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In Brief This Week: OraSure, Singulex, Qiagen, and More

NEW YORK (360Dx) – OraSure Technologies reported a 31 percent year-over-year increase in its third quarter revenues, including a 186 percent rise in hepatitis C revenues.

For the three months ended Sept. 30, total revenues grew to $42.3 million from $32.3 million in Q3 2016. It beat the consensus Wall Street estimate of $40.8 million.

HCV testing revenues rose to $8.0 million from $2.8 million, while HIV testing revenues were up 13 percent year over year to $8.2 million from $7.3 million.

By market, infectious disease testing increased to $16.6 million from $10.4 million; risk assessment testing slid to $3.1 million from $3.5 million; cryosurgical systems fell to $2.9 million from $3.2 million; and molecular collections systems expanded to $18.6 million from $8.3 million.

OraSure's R&D spending was essentially flat at $3.2 million, while its SG&A costs grew to $14.1 million, up 6 percent year over year from $13.3 million.

The company's net income was trimmed to $5.8 million, or $.09 per share, from $6.2 million, or $.11 per share in Q3 2016. The analysts' average estimate was $.09 per share.

OraSure ended the third quarter with $78.6 million in cash and cash equivalents, and $83.4 million in short-term investments.


Singulex has filed a 510(k) submission with the US Food and Drug Administration for its Singulex Clarity cTnl assay to run on the Singulex Clarity system. The fully automated in vitro diagnostics platform leverages Singulex’s Single Molecule Counting technology, and the assay quantitatively measures cardiac troponin at levers “far lower than existing technologies,” Singulex said. It added that the indication submitted to the FDA is for use in conjunction with clinical evaluation as an aid in the diagnosis of myocardial infarction.


Qiagen has launched a custom solutions business to provide life sciences and molecular diagnostics companies with tools and expertise to quickly build and commercialize products. The new business will offer custom and OEM sample technologies; oligos and enzymes for PCR, qPCR, and next-generation sequencing product development; and a broad range of other platform technologies. Qiagen noted that approximately 10 percent of its sales have been reinvested in R&D to help support the new Custom Solutions business.


Labi Exames, a network of medical laboratories, has launched in Brazil, providing millions of uninsured Brazilians access to laboratory testing. Marcelo Noll Barboza, one of Labi’s founders, said that the goal is to serve 3 million patients per year by 2022. Octavio Fernandez, a cofounder of Labi, its VP of operations, and a clinical pathologist, noted that only 25 percent of Brazilians have health insurance.


UK-based liquid biopsy firm Angle said that it has completed the fundraising and acquisition of certain assets of Axela. In October, Angle said that it intended to acquire intellectual property, fixed assets, inventory, employees, a property leasehold interest, and other assets microarray firm Axela for a total of £3.7 million ($4.9 million). To fund the acquisition, the company proposed a placing of shares and subscriptions that would raise approximately £12.2 million ($16 million) before expenses. 

By acquiring Axela, Angle hopes to expand its liquid biopsy capabilities by pairing its Parsortix circulating tumor cell system with a multiplex tool for measuring DNA, RNA, and protein expression


Co-Diagnostics was granted ISO 13485:2016 certification following an audit of its quality management system in August. The company’s certificate is valid until September 2020. The scope of the certificate includes the design and manufacture of medical products for handling, stabilizing, separating, purifying, amplifying, and detecting nucleic acids, the firm said.


Almac has acquired all the shares of BioClin Laboratories, an Athlone, Ireland-based organization providing analytical services, including GMP microbiology testing and GLP bioanalysis. Terms of the transaction were not disclosed.

The deal expands Almac’s analytical capacity and complements its existing business, Almac said. It added that it recently completed expanding its analytical facilities at its global headquarter site in Northern Ireland with the creation of a new MHRA-approved laboratory.


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