4 Start-Ups Disrupting Blood-Based Diagnostics.

Start-ups are what makes the diagnostics space so special.

They never stand still. They’re constantly discovering new technologies and uncovering new ways to test. And in turn, this drives the rest of the diagnostics space to keep pushing boundaries and provide better support for healthcare.

What makes these companies so disruptive is the innovative people at the heart of their businesses who’re striving to make a difference in the world.

In this article, I’d like to celebrate these hard-working people by acknowledging the technologies behind four of the most innovative start-ups disrupting blood-based diagnostics right now.

Sight Diagnostics 

We start in Tel Aviv, Israel, at the headquarters of Sight Diagnostics.

This innovative start-up is spearheading the democratisation of fast, accurate and convenient blood diagnostics through its flagship Complete-Blood-Count (CBC) analyser, Sight OLO.

Every year, it’s estimated that four billion CBC tests are ordered worldwide to offer insights into patients with undiagnosed fevers and low energy or just for routine check-ups. This is because CBC is incredibly effective at narrowing down a patient’s possible diagnosis.

While this is great, traditional CBC testing is a slow and costly process which requires trained lab professionals to evaluate samples with large and outdated equipment. This means that patients sometimes have to wait days for results.

However, Sight is changing the CBC game. With two drops of blood from a finger prick or venous sample, OLO provides results in minutes. The OLO is compact (think about the size of your toaster) and is so easy to use that even non-healthcare providers can run tests.

I spoke to Judy Boniface-Chang, Vice President of Marketing at Sight to further understand this innovative technology.

If you take oncology patients as an example, they need to get a CBC test before each chemo treatment to monitor their white blood cell count. With OLO, the same healthcare worker can draw the blood, run the test and analyse the results within minutes. So, it’s a more efficient workflow and a better patient experience.

In a similar vein, paediatricians can use OLO to diagnose and provide next steps for kids during the same visit, rather than requiring parents to come back the next day.

OLO leverages a patented method of digitising blood samples and is built with high-powered microscopes, computer vision and artificial intelligence (AI) to read out 19 different parameters of blood.

This is the highest-grade CBC test available, comparable to the gold standard equipment used in labs. But unlike expensive and cumbersome lab equipment, OLO can be easily integrated into any clinical setting, runs off a standard power outlet and only requires a credit card-sized cartridge to run samples.

The cartridges are disposable too, meaning they don’t require liquid reagents or device washouts.  This makes the device low maintenance and saves operators’ overhead time.

There’s no doubt that Sight has exciting times ahead, thanks to its innovative technology, some impressive financial backing and ambitious growth plans.

Last year we secured $71 million in Series D funding. So, throughout 2021 we plan to use this backing to expand our internal team, install OLO globally and continue investing in R&D.

For example, we’re currently focused on building internal capacity across the entire organisation from manufacturing to commercial functions. Late last year, we opened an office in New York City, which we are continuing to grow as we deploy our tech across the US. Then globally, we also recently installed OLO in the UAE and Canada - and expanded our commercial footprint in LATAM and Europe too.

In terms of R&D, with the half a petabyte of clinical image data we’ve gathered from our blood imagery, we’re further developing and improving our AI engine to design new tests for an array of other health conditions.

Truvian Sciences 

Californian start-up, Truvian Sciences, has an equally exciting future.

Like Sight, the company is on a mission to disrupt the blood diagnostics industry. To do this, Truvian is developing an easy-to-use automated benchtop blood testing system that provides lab-accurate results for a comprehensive suite of routine health tests – all in a single run. These results are available within in 20 minutes.

Powered by patented technologies and intelligent integration, Truvian’s compact instrument will deliver a convenient and affordable alternative to offsite laboratories. The ground-breaking diagnostic platform combines clinical chemistry, immunoassay and hematology simultaneously within one instrument.

The instrument will make diagnosis processes much easier and quicker for healthcare professionals, with its wellness panel covering the most ordered tests including:

• Complete blood count (CBC) with three-part differential
• Comprehensive metabolic panel
• Lipid panel
• Hemoglobin A1c and glucose
• Liver function test
• Kidney function test
• Thyroid screening test

Truvian has now raised more than $105m in series C funding to finance for the final steps of this technology’s development. This cash injection will also help scale up the company’s commercialisation teams in preparation for launch, alongside several new appointments to its C-suite and board of directors.

Visby Medical

LikeTruvian and Sight, Visby Medical is set to revolutionise the blood diagnostics space but in infectious disease diagnostics instead.

To get further insight into the exciting Californian start-up, I spoke to Shari Kipp, Senior Director of Global Marketing at Visby. She explained what it means to be working at this pioneering company.

We are driven by a belief that disease diagnosis should be quick, accurate and accessible to all.  We are on a mission to empower anyone to test for any infection, anywhere, with near real-time results and near 100% accuracy, to help the clinician and the patient.

To achieve this, Visby has developed a novel instrument-free polymerase chain reaction (PCR) platform that aims to redefine the way an infectious disease is diagnosed and treated.

By shrinking PCR technology to palm-sized dimensions and eliminating the need for an additional instrument or reader, Visby Medical’s PCR platform provides fast, accurate and actionable results at the point of need.

This enables fast data-driven diagnosis and accurate treatment all while the patient is present. This is critical to empower clinicians to accurately diagnose, improve patient outcomes, reduce patient anxiety and reduce spread of infectious disease within the community. 

In most areas of medicine, doctors can access data or test results before making their clinical diagnosis and treatment decisions. But with infectious disease they have to act fast, so doctors are often fighting blind. They’re forced to make treatment decisions without accurate test results on-hand or use tests that sacrifice accuracy for speed.

That’s no longer the case with the Visby Medical device. Our PCR platform can match the performance of the lab PCR without the instrument investment or commitment, with results in under 30 minutes. So, doctors can make informed decisions, quickly, while the patient is present.

Like many infectious disease companies, Visby leveraged its platform to provide support for the global pandemic. In July 2020, it developed a functional COVID-19 test which received Emergency Use Authorization in September.

Visby is rapidly expanding access to its single-use, rapid PCR test for use at the point of care (POC). But in the meanwhile, the start-up is also preparing to commercialise its women's health sexually transmitted disease multiplex test for chlamydia, gonorrhoeae and trichomonas vaginitis, once FDA clearance is received.

Karius

Like Visby, Karius is also on a mission to improve infectious disease diagnostics.

Its Karius Test is a blood test based on next-generation sequencing of microbial cell-free DNA. This can identify and quantify over 1,000 clinically relevant pathogens including bacteria, DNA viruses, fungi and parasites. Its applications include complicated pneumonia, infections in immunocompromised patients and endocarditis.

The Karius Test offers comprehensive pathogen detection of over 1,000 bacteria, DNA viruses, fungi, molds and eukaryotes. By detecting pathogens, Karius claims its test demonstrates superior yield when compared to blood culture and other microbiological testing. The company also say that the Karius Test can identify etiologies of infections more rapidly than the standard-of-care diagnostic workup.

There’s a lot of excitement surrounding this novel technology, reflected by a $165 million round of Series B funding in 2020. This has helped Karius expand access to its proprietary microbial cell-free DNA technology to help doctors diagnose infectious diseases, broaden clinical development and accelerate technology innovation.

Start-ups like Karius, Visby, Truvian and Sight are the beating heart of the blood-based diagnostics space. Their innovations are empowering other companies in their relative niches to keep discovering new technologies and uncovering new ways to test.

With so many more start-ups emerging throughout diagnostics globally, it’s a privilege to be a part of this industry and to support these emerging companies with my contacts and recruitment services.

If you’d like to learn more about these companies or would like to discuss the diagnostics space further, please get in touch. My email is Nathan.Rigby@lifesci-cm.com.

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