Sight Diagnostics - AI Based Fastest Blood Testing Device
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Sight Diagnostics – “OLO” AI Based Fastest Blood Testing Device

Introducing – Sight Diagnostics, an Israeli Biotech Startup which is using Artificial Intelligence to fasten up the blood test process. Recently they have successfully pooled in $27.8 million Series C funding round. The funding is led by VC firm Longliv Ventures and also is a part of the conglomerate CK Hutchison Group.

The company has built a machine, called OLO, which analyzes cartridges packed with drops of the individual’s blood counts in situ.

Image courtesy: Sight Diagnostics

Sight Diagnostics said it was after strategic investment to its Series C — especially investors who could give rise to its own technological and commercial expansion. And on that front CK Hutchison Group’s portfolio comprises more than 14,500 wellness and beauty shops across Asia and Europe, giving a crystal clear go-to-market route for the OLO blood testing device of the company.

Sight Diagnostics also notes that it is searching for additional strategic partners that will allow it to get its device to “major markets across the world”.

The company said it expects that customers across “multiple countries in Europe” will have deployed OLO in actual use this past year.

The MedTech startup, which was founded back in 2011, has increased more than $50M so far, only disclosing its Series A and B raises past year.

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Although its first go-to-market push has concentrated on Europe — where it has obtained CE Mark registration for OLO (required for commercial sale in certain European nations) after a 287-person clinical trial and went on to start the device last summer. It’s since signed a supply arrangement in Italy for OLO.

“We’ve pursued several pilots with prospective clients in Europe, specifically in the united kingdom and Italy,” said co-founder Danny Levner informs TechCrunch. “In Europe, it’s typical for market adoption to begin with pilot research: Modest clinical tests that each significant clients run at their own centers, under real-world conditions. This allows users to go through the advantages of the technologies in their context. In average progress, pilot research is then followed by modest initial orders, after which by wide deployment.”

The financing will also support continuing regulatory efforts from the U.S., where it has been conducting a series of trials as part of FDA testing in the hopes of gaining regulatory clearance for OLO.

Image courtesy: Sight Diagnostics

“In December 2018, we completed US clinical trials at three US clinical sites and we’resubmitting them later this month on the FDA. We’re seeking a 510 (k) FDA clearance for use in US CLIA compliant laboratories, to be followed by a CLIA waiver application that will allow being used at any doctor’s office. We’re quite pleased with the outcomes of the US trial and we aspire to acquire the FDA’s 510 (k) clearance within a year’s time,” he says.

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“With the current funding, we are focusing on commercialization in the European marketplace, starting in the UK, Italy, and the Nordics,” he adds.

The money will go on the r&d to expand the menu of tests the company is able to provide via OLO.

The startup previously advised it envisages developing the device into a platform capable of conducting a portfolio of blood tests, saying each additional evaluation would be added individually and only after “separate clinical investigation”.

The first test OLO provides is a complete blood count (CBC), with Sight Diagnostics employing machine learning and computer vision technologies to digitize and examine a high-resolution picture of a finger prick’s value of the patient’s blood on apparatus.

The point is to offer an alternative to getting venous blood drawn and sent away to a lab for evaluation — using an OLO-based CBC charged as taking “minutes” to perform, with the startup also asserting it is easy enough for non-professionals to carry out, whereas it says a lab-based blood count can take several days to process and return an outcome.

On the R&D front, Levner says it sees “tremendous potential” for OLO to be used to diagnose blood diseases like leukemia and sickle cell anemia.

“Also, given the small quantity of blood required and the minimally-invasive nature of the evaluation when utilizing finger-prick blood samples, there is an opportunity to use OLO in neonatal screening,” he says. “Accordingly, one of the most important immediate next steps is to tailor the test algorithms and procedures for neonate screening.”

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Levner also told us that some of its own pilot studies have looked at evaluating “improvements in patient and operator satisfaction”. “Certainly standing out in such studies is your taste for finger-prick-based testing, which OLO supplies,” he claims.

1 key point to notice: Sight Diagnostics has to release peer-reviewed results of its clinical trials. Last July it advised us it’s a novel pending in a peer-reviewed journal.

“With regards to the peer-reviewed book, we’ve decided to combine the outcomes in the Israel clinical trials together with people that we only completed in the united states to get a stronger publication,” the firm says now. “We hope to focus on that publication after we get FDA approval in the united states.”

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