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In Brief This Week: Quotient Limited, Bio-Rad, Danaher, and More

NEW YORK –  Quotient Limited said this week it has received a request from the US Food and Drug Administration for additional testing data relating to the company's 510(k) submission for the Initial Serological Disease Screening Microarray (SDS) and MosaiQ instrument. The Swiss firm said that the requested data relates to specific individual performance characteristics of the assays on the microarray. Quotient intends to resubmit its application with the requested data in early 2021 and is targeting clearance in mid-2021. The company said it does not believe it will be materially impacted by the request for additional data. Quotient CEO Franz Walt added in a statement that the request is not expected to impact the commercial launch of the MosaiQ platform in the US. Last month, the firm said that the instrument and SDS was anticipated to receive 510(k) clearance by the end of 2020. 

Oxford Immunotec said this week that South Korea's Ministry of Food and Drug Safety has approved the company's T-Cell Select reagent kit. The kit is an immune cell separation reagent used to automate the preparation of cells required to run Oxford Immunotec's T-Spot.TB test for diagnosing tuberculosis infection from patients' blood samples. It streamlines and simplifies the T-Spot.TB test laboratory protocol. Automation makes implementation of the assay easier, while reducing hands-on time and labor costs. The kit also allows for higher throughput and easier integration of the assay into the lab workflow, Oxford Immunotec said. The reagent kit is CE marked and available throughout Europe.  

Progenity this week announced it has closed its private offering of $85.5 million aggregate principal amount of 7.25 percent convertible senior notes due 2025. The notes issued include $10.5 million principal amount of notes issued from an option to purchase additional notes. Entities affiliated with Athyrium Capital Management acquired $103.5 million in notes, with $25 million to be purchased in cash and $78.5 million issued in exchange for the discharge of outstanding amounts in Progenity’s credit and security agreement with Athyrium.  

The San Diego, California-based firm also announced the closing of its public offering of 7,645,259 shares of common stock at a price of $3.27 per share. Both offerings combined generated proceeds of $110.5 million, which Progenity said it will use to support operations, invest in molecular testing and precision medicine R&D, and for working capital and general corporate purposes. 

Bio-Rad Laboratories said this week that it anticipates fiscal year 2023 sales to be in the range of $2.75 billion to $2.85 billion. The Hercules, California-based company said business will be driven by its broad portfolio of products including Droplet Digital PCR, single-cell, and clinical diagnostics, and a focus on the bioproduction and biopharma channels. 

Blue Shield will reimburse all of DermTech's products under an agreement announced this week. The deal becomes effective on Feb 1, 2021. The insurer has about 3.7 million covered lives through its commercial PPO/ EPO, Medicare Advantage PPO, commercial HMO and Medicare Advantage HMO plans. DermTech offers the Pigmented Lesion Assay, a noninvasive gene expression test for the early detection of melanoma. The test has a 99 percent negagive predictive value, La Jolla, California-based DermTech noted.

Biocartis said this week this has signed an agreement with an unnamed holder of its outstanding €150 million ($182 million) 4 percent senior unsecured convertible bonds due 2024 regarding the exercise of conversion rights in relation to €15 million aggregate principal amount of bonds. As part of the conversion, the firm will make a cash payment equal to €28,700 per €100,000 in principle amount, in addition to any accrued but unpaid interest.  The firm will convert an aggregate principal amount of €15 million and issue 1,163,575 new ordinary shares.  

Biocartis will use the funds to reduce the reported debt and strengthen its shareholders' equity at a premium to the current share price. The debt reduction amounts to €9.3 million, or €.08 per share, with a total reduction of €13.6 million, the company said.  

Telehealth firm IxLayer said this week it has been selected by the Chan Zuckerberg Biohub and Stanford University to provide its clinical testing platform for the Community Alliance to Test Coronavirus at Home (CATCH) study. CATCH is a large-scale research collaboration led by Stanford Medicine to test and track the coronavirus in the greater San Francisco Bay Area. It will leverage IxLayer's platform to run tests simultaneously with labs in California, track shipments, and manage test inventory, while providing data for scientists and public health officials to understand the area's outbreak and inform public health decisions. Through IxLayer, CATCH can reach more than 8.5 million residents in the San Francisco Bay Area with self-collection and the return of nasal swab samples, the firm said. IxLayer's platform is able to plug into a health system and lab within 48 hours, allowing physicians to prescreen patients, order tests, coordinate sample collection, and triage patients. 

Danaher said this week its board of directors has approved an $.18 per share quarterly dividend of its common stock, payable on Jan. 29, 2021 to shareholders of record on Dec. 28. The board also approved a quarterly cash dividend of $11.88 per share of its 4.75 percent Series A Mandatory Convertible Preferred Stock, payable on Jan. 15 to holders of record on Dec. 31. In addition, the board approved a quarterly cash dividend of $12.50 per share of its 5 percent Series B Mandatory Convertible Preferred Stock, payable on Jan. 15 to holders of record on Dec. 31. 

Abbott announced this week it has increased its quarterly common dividend to $.45 per share, a 25 percent increase. It will be payable on Feb. 16, 2021 to shareholders of record at the close of business on Jan. 15.  

Luminex this week announced a $.01 increase in its quarterly dividend to $.10 per common share, payable on Jan. 14, 2021 to stockholders of record at the close of business on Dec. 23. 

Australian digital diagnostics company Ellume said this week it has received a strategic investment from the Queensland State Government under the $50 million Essential Goods and Supply Chain Program. The company declined to disclose the amount of funding it received but said it will allow the company to expand its manufacturing facility in Brisbane, adding multiple production lines to improve production capacity of its rapid diagnostic tests for infectious diseases. Ellume said it is on track to ship 100,000 tests per day starting next month and 250,000 per day by March 2021, and it plans to manufacture 20 million SARS-CoV-2 tests in the first half of 2021. The firm is developing three SARS-CoV-2 tests, including an antigen test with Qiagen and two rapid antigen tests independently. It also previously developed a SARS-CoV-2 serology test with Qiagen that was launched in August.  

French IVD and theranostics firm Theradiag said this week it has obtained a €1.9 million ($2.3 million) state guaranteed loan from an unnamed bank syndicate. The loan is 90 percent guaranteed by the French government, Theradiag said, adding it has an initial maturity of 12 months and has an extension option, which allows the company to defer payment of the principal for up to five years. In June, the company reported a preliminary 2 percent revenue drop for the first half of 2020. 

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.