Newtown-based Meridian Bioscience is deploying its newly developed test illumigene® Malaria in Dakar, Senegal and planning a rollout of this potentially life-saving diagnostic across Africa. A test for the Zika virus is under development and is expected to be ready in six to twelve months.
Meridian, known for its influenza, strep, rotavirus and other diagnostic tests using bodily fluids, faced a new challenge when developing a simple and accurate test using patient blood for malaria. Through a series of steps it looks for changes in the amount of light passing through a test tube.
Senior Director of Molecular Development Brian Loeffler and his team developed such a molecular test in a year, a third less time than normal.
https://www.youtube.com/watch?v=M71TvrQeJ2s
- A drop of blood goes into a container. This breaks open the cells and makes the DNA available.
- The blood goes into a filtered tube to remove all debris.
- Nucleic acid passes through.
- The blood then goes into a device with dried reagents with all of the enzymes and primers to amplify the nucleic acid.
- It is then mixed up and put into another device which heats the sample. The test makes copies of the DNA and light can tell if there is a positive result.
The old way of testing involved looking through a microscope to detect the malaria parasite. Scientists agree it wasn't very accurate. The new Meridian test can be read in 40 minutes by people who do not have a high level of technical expertise. It’s also 80,000 times more accurate than current tests for malaria.
Meridian was so serious about getting its malaria detection test to market in a year or less it hired a Cincinnati consulting firm. It also built a special communication room at its Innovation Center with walls that are still covered in colored post-it notes of things to do.
Why is this test so important and why did Meridian want to bring it to market so quickly?
Chief Technology Officer Ken Kozak says, "Every minute, while we do this interview, every minute, a child dies in Africa from this disease."
Kozak says accuracy is important because most people don't have the full-blown symptoms for a long time and inaccurate tests can have them back in society infecting others. There are two targets for the test:
- Natives of tropical and subtropical areas
- People who visit them, but don't live there.
Meridian is now working on a Zika virus diagnostic that will be better than current tests and more widely available.
According to CEO Jack Kraeutler, "You don't have to use a lot of imagination to recognize that there are other parasites and pathogens in blood where this technology could be used. We've been asked by some individuals at the CDC (Centers for Disease Control and Prevention) could we do Zika virus and we have prototypes already to be able to test for Zika virus in blood."
He says, "The company is obviously in business to develop tests and distribute them around the world, but the ones where you have a very close connection with the patient and you can really make a difference, I think that makes everybody feel good."
illumigene® Malaria is still awaiting FDA approval in the U.S.
