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In Brief This Week: Seegene, Epigenomics, Qiagen, and More

NEW YORK (360Dx) – Diagnostics maker Seegene this week signed an agreement with Biogroup-LCD to supply the French consortium of laboratories with ₩10 billion ($8.9 million) worth of diagnostic kits. Seegene will supply one million PCR-based kits, including tests for sexually transmitted infections, women's health, and gastrointestinal infections.

Epigenomics said this week that that it has initiated a multi-center validation and development study of its methylated cell-free DNA biomarkers to aid in the detection of hepatocellular carcinoma in patients with cirrhosis. Epigenomics said that it recently CE marked its test, called HCCBloodTest, based on a published clinical study that demonstrated a sensitivity of 90.6 percent and specificity of 87.2 percent while also exhibiting higher diagnostic accuracy compared to alpha-fetoprotein (AFP), a widely used serum diagnostic marker for liver cancer. The company is now starting a cross-sectional, prospective clinical trial at three undisclosed medical centers to assess the biomarkers and validate the performance of the test in the US population. Epigenomics said that key findings from the study will bridge to a longitudinal study that will begin in the second half of 2019 and support a regulatory submission to the US Food and Drug Administration.

Qiagen announced this week that it will initiate the repurchase of a third tranche of shares under a share repurchase program the firm initiated on Jan. 31. Between Dec. 19, 2018 and March 8, 2019, up to 2.5 million of Qiagen's common shares worth a total purchase price of up to $70 million will be repurchased exclusively on the electronic trading platform of the Frankfurt Stock Exchange. The maximum purchase price per share will not exceed the average closing price for the last five trading days prior to the day of purchase on the electronic trading platform of the Frankfurt Stock Exchange by more than 10 percent.

QuantumDx and Molbio Diagnostics said this week they have signed a memorandum of understanding to work jointly in infectious disease diagnostics. The initial focus will be on genotypic drug resistance testing for patients infected with tuberculosis. The partners also said they will explore partnerships around portfolio development and target sequencing. Financial and other terms of the agreement were not disclosed.

PredictImmune said this week it received ISO 13485 certification. The UK firm called the certification "another significant step forward in [its] progress toward the January launch of its first prognostic biomarker test, PredictSure IBD." The test received CE-IVD marking earlier this month.

Quest Diagnostics announced that it has completed the previously announced sale of its India medical diagnostics business to Bangalore-based specialized diagnostics company Strand Life Sciences. The business ads three reference labs, 45 touchpoints, and leading corporate pharmaceutical clients to Strand's 24 diagnostic labs across India, according to Strand CEO Ramesh Hariharan. Terms of the transaction were not disclosed. 


In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.