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In Brief This Week: Amydis Diagnostics, Singulex, Neogen, and More

NEW YORK (360Dx) – Amydis Diagnostics said that the National Institute on Aging had awarded it a Phase 2 SBIR grant of $1.8 million to fund R&D into an ophthalmic diagnostic probe for Alzheimer's disease.

The ability to identify amyloid-beta deposits helps in identifying patients at risk for Alzheimer's disease and enables enrollment of patients in clinical trials investigating disease modifying treatments, and may ultimately guide therapeutic intervention at an early stage, the firm said in a statement.

Current diagnostic procedures to detect amyloid-beta in the brain are based on brain imaging techniques or biochemical assays following an invasive procedure.

Amydis aims at establishing less costly, noninvasive diagnostic procedures based on ophthalmologic procedures.

"This grant provides rigorous peer-reviewed validation…and allows us to further develop and take our promising technology to the marketplace for the detection of amyloid-beta deposits as a diagnostic for Alzheimer's disease," Stella Sarraf, Amydis Diagnostics Founder and interim CEO said in a statement.

Singulex said that it is expanding clinical evaluation of its Sgx Clarity system, an in vitro diagnostics platform currently under development that uses the firm's single-molecule counting technology to help clinicians better understand heart disease status

Multiple clinical research studies are underway at a site in Spain and two sites in the UK, the firm said.

The firm's technology has already "proven to allow greater analytical and clinical sensitivity and understanding of how biomarkers can guide health status," Jorge Ordonez-Llanos, professor of clinical biochemistry at Hospital de Sant Pau, Barcelona, said in a statement. Ordonez-Llanos noted that his group has demonstrated the system's "improved detection limit, analytical precision, and functional sensitivity," and it is expanding clinical research studies "to explore applications of the cardiac troponin-I biomarker to better manage patients and bring cost savings to our hospital."

Neogen this week reported its fiscal third quarter revenues grew 15 percent to $88.4 million from $76.7 million in the prior-year quarter.

For the three months ended Feb. 28, food safety revenues rose to $42.9 million, up 24 percent from $34.7 million in the prior-year quarter. A 29 percent increase in sales of the firm's rapid tests for natural toxins led third quarter food safety sales performance, the firm said. In 2016, a bumper corn crop in the US, Canada, and Europe drove toxin testing growth. Sales of Neogen’s test kits to detect food allergens — such as gluten, milk, and peanuts — grew 14 percent in Q3, driven in part by an increase in "global food allergen regulatory efforts," Neogen said.

Animal safety business revenues were $45.4 million, up 8 percent from $42 million in Q3, 2016. Rapid tests to detect drug residues in forensic samples drove 39 percent growth in this segment over the prior-year quarter, and was due to "a significant increase in sales of drug detection kits to commercial labs," the firm said.

"In the quarter, we continued to see increased sales of our diagnostic test kits as we responded to an outbreak of the mycotoxin [deoxynivalenol] in corn and wheat crops, and increased demand of allergen test kits due to continued food recalls regarding the detection of unlabeled food allergens," Neogen President and Chief Operating Officer Richard Calk said in a statement.

For Q3, the firm reported net income of $10.3 million, or $0.27 per share, compared to $8.3 million, or $0.22 per share in the prior-year quarter.

The firm finished the quarter with cash and investments of $124.6 million.

Alere this week declared a cash dividend of $3.00 per share on its Series B Convertible Perpetual Preferred Stock, payable on April 17 to shareholders of record of the Series B stock as of the end of the business day on April 3.

Hologic said this week that it has completed the acquisition of Cynosure, a medical aesthetics systems and technologies entity, for $66 per share in cash. At the time the deal was announced, Hologic said the equity value of the deal was $1.65 billion.

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.