Oncocyte Reports It's Ready To Enter The $3.6 Billion Transplant Diagnostics Market In First Half Of 2022

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The transplant diagnostics market encompasses blood tests, genetic sequencing, and other technology to monitor transplant patients and predict complications to make sure their bodies don’t reject new organs or tissue. 

The market was estimated at $3.6 billion in 2019 and is projected to reach $5.5 billion by 2025 as access to lifesaving transplant procedures increases and faster, less complicated, diagnostic tools are developed. 

Oncocyte Corp. OCX, a company focused primarily on the immune therapy diagnostics market, is setting its sights on the rapidly growing transplant diagnostics market after its acquisition of Chronix Biomedical early last year. The acquisition added new intellectual property (IP) and technology - the TheraSure™ Transplant Monitor - that has allowed the company to develop its own portfolio of patented transplant-rejection tests. 

A Need For Faster, Earlier Detection Of Transplant Rejection?

On any given day in the United States, 75,000 people are on waiting lists for organs. Deceased organ donors provide about 28,000 organs each year while living donors add another 6,000, but that still means more than half of those patients on the waiting list won’t get the organ they need within the year. 

Complicating the issue further is the fact that 10% to 20% of transplants are rejected by the patient’s body — a problem that can cause the new organ to fail if not caught early enough because the immune system will begin aggressively attacking the foreign tissue.

With a transplant-rejection test, doctors can regularly monitor a transplant patient to watch for warning signs of rejection. When detected early, doctors have an opportunity to intervene with anti-rejection therapies that can potentially stop the rejection process and reverse the damage caused.

To do that, healthcare providers have traditionally relied on biopsies, an invasive procedure in which a piece of tissue from the transplanted organ is surgically removed to test for signs of rejection. While the results of these tests are accurate, biopsies are invasive and painful. And doctors need to test patients repeatedly over the course of the first year — and sometimes longer when there’s a risk of chronic rejection.

Researchers have been looking for a safer, less painful alternative. That alternative came with the development of the donor-derived cell-free DNA (ddcf-DNA) test. 

A National Institute of Health (NIH) study published last month found that from a simple blood sample, the test was able to detect rejection as early as 28 days after transplant — at least three months earlier than a standard biopsy would detect warning signs.

The same study concluded that the novel blood test could eliminate as much as 80% of biopsies currently used to detect transplant rejection.

There are other tests like this that are currently being marketed that offer similar negative predictive value rates for kidney, heart, and lung transplant candidates and are covered by Medicare, but it can take three or four days to get results, and there is a market need for faster turnaround time of patient results.

Meanwhile, the TheraSure Transplant Monitor covers kidney and heart transplants and is one of the only two dd-cfDNA tests currently validated for liver transplants, of which there are 8,000 per year in the US alone. The test is performed in digital PCR, a different technology than the current market players (Next Generation Sequencing) allowing an expected faster turnaround time by up to 4 days, which is important for patient convenience. Therasure is also the only technology that has the potential to accurately provide absolute quantification of the amount of dd cfDNA is in a blood sample which could allow for it to be used for years to monitor potential rejection.

Oncocyte’s New Path To Market

With initial plans for launching a Lab Developed Test in the patented digital polymerase chain reaction (PCR) format in Europe and the US in the first half of 2022 to drive near term revenue, Oncoctye announced it would pivot to develop a kitted version in combination with a digital PCR platform provider in the second half of 2022 with the ultimate goal of putting this game changing test in the hands of Transplant Centers via an FDA Cleared kit sometime in late 2023. 

The company plans for the dual strategy to allow it to break into the U.S. market sooner because the Centers for Medicare & Medicaid Services (CMS) issued a local coverage determination (LCD) last April stating it would cover any transplant rejection LDTs that are the same or comparable to those already covered by Medicare and Medicaid. 

For Oncocyte, that means the path to the market is anticipated to be shorter than it would be for its IVD test, which still must go through a full clinical program with the Food and Drug Administration (FDA). The respective clinical trials are planned for early 2023, but the company’s LDT could potentially hit the market long before they begin as long as the CMS review of the existing data Oncocyte has gathered confirms that the test qualifies for coverage.

This post contains sponsored advertising content. This content is for informational purposes only and is not intended to be investing advice. The TheraSure Transplant Monitor has not been cleared or approved by the US Food and Drug Administration. 

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