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CanHelp Pushes Gene Expression Tests Toward Clinical Approval in China

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NEW YORK (GenomeWeb) – CanHelp, a recently formed Chinese diagnostics company, is pushing forward with plans to commercialize a variety of gene expression tests for the subtyping or differentiation of various cancers.

The company said in an email today that it has validated three PCR-based tests — one for cancers of unknown primary (CUP), one for lung cancer, and one for renal cancer — and is now in the process of seeking China Food and Drug Administration approval for them. The firm also has plans for at least two other assays in the works.

All three of the current tests are designed to run on qPCR instruments from Thermo Fisher Scientific, which CanHelp's CEO Qinghua Xu said offer sensitivity, cost, and ease-of-use advantages that make sense in the Chinese market.

CanHelp announced last November that it had entered into a global supply agreement with Thermo to employ the company's real-time PCR system in its CUP test. In his email this week, Xu said that the same system is also being used for the other two assays.

The company's first test, for which it has begun the process of CFDA approval, is an assay for CUP. Called PanCA, it is designed to discern the biological origin of metastatic cancers with no obvious primary source in the body.

Several companies have already targeted the subtyping of CUP both within the US and without. Belgium-based OncoDNA offers a test called OncoDeep CUP, which combines next-generation sequencing and immunohistochemistry assays to determine the point of origin of a cancer and to provide data that can be used to select treatments.

In the US, BioTheranostics markets a CUP test called CancerType ID, which, like CanHelp's, uses real-time PCR to assay the expression of 92 genes. Rosetta Genomics also offers a microRNA-based Cancer Origin Test, and Cancer Genetics sells the only US Food and Drug Administration-approved CUP assay, the Tissue of Origin test originally developed by Pathwork Diagnostics.

Xu said in an email that for its part, CanHelp believes it is the first to advance a qRT-PCR assay for CUP in China, and thus hopes to be able to capture a significant share of the market in that country.

"We have made several modifications for the Origin-PanCA assay to make it easy to use, accurate, and robust," he added.

However, there are some signs that the utility of tests that identify a cancer's origin in the body may be short lived, as clinical practice moves away from treating tumors based on their location, and turning more to therapies that are targeted at particular mutations or other genomic features, regardless of tumor type.

Clinical researchers in the US, for example, have begun to investigate whether, in a new era of molecularly targeted drugs, knowing where a cancer originated may be less important than knowing its genomic or other molecular features.

If the latter is true, sequencing-based analyses, either performed on tissue or potentially on circulating tumor DNA in the blood, may usurp approaches like CanHelp's — or those of the other companies in the US that offer similar tests.

In addition to the CUP test, CanHelp is also registering two other tests with Chinese regulators this year, Xu said — one for lung cancer and one for kidney cancer.

CanHelp's hTYPE-LUNG is a test that aids the discrimination of the two main histological subtypes of non-small cell lung cancer — adenocarcinoma and squamous cell carcinoma. Most of the time, this distinction is made via a simple morphological assessment of tumor tissue. But, according to CanHelp, this can be challenging and less effective in some poorly differentiated tumors.

If the company can demonstrate added value and clinical utility for gene expression over the standard histopathology examination, it would enter a much less crowded space than CUP.

In the US, LabCorp offers a laboratory-developed test called HistoPlus: Lung Cancer, which is licensed from GeneCentric and was initially developed by researchers at the University of North Carolina, and can distinguish between adenocarcinoma and squamous cell carcinoma. But few other commercial assays have targeted this clinical niche.

Similarly, CanHelp's third assay, hTYPE-RCC, is designed to help subtype cancers of the kidney. The company reported that the test, which involves qualitative detection of a 44-gene expression signature, allows the classification of the four most common types of kidney tumors, including benign oncocytoma and clear cell, papillary and chromophobe renal cell carcinomas.

In a study published last December in the Journal of Experimental & Clinical Cancer Research, researchers reported that a retrospective validation of the test demonstrated an accuracy of about 93 percent.

Similar to NSCLC subtyping, only one major commercial assay has so-far emerged for differentiating kidney cancers — Rosetta Genomics' microRNA-based Kidney Cancer Test, which the company has reported has 95 percent sensitivity and 98 percent specificity.

Xu said that CanHelp is only planning to commercialize its tests in China right now, but does have longer-term interest in also entering the US market. The company is also in active discussion with an unnamed partner in Europe, he added.

In Asia, the firm expects to launch its first test by the end of 2018 or beginning of 2019, based on the average timing of evaluations by China's FDA.

In the meantime, the company is working on what Xu said are about 10 clinical studies with various cancer centers in China to better establish and demonstrate the clinical validity and significance of the assays.

Next in line for development are gene expression tests for lymphoma and medulloblastoma, he added.