Bengaluru/Delhi, 23 March 2020: Ahmedabad-based CoSara Diagnostics, the first Indian company
to get regulatory approval for its Covid-19 test kits, aims to make nearly 10,000 kits daily to meet the
surging demand for its diagnostics solutions.

“That’s our current target and is subject to availability of raw materials. We are primed to begin
deliveries in a week’s time,” said a senior company official in an exclusive chat with eN-ABLE on
Monday.The company has yet to decide the selling price of its kits but it will be within the suggested
price by the Government of India.

Co Sara Diagnostics, is a joint venture with Co Diagnostics, based in Salt Lake City, Utah, USA and
Synbiotics, a group company of Ambalal Sarabhai Group. India’s drug controller, CDSCO( Central Drugs Standards Control Organization) gave CoSara Diagnostics its approval to manufacture its patented RT-PCR Covid-19 test kit, that provides rapid testing facility and results within 150 minutes.

Mr Mohal Sarabhai, Director of CoSara, said in a statement :“Presently there are 52
government-approved testing facilities and delivering the kits to those is the first target,”
in addition to pursuing 60 accredited private labs to conduct COVID-19 tests. “Overall,
our target market will be private as well as government labs.”

The COVID-19 test kits approved by the CDSCO were those originally designed by Co- Diagnostics, the first U.S. company to receive a CE marking for a COVID-19 diagnostic. “The high-quality tests built on our patented CoPrimer™ technology will have a positive impact on what is projected to be the largest healthcare market in the world,” said Dwight Egan, CEO of Co-Diagnostics. “Co-Diagnostics is honored that our joint venture has achieved such a significant milestone.”

CoSara was set up in September 2017 to manufacture a variety of approved active pharmaceutical ingredients for the global markets. CoSara said the method of detection is through Real time PCR machine and presence of fluorescence intensity in terms of graph. Minimum duration for confirmed result is around 2.5 hours. The test can be done in any RT PCR machine having channels for FAM & CF 610 i.e. green & orange channels.

The highlights of the kits are:

Application	Qualitative multiplex PCR test for detection of SARS-CoV-2 (COVID-19) gene RdRp
Type of Detection	Ribonucleic acid (RNA0 of SARS-CoV-2
Limit of Detection	9.35 x 103 copies/mL
Sensitivity	100.00 %
Specificity	100.00 %
Sample Type	Lower respiratory tract specimens (eg. Bronchoalveolar lavage, sputum, tracheal aspirate) and upper respiratory tract specimens (eg. Nasopharyngeal fluids, nasal swab)
Thermocycler Run Time	63-90 minutes, depending on PCR equipment
Thermocycler Validation Capability	2 channel dyes: FAM and CF610 (Cat Fluor Red 610) CoDx Box (BioMolecular Systems) MIC Qpcr Cycler (BioMolecular Systems) Eco 48 (PCRmax)
Extraction Systems Validation Capability	QI Aamp RNA Viral Mini Kit (Qiagen, cat # 52904, 52906) Sbeader Blook Kit (Biosearch Technologies, cat # NAP 44401, NAP 44410, NAP 44100)

 

 

Some of the company’s future plans include:

• State of the art molecular diagnostic reagents manufacturing company under the joint venture with CO-DIAGNOSTICS INC-USA.
• Establishing state of the Art Molecular Diagnostic Testing Laboratories in various parts of Gujarat State.
• Using the power of computers to create unique mathematical models instead of relying on costly laboratory infrastructure. A revolutionary DNA-based testing platform, resulting in tests that are faster, much more affordable, flexible; simple to use, accurate, and adaptable to both high-volume and portable, low-cost analytical devices.

Mr Mohal Sarabhai, Director of CoSara, said in a statement: “Presently there are 52 government-approved testing facilities and delivering the kits to those is the first target,” in addition to pursuing 60 accredited private labs to conduct COVID-19 tests. “Overall, our target market will be private as well as government labs.”