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Healthcare - Biotechnology - NASDAQ - US
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$ 43.9 M
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EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2018 - Q4
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Operator

Good day and welcome to the OncoCyte conference call to discuss fourth quarter and full year 2018 financial results and operating highlights. Today's call is being recorded. At this time, I would like to turn the call over to Bob Yedid of LifeSci Advisors. Please go ahead..

Bob Yedid

Thank you, operator and thank you everyone for joining us for this afternoon's conference call to discuss OncoCyte's fourth quarter and annual 2018 financial results and recent operating highlights. If you have not seen today's financial results press releases, please visit OncoCyte's website at www.oncocyte.com.

Before turning the call over to William Annett, OncoCyte's President and Chief Executive Officer, I would like to remind you that during this conference call, the company will make projections and forward-looking statements regarding future events.

Any statements that are not historical fact, including, but not limited to statements that contain words such as will, believes, plans, expects, estimates and other similar expressions are forward-looking statements.

We encourage you to review the company's SEC filings without limitation the company's forms 10-K and 10-Q, which identify the specific risk factors that may cause actual results or events to differ materially from those described in these forward-looking statements.

These factors may include without limitation, risks inherent in the development and/or the commercialization of potential diagnostic tests, uncertainty in the results of clinical trials or regulatory approvals, the capacity of OncoCyte's third party supply blood sample analytical system, to provide consistent and precise analytic results on a commercial scale, the need to obtain third party reimbursement for patients' use of any diagnostic test the company commercializes, our need and ability to obtain future capital and maintenance of IP rights.

Therefore, our actual outcomes and results may differ materially from what is expressed or implied by these forward-looking statements. OncoCyte expressly disclaims any intent or obligation to update these forward-looking statements except as otherwise may be required under applicable law.

With that, it's my pleasure to turn the call over to Bill Annett.

Bill?.

William Annett

Thanks Bob and welcome everyone to our conference call to discuss our fourth quarter and annual 2018 financial results and operating highlights. Joining me on today's call are Al Parker, our Chief Operating Officer; Mitch Levine, Chief Financial Officer; and Lyndal Hesterberg, Senior VP of Research and Development.

We will all be available during the question-and-answer session. It's been an exciting and productive couple of months for OncoCyte. Many of you listened to our Investor call on January 29, in which we announced the game changing results from the blinded R&D validation study of our DetermaVu liquid biopsy lung cancer diagnostic test.

We followed this announcement with a successful equity raise of $40.25 million in mid-February.

These funds strengthened our balance sheet and leave us well-positioned to advance DetermaVu, while in parallel supporting a robust research and development program evaluating the utility of our immune system interrogation approach in other cancer indications. These events represent a major inflection point for our company.

Today, I want to recap these exciting developments as well to talk about our progress towards making DetermaVu commercially available in the multibillion-dollar lung cancer diagnostic market. We are still on track for achieving commercial availability around mid-year, subject to the successful completion of the development studies.

We will also review our financial results for 2018. Over the past year, we have made remarkable progress in the development of DetermaVu. We have demonstrated that DetermaVu is a best-in-class commercially viable test with the potential to fundamentally change the way that lung cancer is diagnosed.

And our scientific results have shown that DetermaVu's unique approach, which harnesses the immune system's exquisite sensitivity to the presence of cancer has potential broad applicability across other solid tumor types for early cancer diagnosis.

We are pleased to announce today that an abstract that we submitted has been accepted as a late-breaking presentation at the American Thoracic Society 2019 International Conference, which is being held May 17 to May 22 in Dallas.

The abstract entitled Blinded Prospective Validation Study of a Whole Blood Gene-Expression Classifier for the Diagnosis of Benign Versus Malignant Pulmonary Nodules describes the compelling results of our R&D validation study previously announced and is our first formal presentation of these findings.

ATS is among the largest and most highly regarded multidisciplinary medical conferences attended by over 14,000 healthcare professionals spanning a broad range of medical specialties from around the world. And we are excited to be included in the session which will explore the future of lung cancer biomarkers.

As a reminder, DetermaVu is our confirmatory noninvasive liquid biopsy test that we are developing to facilitate clinical decision-making in lung cancer diagnosis. DetermaVu is designed for use following a low dose CT scan and before undergoing a tissue biopsy in at-risk patients where their scan shows evidence of a suspicious lung nodule.

In short, DetermaVu's value proposition is to reduce the number of expensive, risky lung biopsies. I would like to now walk through the key accomplishments that have allowed us to rapidly advance the development of DetermaVu since our last quarterly update.

In January, we announced our successful transition to the Thermo Fisher Ion GeneStudio S5 next-generation sequencing platform. The implementation of this state-of-the-art sequencing platform has provided the consistent, robust, and reproducible results necessary for the continued development of DetermaVu.

The implementation also has potential benefit for commercialization and may allow for decentralized operations for the development of a CE-marked kit for a future global market expansion in Europe and other territories.

Shortly after the successful transition to the Thermo Fisher NGS platform, we announced very positive and game changing results from our R&D validation study.

The study was designed to determine the sensitivity and specificity of DetermaVu on 250 blinded patient samples utilizing the optimized mRNA biomarkers, an algorithm previously determined that accompanies algorithm development study.

Our results demonstrated sensitivity of 90% with a 95% confidence interval of 82% to 95% and specificity of 75% with a 95% confidence interval of 68% to 81%.

As a reminder, sensitivity and specificity are statistical measures of test performance with sensitivity measuring the percentage of malignant nodules that are identified correctly by the test and specificity measuring the percentage of benign nodules correctly identified.

A 95% confidence interval or CI suggests that there is a 95% chance that final test performance will be within the stated range.

Notably, these outstanding results were achieved without the use of clinical data included in the algorithm, an important accomplishment which, to our knowledge, is a first in early stage lung cancer diagnostics and will have a real world impact for physicians and payors.

Our test will provide an independent biological assessment of the risk of cancer, which is incremental to the information that clinical data alone can provide.

It's this last point that is important to doctors as they already have the clinical data for their patients and are looking for a new tool to help them in their risk stratification and decision-making.

Our results significantly exceeded the parameters we believe are required for a successful commercial product in the lung cancer diagnostics market based on an extensive market survey of chest physicians that we conducted.

I will speak more about the market opportunity for DetermaVu shortly, but first I want to provide an overview of the path towards commercialization. After completion of the R&D validation study, we initiated the analytical validation study, which is ongoing.

The goal of the analytical validation study is to establish the performance characteristics of the DetermaVu assay system. The studies required for analytical validation are established in the Clinical Laboratory Standards Institute guidelines and cover quantitation, precision, reproducibility, and interfering substances.

The analytical validation data is designed to support OncoCyte's expectations regarding DetermaVu's robust performance, as demonstrated in the R&D validation study that was completed earlier this year. While the analytical validation study is still underway, we expect it to be completed in the near future.

Upon completion, we will proceed to the remaining two studies necessary before commercialization, CLIA validation and clinical validation. Importantly, we already have in-house all of the patient blood samples required for both studies allowing DetermaVu to advance efficiently through these studies.

The R&D validation study was performed by both development and our CLIA lab staff. The analytical validation studies and the following two studies are being performed in our CLIA-certified laboratory using CLIA lab staff to demonstrate that we achieved the same results under real world CLIA lab conditions as we did in the R&D laboratory.

The next study, CLIA validation will re-run between 100 and 120 patient samples that were previously run as part of the R&D validation study to confirm that we obtained the same positive results on the analytically validated system.

Assuming successful completion of the CLIA validation study, we will then begin the final remaining step, the clinical validation study. In the clinical validation study, we will analyze approximately 350 blinded, prospectively collected patient samples for the final confirmation of test sensitivity and specificity in our CLIA lab setting.

This study is being powered to reduce the error bar of DetermaVu to about plus or minus 3% to 4%. We believe that this is the range of accuracy that will be necessary for physician confidence and adoption. We believe that we can complete these three remaining studies by mid-2019.

Assuming positive results, DetermaVu will be commercially available, proven ready for routine clinical testing at industrial scale after study completion in the second half of this year, just a few months from now. We are thrilled with our recent progress, rapidly and efficiently completing the studies necessary to bring DetermaVu to market.

I would also to highlight that our results to-date represent a true scientific breakthrough in the field of liquid biopsy for early cancer diagnosis. Our approach, which we call immune system interrogation, leverages the exquisite sensitivity of the immune system to the prevalence of early stage cancer.

Simply put, DetermaVu detects immune system gene expression changes, often a simple blood sample, to reliably and reproducibly diagnose early stage cancer. OncoCyte's unique immune-based approach was the first to succeed for early stage lung cancer diagnosis, precisely because we have taken a different approach than others.

Others in the field have tried to diagnose early stage cancer by trying to directly detect cancer DNA circulating in the blood, for example, via cell-free DNA, tumor DNA or circulating tumor cells.

While these approaches have been successful in late stage cancer where tumors are large and shed material into the bloodstream, they remain unsuccessful for early stage cancer. This is likely because in the earlier stages of cancer, there just aren't enough of these components in the blood for reliable diagnosis.

Many of our competitors have spent a lot of time, resources and money on these approaches to early stage cancer diagnosis but all have failed and DetermaVu diagnoses lung cancer at a very early stage. All of the samples in our studies are from patients with Stage 1 cancer, the earliest stage.

We believe that our immune response technology has the potential to be broadly applied across other solid tumors, with particular benefit for early stage malignancies.

Based on this, we are developing our plans for researching additional types of cancer, both scientifically and from the perspective of the relative commercial attractiveness of each market.

While our focus remains on executing on the development and commercialization of DetermaVu for lung cancer, we have begun planning for the expansion of our R&D team.

We will bring in additional talent and scientists to build our internal capabilities to advance DetermaVu while in parallel initiating additional studies to explore the application of our technology across other cancer types.

Before we turn to commercialization and reimbursement, I would like to briefly review the problem we are looking to solve with DetermaVu. Lung cancer remains the leading cause of cancer deaths in the United States and worldwide, in part because most cases are not detected until patients have late stage disease, usually Stage 3 or 4.

With approximately 234,000 new cases diagnosed and 154,000 deaths in the U.S. last year, there is significant unmet need for the early detection of lung cancer. This is where DetermaVu can help. DetermaVu is designed for use following the identification of a suspicious lung nodule after low-dose CT scan or X-ray but prior to undergoing a tissue biopsy.

It's important to note that lung biopsies are risky with high rates of complications that can in up to 1% of cases lead to death. A recent major study published in the Journal of the American Medical Association or JAMA highlighted this problem.

The study examined the outcomes from over 340,000 patients who had lung biopsies and found that there was a complication rate of 24% in Medicare patients and 22% in patients under the age of 65. This complication rate is even higher than previous estimates and emphasizes the dangers involved in lung biopsies.

In fact, for most patients, the probability of serious complications associated with biopsies are greater than the likelihood of confirming lung cancer. Moreover lung biopsies are expensive and cost an average of almost $15,000.

So a blood test that can help clinicians to determine which patients are high risk and need a biopsy has the potential to eliminate unnecessary biopsies in low risk patients, thereby avoiding complications, saving lives and leading to significant cost savings to the healthcare system.

We believe the commercial opportunity for DetermaVu is large with an estimated total addressable market of $2 billion to $4.7 billion in the U.S. alone, depending on reimbursement rate and market penetration. There are large number of patients that would benefit from our DetermaVu test.

Lung nodules are detected in one of two ways, either incidental scans or via lung specific screening programs and DetermaVu is applicable to both groups. We currently plan to launch DetermaVu independently in the U.S. with a small and targeted sales force and commercial team that we are in the process of building.

We are confident that with our current resources we can effectively promote DetermaVu to the relatively small number of chest physicians in the U.S., about 6,000 specialists that typically operate in group practices and tend to be clustered geographically.

We believe that we can start commercialization with a small number of medical science liaison professionals, supplement it as we grow with some sales reps, marketing professionals and a patient support team. We are currently finalizing our commercial plans and we will discuss these in greater detail on our upcoming conference calls.

As we make DetermaVu commercially available, we will also focus on moving forward to secure broad reimbursement from Medicare and private payors, an essential step for a successful diagnostic test.

We have already started planning a clinical utility study following commercial availability to measure how the use of DetermaVu improves health outcomes for patients and lowers costs for the healthcare system.

This real-world study will follow patients from one to two years examining the clinical outcomes and the pharmacoeconomic benefits achieved with our test. In the meantime, we are highly encouraged by the responses from 10 public and commercial health plans that we have spoken with.

They all view DetermaVu favorably, recognizing the large unmet need addressed by the test. So as I said at the beginning of this call, this is an exciting time for OncoCyte. We are well-funded. We are close to having our first product on the market.

And we have the potential to develop a pipeline of revolutionary cancer tests based on our unique technology in immune system interrogation. We believe that DetermaVu is a fundamental breakthrough in lung cancer diagnostics with the potential to dramatically improve the lung cancer treatment paradigm for patients, physicians and payors.

At this point, I would like to turn the call over to Mitch Levine for a review the financials.

Mitch?.

Mitch Levine

Thanks Bill. Good afternoon everyone. At December 31, 2018, we had $8 million of cash and cash equivalents and marketable securities valued at $428,000 for a total of $8.4 million of liquid assets.

As Bill indicated earlier, subsequent to the announcement of our very positive R&D validation study results, we raised gross proceeds of $40.25 million through an underwritten offering of common stock, which resulted in $37.4 million of net proceeds.

A good mix of new and existing investors participated in the offering, which provides us with the resources to execute our development and commercialization plans. For the fourth quarter of 2018, OncoCyte reported a net loss of $4.5 million or $0.11 per share, compared to a net loss of $4 million or $0.13 per share for the fourth quarter of 2017.

For the full year 2018, we had a net loss of $15.8 million or $0.42 per share, compared to a net loss of $19.4 million or $0.64 per share in 2017. Operating expenses for the fourth quarter of 2018 were $4 million as reported and $3.5 million on an as adjusted basis, which excludes certain non-cash operating expenses.

For the full year 2018, operating expenses were $15.2 million as reported and $12.5 million on an as adjusted basis. We have provided a reconciliation between GAAP and non-GAAP operating expenses in the financial tables included with our earnings release, which we believe is helpful in understanding our ongoing operating expenses.

Cash used in operations was $2.5 million for the fourth quarter of 2018 or approximately $800,000 per month, which compares to cash used in operations of $3.3 million during the fourth quarter of 2017. Research and development expenses for the fourth quarter of 2018 were $1.2 million compared to $1.5 million for the same period in 2017.

For the full year 2018, R&D expenses were $6.5 million compared to $7.2 million in 2017. General and administrative expenses for the fourth quarter were $2.6 million, compared to $1.8 million for the same period in 2017. For the full year 2018, G&A expenses were $7 million, as compared to $9.2 million in 2017.

Sales and marketing expenses for the fourth quarter were $300,000 compared to $600,000 for the comparable period in 2017, while for the full year 2018 they were $1.7 million, as compared to $2.4 million in 2017. That concludes my remarks concerning our financial results and now we will open the call to your questions..

Operator

[Operator Instructions]. Our first question comes from Bill Quirk, Piper Jaffray. Please proceed with your question..

Bill Quirk

Great. Thanks. Good afternoon everyone..

William Annett

Hi Bill..

Mitch Levine

Hi Bill..

Bill Quirk

So first question, I guess, if we think about preparing the commercial launch, can you just remind us kind of where you are in terms CLIA certification? And I am thinking specifically around the states of California and New York, whether or not you are certified there already in the process or you will be starting that process soon?.

William Annett

Right. So we do have CLIA certification in the state of California and given reciprocity from other states as well as some states which we have applied for and received, we have certification in 49 states.

State of New York is still outstanding, and we will begin the process of applying for certification in New York probably once we make DetermaVu commercially available..

Bill Quirk

Okay. Got it. And then maybe a couple for Mitch. Thanks, obviously, for the details of the 2018 P&L. Given the comments with respect to that Bill made regarding adding some staff on the sales side as well as in R&D, how should we think about OpEx trending here in 2019? And then also what should we be thinking about in terms of cash usage? Thank you..

Mitch Levine

Thanks Bill. We haven't publicly disclosed our anticipated cost, but we have developed an efficient and focused commercialization plan. So we are going to grow modestly as we get to milestones with regard to peer-reviewed papers, et cetera. Probably put in place a handful of people on the commercial side early on.

So I would anticipate a modest ramp in our burn, but not dramatically..

Bill Quirk

Okay. Perfect.

And then with respect to the late-breaking abstract that was accepted relative to the R&D validation study, anything new in there that we should be looking beyond what you released earlier this year?.

William Annett

Yes.

Lyndal, can you address that?.

Lyndal Hesterberg

Sure. I would be glad to. There is a new piece of information that's there to look specifically within 0.8 to three centimeter nodules which are considered LungRADS 4.

Compare the performance of DetermaVu product to the most widely available clinical models and this is a male model that simply uses clinical facts to help the physicians assess the risk that the person [indiscernible] who has cancer.

And the area under the curve or the DetermaVu was significantly higher statistically than that for the clinical model itself. So we are very pleased that this confirms the value to biology risk assessment that we are providing..

Bill Quirk

Got it. Okay. Thank you much guys. .

William Annett

Thanks Bill..

Mitch Levine

Thanks Bill..

Operator

Our next question comes from Paul Knight, Janney Montgomery Scott. Please proceed with your question..

Paul Knight

Hi Bill. Hi Mitch. Hi Lyndal..

William Annett

Hi Paul..

Mitch Levine

Very good. Thanks Paul..

Paul Knight

Could you talk, you said what, you were in discussions with 11 commercial reimbursement organizations and what's been the feedback?.

William Annett

Yes. We have talked with the medical directors in those groups. And I think they covered something like 77 million lives in the U.S., so pretty good chunk of the U.S. population.

And we basically spent an hour or so with each medical director, took them through DetermaVu results so far, the clinical protocols that we are following and so on and got their view about things.

And I think that there was unanimity among them that first off that there is a major issue that they see in terms of the unnecessary biopsies and the complications and deaths and cost coming out of them. They all see the same thing which we do.

They also believe that DetermaVu could be, if our upcoming studies bear out and give the kind of results that we have seen to-date, they all agreed that DetermaVu could be an important part of the solution to that problem.

And then finally, when we asked them about reimbursement, they said, well, you know, you have to go through the process, of course, as everybody does, but that if we do get the kinds of results that we have seen to-date and using the clinical protocols that we talked about that certainly they would consider our applications favorably..

Paul Knight

Do you think they are looking at LungRADS 4 market or do you think they are thinking earlier? I guess the question is, are these biopsies occurring at LungRADS 3 often enough or even earlier that they have in mind something besides LungRADS 4? Or is it a LungRADS 4, in their view?.

William Annett

I think there is a mixed view on that. LungRADS 4, of course, is the eight to 30 millimeter nodules. I think that's the first indication, the low-hanging fruit because today, of course most, if not all of the nodules in that size are going for biopsy. So clearly there is a clear need in LungRADS 4.

LungRADS 3, which is the five to eight millimeter nodules today, well guidelines indicate watch and wait, do more frequent low-dose CT scan every three to six months. According to papers that we have seen, probably 20% to 25% of LungRADS 3 nodules are getting biopsy today.

So as a result, there is clearly some need today and I think that the payors would want to see for LungRADS 3, they would want to see the results of the clinical utility study which we plan on doing after launch to show kind of the long-term economic benefit.

So I would say, sort of high level summary, I would say LungRADS 4 has lot of interest, clearly needed there, LungRADS 3 is to be determined based on what clinical utility study says..

Paul Knight

And I guess lastly, Bill, would you say that physician practice is your biggest obstacle or commercial reimbursement?.

William Annett

I don't think physician practice is a major barrier. We have talked with over 200 chest physicians and key opinion leaders and so on. They are all very aware of this diagnostic dilemma of knowing that the vast majority of biopsies will end up benign and therefore not necessary, but not knowing which is which. So the physicians are aware of the problem.

They are very concerned about it. And I think that's one of the reasons why we were included as a late-breaking presentation, poster presentation at ATS, as it is an area of a lot of discussion. So we do believe there will be a lot of interest from physicians. Reimbursement, like every other diagnostic company, it does take time.

We will work with the Medicare, CMS to get reimbursement from the public payors as well as the various private payors as well. And so, like everyone else in the diagnostic industry, that can take some time..

Paul Knight

Okay.

And then can you just lastly talk to CMS process that you plan on?.

William Annett

Right.

Well, again the CMS, the payors from Medicare and Medicaid have an established process, which is well laid out and basically what you have to do is put together a dossier of information, including your results, the clinical protocols, the clinical results and you have to have at least one published paper in a peer-reviewed journal and we are planning on applying to peer-review journal with the results coming out of the R&D validation study and the clinical validation study.

So once we get that journal article published, we will submit the dossier to Medicare and Medicare then goes through a standard process and it takes, we are told, on average these days six to nine months, sometimes more for them to come to their conclusions in a favorable positively.

They give, what's called a local coverage decision, which means that Medicare patients throughout the country can be covered at the price which Medicare determines. So that's at a very high level, the process that one goes through to get the Medicare coverage. Private payor coverage, of course, is done on an individual basis.

Each different private organization has their own standards and their own time line..

Paul Knight

Thank you..

William Annett

Thanks Paul..

Operator

Our next question comes from Bruce Jackson, The Benchmark Company. Please proceed with your question..

Bruce Jackson

Hi. Thank you. So when you do get down to the clinical validation study, how fast you think you are going to be able to accrue the samples? You have already been working with a he number of institutions, I think.

So if you could just tell us how many site you have got set up and how fast you think you can get that particular study completed?.

William Annett

Yes. So we have all of the samples that are needed now for both CLIA validation and clinical validation. They are all in the freezer at the moment. And in total, we collected samples from about 66 sites across the U.S. And so as a result, we have got everything that we need in terms of samples..

Bruce Jackson

Okay. And then with the burn rate and the operating expense profile, so you are going to probably be hiring a few people this year.

Should we expect some kind of a ramp up in the operating expenses?.

William Annett

Sure. Bruce, I think it will be a very modest ramp from what we have shown in the past. As I said, we are going to bring in a handful, a small handful, three to five commercial salespeople, a couple medical science liaisons.

And over time, as we get closer to reimbursement and once we have reimbursement, you know there is only maybe 6,000 pulmonologists in the United States.

So even at full ramp, we expect to have maybe 40 outside salespeople as opposed to a great some of the companies out there might have 400 or 500 outside salespeople because they are calling on primary care physicians. Our market is much, much smaller with only about 6,000 pulmonologists. So I would expect a very modest ramp..

Bruce Jackson

Okay. That's great. Thanks very much..

William Annett

Thanks Bruce..

Operator

[Operator Instructions]. Our next question comes from Bill Quirk, Piper Jaffray. Please proceed with your question..

Bill Quirk

Hi. Just a follow-up. So looking at the abstract a little closer, maybe you can kind of delve into the fact that in the original R&D validation study, which is lesions five to 30 millimeters, the AUC was 0.89.

And then when we shift that into a study of high-risk population, meaning that eight to 30, the AUC actually went down a couple of points to 0.87. So I am just trying to, maybe you can help sort that through with us a little bit. Obviously it implies very good things for the data in the LungRADS 3 population.

But I am just curious why this signal would drop off a little bit in a higher risk population? Thanks..

William Annett

Lyndal, can you address that?.

Lyndal Hesterberg

Sure. I would be glad to. So first, the small drop-off of two percentage points is statistically insignificant given the number of samples that we are working with. It falls well within the plus or minus 8% error mark. So the biostatisticians tell us the numbers are statistically indistinguishable.

To answer your question, that's just due to the fact of the specific number of samples that happen to fall within this range of the LungRADS 4, which are the clinically very challenging samples for physicians to diagnose..

Bill Quirk

Got it. Thank you very much..

Operator

Our next question comes from Keay Nakae, Chardan Capital Markets. Please proceed with your question..

Keay Nakae

Hi. Yes. Thanks. Bill, a question about potential reimbursement while you are connecting the clinical utility program.

There is something available for that under, like the Palmetto CDD program?.

William Annett

Yes. There is. They changed the name again. They don't call it CDD anymore. It used to be known as coverage with data development. In essence, as we understand it, the same program is in place, although they don't call it that.

When Paul Knight asked the question about the CMS reimbursement process, that process is going on in parallel to our clinical utility study. To just give you a sense of the timing there, we will start clinical utility probably around the same time that we submit the Medicare dossier.

And the reason for that is, we don't want to start clinical utility until you have a paper or papers published in peer-reviewed journals because you want something to be able to show the doctors that say, look, here is independent confirmation. And so as a reminder, the clinical utility study is a real-world evidence study.

That means it's following real patients, real doctors. We are using the test in the world. It will be a double-armed study. The patients in both arms will have our test, DetermaVu. The doctors in one arm will be blinded to the results and the doctors and the other arm will see the results of the test.

And then at the end of one to two years, you compare the two arms and see what are the clinical outcomes, are there fewer biopsies, fewer complications and so on and what are the healthcare economic benefits, is one arm less expensive than the other.

And you compare those and you make that information available to Medicare, the private payors and so on. So that clinical utility study, as I said, will take a year or two to complete after enrollment.

But in parallel, the CMS reimbursement process which I outlined previously is going on and we should get, again if the timeline and the steps are the same for us as has been characteristic of the companies in the past, we should get CMS coverage well before of clinical utility is completed. So that's kind of how the two interface..

Keay Nakae

Okay. Well, thanks..

Operator

We have reached the end of the question-and-answer session. I will now turn the call over to William Annett for closing remarks..

William Annett

Well, thanks everyone again for joining our call this afternoon. We do hope that you are as excited as we are about OncoCyte's progress and our upcoming milestones. We are well-funded. We have an exciting potential pipeline of liquid biopsy tests.

And of course, we are moving forward with significant momentum in the development of DetermaVu and in a few months plan to have it commercially available in a potentially multibillion-dollar lung cancer diagnostic test market. We are looking forward to providing you with further updates in the coming months. Thank you..

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation..

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