NEW YORK – Having just signed a distribution agreement for its neuroendocrine tumor liquid biopsy diagnostic tests in China, Wren Laboratories is conducting clinical studies on a prostate cancer diagnostic assay, while pressing on with further global expansion.
The Branford, Connecticut-based company has been busy widening the distribution of its NETest neuroendocrine tumor diagnostic assay and companion NETest PPQ test to predict response to peptide receptor radionuclide therapy (PRRT) throughout the US and Mexico, while advancing its pipeline of prostate, breast, lung, and colon cancer tests.
Beyond Mexico and China, Wren is also in early discussions with a lab in Japan about another distribution agreement, and is eyeing other parts of the world, according to Daniel Buck, Wren's general manager.
Wren focuses on circulating tumor mRNA as a diagnostic biomarker. While DNA mutations, epigenetic changes, and proteins all constitute useful biomarkers of various cancer processes, Mark Kidd, Wren's scientific and laboratory director, said he sees RNA as the most informative choice. "Ultimately the signal, the message that cells get, comes from RNA," he said.
Kidd and Irvin Modlin, now a clinical and scientific consultant for Wren Labs, founded the company 10 years ago based on research the two had conducted at Yale University on neuroendocrine tumors.
These rare tumors comprise an estimated 2 percent of all cancers and can be difficult to treat as the hormonal symptoms often associated with them can delay proper diagnosis, leading to a large unmet need for better diagnostic tools.
Kidd, Modlin, and their colleagues discovered a 51-gene signature characteristic of NETs, which forms the basis of the NETest. For that, Wren measures expression of these genes in blood via quantitative PCR (qPCR) and analyzes the results using a proprietary algorithm to calculate how likely a patient is to have a neuroendocrine tumor or neoplasia.
Kidd explained that the test is made even more useful by the addition of NETest PPQ, which predicts PRRT response based on the expression of an eight-gene subset of the NETest and the histological grade of the tumor, classifying patients as either "responders" or "non-responders."
"It's useful to monitor whether the therapy is working or not, but it's probably more valuable to identify whether someone should be treated," he said.
Kidd likened the NET-associated mRNA to a needle in a haystack and said that qPCR best enabled Wren researchers to tease out the cancer signal from the background noise. "We found that amplifying the signal using PCR was a very good way of finding that needle," he said.
Other cancer test developers appear to agree. Mainz Biomed's ColoAlert assay for colorectal cancer, for example, and Apis Assay Technologies' Breast Cancer Subtyping Kit are both PCR-based. In contrast to Apis' and Wren's kits, however, ColoAlert is a multianalyte test that assays DNA and proteins in addition to mRNA.
"The three different modalities are complementary, because they interrogate alterations or signals at different molecular and phenotypic levels, ultimately indicating presence of cancer," Guido Baechler, CEO of Mainz Biomed, said via email. "Combining those increases sensitivity and specificity of the detection and allows for superior performance across different stages of the disease."
Baechler added that Mainz Biomed is also evaluating the human microbiome as another potential biomarker for its cancer tests.
Apis also takes a biomarker-agnostic approach to assay development, having built an assay pipeline that encompasses DNA, ctDNA, mRNA, miRNA, noncoding RNA, proteins, methylation products, and protein modifications. "The selection of a specific biomarker is driven by various factors, including its applicability to the intended purpose, its capacity to accurately pinpoint the disease state of interest, and the sensitivity and specificity it offers," a company spokesperson said in an email.
As Wren continues to expand the availability of its NETest, the company is preparing for the launch of its next diagnostic assay — the prostate cancer PROSTest. According to its website, the assay measures the expression of 27 genes in blood and was able to identify prostate cancer with more than 90 percent accuracy in a study.
"We are finalizing a couple of clinical studies," Kidd said, "[and] we anticipate in the next 12 months or so for the PROSTest to come online."
Other assays are expected to become available some six to 12 months thereafter, he added, including tests for breast, lung, and colon cancer. All assays are lab-developed tests offered out of the company's CAP-accredited and CLIA-certified Branford lab. Wren NETest is currently approved as an LDT for patients residing in California and New York. In addition, the company intends to seek 510(k) clearance for that test.
Wren Labs hopes to establish a global presence for all its tests. Testing in overseas markets will be handled in the local distributors' labs. Kindstar, for example, plans to offer the NETest through its Beijing lab.
"I find it very exciting that the technology that we've developed is actually seen as being valuable and of utility, and we're getting requests to expand," Kidd said.
Earlier this month, Wren Labs signed a distribution agreement for China with Kindstar Globalgene Technology, which has plans to eventually distribute the test throughout Southeast Asia. Under the agreement, Wren Labs will receive sales-based royalties from Kindstar. Buck estimated that at least 300,000 patients in China could potentially benefit from NETest.
Wren Labs is a wholly owned subsidiary of West Indies-based Clifton Life Sciences and currently employs about 25 people.