kit of COVID-19.
Drugs Comptroller of India, Dr VG Somani, stated that “CDSCO, the competent authority for coronavirus diagnostic kits, has not licensed the diagnostic kit by Bione.”
CDSCO stands for Central Drugs Standard Control Organisation.
The All India Drug Action Network (AIDAN), an organisation which works to promote transparency in the pharmaceuticals field in India, wrote to the Drugs Comptroller of India to know whether the government had approved the kits which Bione was marketing.
In the letter, AIDAN said, “Bione's activities are a mockery of the government policy of clinical judgement and physician's prescription for COVID19 testing. The company's strategy is clearly to exploit public anxiety around the pandemic in order to make a killing. It is selling kits to the general public even before official directions regarding the use of rapid antibody tests have been issued, and even while the interim advisory of 2 April 2020 for use of antibody tests in hotspots does not support indiscriminate self-testing by the public.”
Bione, which describes itself as “India's 1st consumer Microbiome and Genetic testing organisation,” was reportedly marketing the test which checks for antibodies in the blood. According to the letter put out by AIDAN, “It is impossible to determine the genuineness of the test kit, which resembles a pregnancy test in appearance.”
The sample is reportedly taken through a pinprick, and is fed into the kit. The kit reportedly gives a result within 15 minutes, and is priced at Rs 2000-3000.
AIDAN’s letter stated that the first batch was sold out on the company’s website, but TNM found that the company website is no longer listing the test kit for coronavirus.
However, the company is also marketing two other related kits. “MyMicrobiome Kit”, priced at Rs 16,500, supposedly analyses the microorganisms in your gut. According to information available on their website, “Gut Microbiome can show how strong you are to fight infections like coronavirus. Gut Microbiome test is the only way to know when the virus is no longer in your system.”
The second test, “COVID-19 Genetic Susceptibility kit”, priced at Rs 15,000, claims to tell the user how susceptible they are to the virus. "Bione COVID-19 Genetic Susceptibility Test detects specific gene variants present in your DNA that can be responsible for making you more sensitive to certain viruses like coronavirus, HIV, Influenza, etc. If the test result shows that you are more susceptible to viruses, you will be provided genetic counselling,” the company states.