IVD Companies to Watch Out for in the US.

There are few industries that have enjoyed growth like the IVD market in the last 20 years. It’s now worth $69bn annually.

The North American market makes up almost half of this ($31bn) and the US remains the largest single-country market in the world.

While the growth rate is expected to slow in the states, there are certain areas investors are getting excited about. These include next-generation sequencing (NGS), cancer testing and companion diagnostic technologies. 

Working exclusively in the IVD talent market, I’m constantly coming across new companies in these areas – both big and small. Here are five companies you need to watch out for in the US...

Let’s start with a new name, but by no means a new player.

OncoCell MDx are now called Immunis AI. The company claim this change of identity is to reflect the expanded potential of their technology and a new stage in their growth.

Immunis AI’s liquid biopsy test, Intelligentia, focuses on the early detection of cancer and other diseases at the point of immune-escape - when there’s the best opportunity for cure.

Their patented Intelligentia platform harnesses the power of an immune defense system, RNAseq technology and machine learning for the development of disease-specific algorithms.

Plans to take this novel platform to market were supported in September 2019 with a $22.2m series B financing round. This funding will also support their plans to launch the first noninvasive diagnostic test for early prostate cancer detection in 2020.

San Diego-based Truvian Sciences have also enjoyed a lucrative funding round.

They’ve raised $27.1m to support the development of their automated benchtop system. This platform produces lab-accurate results for a range of health tests using a 7ml sample of blood. It is designed to deliver results in 20 minutes and could costs just $50 per test. That’s compared to competitor tests which can cost several thousands of dollars.

According to their CEO, Jeff Hawkins, they are currently working towards a CE mark and a submission to the FDA. They’re on track to achieve both in the second half of 2020. If all goes to plan, expect this to be a game changer in the IVD market and take-off in the US.

As a former VP and GM of Illumina, Jeff’s experience and leadership will be crucial within the commercialization process. It won’t be all up to him though. He’s supported by a wealth of leading life science executives including the former co-founder of Epic Sciences, Dena Marrinucc (SVP), another former executive at Epic Sciences, Katherine Atkinson, and Paul Meister who was a Chairman of the Board at Thermo Fisher.

ArcherDx are another start-up catching people’s eye. They burst into 2020 winning breakthrough device designation from the FDA for their personalized cancer monitoring (PCM) technology.

This followed the breakthrough nod they received from the FDA for their Stratafide pan-solid tumor device. This is designed to employ genomic sequencing testing to accept tissue and blood that can be used in hospitals or regional reference laboratories.

They’re backed by serious funding too. In September 2019, they raised $60m to help scale operations and advance their companion diagnostics program, which includes solid tumors, hematological malignancies and circulating tumor DNA applications. This will also help them expand their minimal residual disease (MRD) monitoring program.

With strong financial backing and two exciting products awaiting FDA approval, ArcherDx have every reason to feel ambitious about their future.

Ambition in IVD has been exemplified by bigger US corporations too. In one of the biggest IVD deals of 2019, Exact Sciences acquired Genomics Health for $2.8bn.

While Exact Science’s Cologuard - the first stool DNA test for colorectal cancer - has been gaining in popularity in the US, the company are yet to be profitable. In contrast, Genomic Health have - they reported revenue of $114.1m for Q2 of 2019.

This deal has expanded Exact Sciences’ market coverage from cancer screening to cancer diagnostics, monitoring and disease management. It has also provided them with access to Genomic Health’s oncology salesforce and an international presence in over 90 countries.

In addition to these commercial benefits, it has resulted in an extensive R&D team that Exact Sciences plan to leverage to develop innovative new cancer diagnostic products.

Uniting these two strong brands in cancer IVD devices means that Exact Sciences now have the potential to dominate the US market, as well as the global one.

However, let’s be cautious. There are still concerns surrounding the lack of commercial synergies between the companies. For example, Exact Sciences’ Cologuard product is mainly targeted at primary care physicians, whereas Genomic Health’s Oncotype DX devices are targeted at oncologists, surgeons, pathologists and urologists.

I’m eager to see how this unfolds.

While these four US-born companies are making noise in the states, it’s important to consider a European powerhouse that’s having more than enough success on US-soil.

Biocartis have continued to innovate in molecular diagnostics and develop their popular Idylla platform. They’ve enjoyed expansion of their installed instruments base, with the US market representing 40% of all new Idylla instrument placements.

In October 2019, they launched their Idylla Mutation Assay (liquid biopsy). This can detect 49 mutations from 2ml of blood plasma and provide results in just 160 minutes. This device has already caused a lot of excitement throughout the US.

Biocartis are now expecting US market clearance for their Idylla MSI Test for colorectal cancer via 510(k), as well as a PMA application for their Idylla RAS tests and expecting to launch their GeneFusion Panel for lung cancer.

If they continue to increase instrument sales, it could be exciting times ahead for Biocartis as they strengthen their position in the US market.

North America is a hot bed of innovation and activity for an already vastly growing IVD market. While I’ve highlighted these as five companies, big and small, to take the market by storm; there’s plenty more out there to get excited about.

If you'd like to learn more about these companies or share your thoughts on the IVD space, please email me at Paul.Atkinson@lifesci-cm.com.

You can learn more about my recruitment services and see more of my content on my consultant page.