In Brief This Week: Natera, Thermo Fisher Scientific, Fluidigm, and More

NEW YORK – Natera said in a regulatory filing with the US Securities and Exchange Commission earlier this month that a California appellate court on Feb. 28, 2020 upheld a ruling regarding several class action lawsuits in favor of the company. The suits were originally filed in 2016 against Natera, its directors, certain company officers, and certain stockholders, claiming that the registration statement filed by Natera in conjunction with its 2015 IPO had false or misleading statements or omitted material information.

In 2017, the court dismissed the claims and the plaintiffs filed an amended complaint later that year. In 2018, the court issued a judgment in favor of Natera's pleadings, which the plaintiffs appealed. Following the hearing of the appeal last month, the Court of Appeal for the State of California affirmed the judgment on the pleadings in favor of Natera on Feb. 28.

Following the announcement last week that Thermo Fisher Scientific intends to acquire Qiagen for $11.5 billion in cash, Thermo Fisher on Monday released additional details about the proposed deal, which the companies expect will close next year. 

In a document filed with the US Securities and Exchange Commission, the Waltham, Massachusetts-based company said that if the agreement is terminated under a number of circumstances, Qiagen will make a $367 million termination payment in cash to Thermo Fisher. If the agreement is terminated for another set of reasons, Thermo Fisher will have to give Qiagen a $575 million reverse termination payment in cash.

Fluidigm said this week that it has established a center of excellence (CoE) for imaging mass cytometry in Singapore in collaboration with the Singapore Immunology Network (SIgN), part of the Agency for Science, Technology, and Research (A*STAR). As the first CoE for imaging mass cytometry in Singapore and Southeast Asia, the center will focus on single-cell deep spatial immunoprofiling to demonstrate the utility of highly multiplexed imaging across a range of disease areas, such as cancer immunology. The center will be housed in SIgN's premises at Biopolis, Singapore's biomedical research hub, and will serve as a regional platform for scientific innovation, training, and services in mass cytometry and IMC and accelerate innovation in new product development and pre-commercial product testing. 

The Centers for Medicare & Medicaid Services announced last week that it has developed a second Healthcare Common Procedure Coding System code that can be used by laboratories to bill for SARS-CoV-2 diagnostic tests. The U0002 code allows labs to bill for assays not from the Centers for Disease Control and Prevention. Claims using this code can be submitted after April 1 for dates of service after February 4. Labs performing the CDC test should use code U0001. Medicare hasn’t established national payment rates for either code, so it’s currently up to the local Medicare Administrative Contractor to develop the payment amount for each code.

Companion diagnostic test developer Celcuity this week said that its net loss for the fourth quarter was $1.8 million, or $0.18 per share, and matched its net loss for revenues and earnings per share a year ago. The Minneapolis-based firm reported no revenues for Q4 and 2019.

Its Q4 R&D costs dropped 6 percent year over year to $1.5 million from $1.6 million, while its general and administrative costs increased slightly to $400,742 from $316,460 in Q4 2018.

The company posted a net loss for 2019 of $7.4 million, or $.72 per share, compared to a net loss of $7.5 million, or $.74 per share in 2018.

Celcuity's full-year R&D costs were flat year over year at $6.3 million, while its general and administrative costs were down 6 percent to $1.5 million from $1.6 million a year ago.

At the end of Q4, Celcuity had cash, cash equivalents, and investments of $18.7 million.

The firm's Chairman and CEO Brian Sullivan said in a statement that it "made significant progress" advancing its Celsignia platform in Q4. In December, Celcuity presented results from pre-clinical studies for its new Celsignia PI3K test at the San Antonio Breast Cancer Symposium. "The studies we presented demonstrate how the measurement of PI3K-involved signaling initiated by G-protein-couple receptors (GPCRs) using our Celsignia platform may provide a more sensitive and specific method than PIK3-mutational status to identify patients most likely to benefit from PI3K inhibitors," Sullivan said. 

Parsippany, New Jersey-based Interpace Diagnostics, a subsidiary of Interpace Biosciences, said this week that it has signed an agreement with Blue Cross Blue Shield Massachusetts to cover THyGenext and ThyraMir thyroid cancer detection as in-network services. The BCBS plan covers more than 3 million individuals in Massachusetts and New England. 

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.