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In Brief This Week: Quidel, Ortho Clinical Diagnostics, T2 Biosystems, Agilent Technologies, More

NEW YORK – Quidel announced this week the completion of its combination with Ortho Clinical Diagnostics, creating QuidelOrtho. The company will be headquartered in San Diego, has approximately 6,000 employees, and will trade on the Nasdaq under the ticker symbol QDEL. The combined firm generated more than $3.5 billion in revenues in 2021.

Under the terms of the agreement governing the transaction, former Ortho Clinical Diagnostics shareholders received $7.14 in cash and 0.1055 shares of QuidelOrtho common stock for each Ortho common share. Former Quidel stockholders received one share of QuidelOrtho common stock for each share of Quidel common stock. The QuidelOrtho board is composed of eight former Quidel board members and four former Ortho board members.

T2 Biosystems said in a document filed with the US Securities and Exchange Commission this week that the US Food and Drug Administration has denied the company's application for breakthrough device designation for its T2Biothreat Panel. The firm said a US clinical trial for the panel is continuing and is expected to be completed this year. Data from the trial may allow the company to file for FDA clearance of the panel later this year.

Agilent Technologies said this week that it plans to expand its Little Falls office and lab campus in Wilmington, Delaware, in response to growing worldwide demand for analytical laboratory consumables. The company plans to invest more than $7 million to upgrade the functionality of the Little Falls R&D and applications development labs at a three-level, 354,000-square-foot site. The investment will support the redesign, demolition, construction, and outfitting of current laboratories. Agilent employs more than 800 people at Little Falls.

Cardio Diagnostics said this week that it has moved its headquarters to Chicago, where it will be based at Portal Innovations in Fulton Market. The company has been developing an AI-driven, epigenetics-based clinical test for cardiovascular disease called Epi+Gen CHD that assesses the risk for the onset of new coronary heart disease.

SQI Diagnostics this week posted a more than 18-fold year-over-year increase in second quarter revenues for fiscal year 2022. For the quarter ended March 31, the Toronto-based firm totaled revenues of C$5.6 million (US$4.4 million) compared to revenues of C$300,000 in Q2 2021. The company attributed the revenue growth to the acquisition of the Precision Biomonitoring COVID-19 testing business during the quarter for C$6.8 million in cash and stock, a deal that was announced in January.

The firm posted a fiscal Q2 gross profit of C$3.0 million compared to a gross profit of C$300,000 in the year-ago quarter. Its Q2 R&D expenses rose 33 percent year over year to C$2.8 million from C$2.1 million, mainly due to higher headcount, while its SG&A expenses rose 56 percent to C$2.5 million from C$1.6 million, primarily due to one-time costs for the Precision Biomonitoring acquisition.

At the end of Q2, SQI had cash and cash equivalents of C$1.5 million.

The company noted that during the quarter, the New York State Department of Health granted conditional approval to its diagnostic testing partner, KSL Diagnostics, for SQI Diagnostics' Exact COVID-19 Antibody Test.

Further, to finance the acquisition of the Precision Biomonitoring assets, SQI entered into a credit agreement with Pivot Financial, an arm's length third party, and certain insiders of the company. The agreement was for a short-term senior secured demand credit facility in the aggregate amount of C$7.5 million, bearing interest at 15 percent per year for two months. Following the quarter, the credit facility was extended for an additional two months and is due on June 11.

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.