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New Day Diagnostics Aims to Enter CRC Screening Market With Combined PCR, Immunoassay Test


NEW YORK – With technologies brought under one roof through a pair of deals last summer, New Day Diagnostics aims to complete within the next two years the development of a blood-based screening test utilizing protein and genetic biomarkers for colorectal cancer.

Last July, New Day Diagnostics and EDP Biotech announced they were merging under the New Day name. EDP had developed prior to the deal a multiplex immunoassay, ColoPlex, for the early detection of colorectal cancer and precancerous polyps.

Later that month, New Day said it had also reached a deal to acquire the patents and biobank of Berlin-based molecular testing firm Epigenomics, which already had been developing a next-generation version of its PCR-based Epi ProColon screening test for the detection of DNA methylation biomarkers.

New Day CEO Eric Mayer recently said that since the two deals, the Knoxville, Tennessee-based firm has been developing a platform-agnostic test, dubbed ColoPlex Plus, which will be run on PCR and immunoassay instruments to detect both protein and genetic biomarkers to aid in the diagnosis of colorectal cancer. He expects that clinical trials aimed at getting US Food and Drug Administration approval for the test can be completed within the next 24 months.

Mayer said that the molecular biomarkers are mSEPT9, which was targeted by the previous Epi ProColon test, and one other methylated DNA marker that he is not ready to disclose. The immunoassay component is used to target L1CAM, CEA, GDF15, and several proprietary protein markers, he said.

He noted that the company's early feasibility study results indicate that the test's accuracy was at least on par with published liquid biopsy-based test results but said that the test has shined so far in the detection of cancer, polyps, and adenomas. Mayer cautioned that those promising signs came from preliminary results, however, and the firm was planning two concurrent trials that will be used to evaluate the test's performance.

He described one of those studies as a continuation of a pivotal trial that Epigenomics had started prior to the acquisition by New Day. Epigenomics announced in September 2022 that it expected to enroll more than 15,000 patients in a prospective, multicenter clinical trial, dubbed CRC-Detection Reliable Assessment With Blood (CRC-DRAW), which would be used to support a premarket approval submission to the FDA.

In December 2022, Epigenomics officials said the firm's next-generation assay for the detection of colorectal cancer had achieved 84 percent sensitivity and 90 percent specificity and an advanced adenoma detection rate of 20 percent in preclinical testing of 241 patients. However, the firm announced in February 2023 that it had been unable to secure funding necessary to conduct the study to support its next-generation test.

The firm also said at the time that it would undergo a restructuring that would include a recall of its Epi ProColon tests, as well as layoffs and a reduction of remaining operations. Mayer said New Day has been working with partners and the FDA on resuming the trial begun by Epigenomics.

He said that New Day is also planning a parallel study that will assess the test's performance using samples that Epigenomics and New Day Diagnostics had used in prior studies to support both companies' colorectal cancer test development.

New Day believes blood-based testing could potentially help increase patient compliance with colon cancer screening guidance by offering an alternative to conventional options, such as colonoscopy or fecal immunochemical testing. Collecting samples through a blood draw is a more attractive screening option for those who don't want to take time off work for a colonoscopy or are squeamish about stool sample collection, according to Mayer, who added that ColoPlex Plus is designed for use with confirmatory colonoscopy, though, if the test result is positive.

Mayer said the company is aiming for a price tag below $200 for ColoPlex Plus.

Mayer said that the early test results also indicate that the test will clear the threshold set by the US Centers for Medicare and Medicaid Services for reimbursement. The company has also developed strategies for publishing peer-reviewed data as studies are completed and is working with key opinion leaders and physicians to establish a market for the test, in addition to marketing the test to physicians and patients.

ColoPlex Plus is only one of several blood-based tests for colorectal cancer that are in development or poised to enter the market. Guardant Health has been developing its own blood-based test, and study results published last month found that its test was particularly effective at finding early-stage CRCs. Freenome also recently published preliminary data from its pivotal trial PREEMPT CRC for the blood-based detection of colorectal cancers.

Also, Exact Sciences said in February that it had applied to the FDA for premarket approval of a second-generation of its stool-based Cologuard cancer screening test, and the company plans to announce this year top-line results from research on a blood-based colon cancer screening test that the company has developed as a second-line screening option for patients who refuse Cologuard and colonoscopy.

While New Day is developing its ColoPlex Plus test, it has also restarted sales of Epigenomics' Epi ProColon test, which New Day has renamed ColoHealth. Mayer said that New Day began selling it in late March as a laboratory-developed test, and he expects that New Day will be able to sell ColoHealth as a kitted test in the US as early as this summer, pending FDA review of the firm's application to transfer approval of the test to New Day.

For now, New Day is selling ColoHealth by prescription for $199 as a self-paid test while the firm tries to secure reimbursement from commercial payors.

As it does so, New Day will have to overcome a checkered history for the Epi ProColon test. Epigenomics tried for years to establish the test in the US market. Following an adverse decision in 2014, the firm finally received approval in 2016 only to spend the months that followed defending the test's efficacy against a critical report from the US Preventive Services Task Force.

The firm struggled to gain adoption of the test and secure a reimbursement rate that reflected the cost and labor to perform the test, and in 2021, the CMS denied coverage of the Epi ProColon assay for Medicare-eligible patients. CMS officials wrote at the time that tests must have at least 74 percent sensitivity and 90 percent specificity in the detection of colorectal cancer compared to colonoscopy and that Epi ProColon did not meet those criteria.

By March 2022, the firm reported that it was no longer actively marketing Epi ProColon, and it had focused its attention on the development of the next generation version of the test.

Mayer said that Epigenomics had focused on selling its kitted Epi ProColon tests and licensed technologies through major clinical lab companies such as Laboratory Corporation of America and Quest Diagnostics, which made the CMS decision difficult to overcome. New Day is marketing the test as ColoHealth through a consumer-focused "ask your doctor"-type of campaign, and he expects that a sizeable patient population would rather pay $199 out of pocket than undertake a colonoscopy or collect a fecal sample for a test that is covered by insurance.

Mayer also said that he is confident in the assay's performance, especially its negative predictive value.

Epigenomics had said in marketing materials published in 2017 that Epi ProColon performed in two clinical trials with negative predictive values of 99.7 percent and 99.8 percent. The first trial compared the accuracy of Epi ProColon to colonoscopy in 1,544 patient samples, and the test performed with sensitivity of 68.2 percent and specificity of 80.0 percent. A second trial compared the accuracy of Epi ProColon to a fecal immunochemical test using matched blood and stool samples from 290 patients, and the results indicated the test performed with sensitivity of 72.2 percent and specificity of 80.8 percent.

While Mayer said that some physicians may have hesitations about those sensitivity and specificity numbers, he thinks patients are more interested in the peace of mind offered by a negative result. He added that about 60 percent of patients with positive results also have actionable findings.

As for ColoPlex Plus, Mayer said the company will pursue simultaneous strategies of similar direct-to-consumer marketing as well as reimbursement from payors, which he expects the company will achieve because of the accuracy of the test in studies so far.

The firm also has been in talks with potential partners outside the US, although Mayer said he is not ready to reveal details of those partnerships.