Cutting complete blood count tests from days to minutes

Danny Levner: Complete blood counts are actually the most prevalent blood tests worldwide. It’s one of those tests that’s in the first line of questions for a doctor and it’s one of the older tests.

Even though it’s the most common test worldwide, it’s currently done almost exclusively in large labs and in that context the technology is quite mature and does a very good job. The problem is, at least with my experience in the US, when I go to the physician, the physician may choose to draw some blood but the results are only going to be available at least two days after the test. This means that the physician has to make an educated guess on my first visit about what may be wrong with me, which has consequences.

We’re not the only ones telling the story that testing needs to move closer to the doctor’s office so that it’s immediate and available on the first visit rather than the follow up. Even though it’s the most common test, this hasn’t happened and either the test is not available or when it is it always comes with some sort of compromise. So, the doctor has to say ‘do I want it done now or do I want it done well?’ What we’re doing is eliminating this compromise.

We keep a pretty tight eye on the market, we’ve seen some attempts and we are actually in touch with the strategic companies of some of the larger medical device manufacturers. Some people may have made claims but they certainly haven’t gone to the level of clinical validation that we have around our technology.

Part of the reason for breaking our silence recently is that we have finished a solid medical trial in a hospital in Israel with very positive results and we’ve actually started a trial in the US for the FDA. So, we’re the only ones that we feel have met that validation threshold and also that message has been reinforced by the larger manufacturers telling us that we’re on the right track.

We generally divide the technology into three pillars. The first part is called sample preparation, which is this process of digitising blood. Blood is very thick with cells and if you tried to image it as it is then you wouldn’t be able to see through it because it’s so dense. So, what we’ve done is create a process that allows the blood to create a nice thin layer that’s amenable to microscopy and to do so in a way that is really simple for the user.

The goal wasn’t to create something that only a trained medical professional would be able to use, but something that anybody would be able to use. So that’s the first accomplishment that we’ve developed this sample preparation process that’s unique to us and is patented. We’ve actually been awarded three US patents to cover that part of the process.

Next comes the imaging. The OLO instrument is actually an advanced automated microscope system inside a box and there is all sorts of technical innovations there to collect a very broad range of images. We don’t just take one simple picture of the blood, we actually illuminate it with a number of different optical wave lengths of light and we actually get a very informative set of images for each blood cell. The user interface is very iPhone like, easy to use and quick. We can perform the stats in less than ten minutes.

Last but not least is the artificial intelligence. In this section of the process, images are generated from the OLO instrument in real-time. As they’re being collected they’re being piped through this machine vision software and the on-board computer performs all the cell counting. This is flexible and we’ve already demonstrated that we can apply algorithms to different medical applications, the first one being malaria and the second one being complete blood count. We believe there is a whole slew of applications for these instruments.

So commercially the challenge now is to push the instrument into where it is now regulatory approved. We have regulatory approval to sell the product, which is primarily in Europe and some other countries that accept the CE mark so that’s path number one. Path number two is we’re very interested in the US market, which is why we’ve now been pursuing the regulatory process in the US. We have trials well underway in a couple of locations in the US.

The third branch is to think about the new applications of the technology and we have a whole pipeline of different applications that we’d like to integrate and actually envision OLO becoming a cornerstone of the physician’s office with many different tests being performed on OLO, but we’re taking a step by step approach by having a menu of different tests that we expand over time. The first additions are going to be things that enhance a blood count.

To give you one example, there are some cell types that can be seen in blood that are indicative of cancer and current instruments do a poor job of catching this type of cell, but we’ve already been able to show that we can actually see that type of cell quite clearly. One pretty immediate improvement would be to add a feature to the blood count that can test for this particular cell.

We haven’t gone public with the whole list but what I can say is we are interested in the detection of various common blood parasites and then we’re also interested in modalities that aren’t necessarily just looking at the blood cells themselves. For example, some genomic type tests could also be performed on our instruments.

For Europe, we’re able to start selling already, but what’s difficult is doing the pilot studies first before engaging in full on sales. We are currently trying to secure the initial pilot sales contracts in several European countries.

In the US, our regulatory strategy is set into two parts based on the FDA’s guidance. We plan to complete the first part around the middle of 2019 and that will allow us to sell to a pretty broad range of offices and labs although probably not yet to the individual smaller doctors’ offices. For that, we’ll need the second level of FDA approval and we expect to get that one in 2020.