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In Brief This Week: Roche, Quanterix, Ortho Clinical Diagnostics, Veracyte, and More

NEW YORK – Roche announced this week that its Elecsys Growth Differentiation Factor-15 (GDF-15) test received Breakthrough Device Designation from the US Food and Drug Administration as a companion diagnostic in cancer treatment. The quantitative serologic immunoassay measures GDF-15 in patients with solid tumors for treatment with Pfizer’s investigational drug PF-069446860. Elevated GDF-15 levels can indicate cachexia in cancer patients, a complication of cancer associated with involuntary weight loss, muscle atrophy, and reduced appetite that can also lead to death. The assay is intended for use on Roche’s Cobas e platform.

Quanterix said this week it has closed its public offering of 4,107,142 shares of common stock at $70 per share, raising gross proceeds of $287.5 million. The total share count offered includes 535,714 shares sold pursuant to the full exercise of the offering's underwriters' option to purchase additional shares. Goldman Sachs, SVB Leerink, and Cowen were the joint book-running managers for the offering, and Canaccord Genuity was the lead manager.

Ortho Clinical Diagnostics this week announced that some of its subsidiaries amended a June 30, 2014 credit agreement on Feb. 5. The amendment increased the revolving credit facility under the credit agreement by $150 million to an aggregate amount of $500 million, and extended the maturity date to Feb. 26, 2026, provided that such date may be accelerated subject to certain circumstances.

Veracyte said this week it has closed its previously announced public offering of 8,547,297 shares of common stock, including 1,114,864 shares sold upon full exercise of the underwriters' option to purchase additional shares, at a price of $74 per share. The firm raised about $593.8 million after deducting underwriting discounts, commissions, and estimated offering expenses.

Lucira Health said this week it has closed its upsized initial public offering of 10,305,000 shares of common stock at a public offering price of $17. The share total includes 1,350,000 shares sold pursuant to the full exercise by the underwriters of their option to purchase additional shares. The proceeds from the offering before deducting underwriting discounts, commissions, and estimated offering expenses were $175.95 million. BofA Securities and William Blair acted as lead bookrunning managers and LifeSci Capital was co-manager for the offering.

CareDx said this week that the underwriters of its previously announced public offering of common stock have exercised in full their option to purchase an additional 288,461 shares at the public offering price of $91 per share. CareDx will receive additional net proceeds of approximately $24.7 million. The option was granted in connection with the public offering of 1,923,077 shares of common stock, which closed on Jan. 25. After the underwriters exercised their full option, the company sold a total of 2,211,538 shares for approximately $188.7 million in net proceeds.

Goldman Sachs and Jefferies acted as joint book-running managers for the offering, and Raymond James, BTIG, Craig-Hallum Capital Group, and HC Wainwright acted as co-managers.

Oncocyte said this week that it has closed a previously announced public offering of 8,947,000 shares of its common stock, including 1,167,000 shares sold upon the exercise in full of a 15 percent over-allotment option by the underwriters. The shares sold at the public offering price of $4.50 and gross proceeds totaled approximately $40.3 million. Piper Sandler acted as sole bookrunner for the offering. BTIG and Needham acted as co-lead managers.

The company said it will use the funds to support the commercialization of its lead diagnostic test DetermaRx, to complete the development of its immunotherapy predictor DetermaIO, and for the development of future tests in its pipeline, including the CNI Monitor assay that it expects to acquire through a planned merger with Chronix Biomedical.

Yourgene Health this week lowered its revenue guidance for its fiscal year ending March 31, 2021. The company now expects revenues of £18 million ($24.7 million) to £20 million for the year, which is less than it previously expected. However, Yourgene still anticipates revenues to increase 10 percent to 20 percent year over year, driven by testing for cystic fibrosis, prenatal aneuploidy, and dihydropyrimidine dehydrogenase enzyme (DPD) deficiency in Europe.

Revenues in the second half of the current fiscal year were dampened by pandemic-related shortfalls in noninvasive prenatal testing outside of Europe. In addition, Yourgene saw lower-than-expected revenues from COVID-19 testing through the UK's Fit to Fly and Test to Release programs, as well as workplace and hospitality testing, delayed reproductive health contracts with US partners, and a suspended oncology research program by a client in Taipei.

For the coming fiscal year, ending March 31, 2022, Yourgene said it expects revenues of more than £25 million, but revenues could exceed this estimate, depending on when COVID-19 restrictions are lifted.

VolitionRx this week said it closed a previously announced public offering of 3,809,524 shares of its common stock for gross proceeds of approximately $20 million. The firm granted the underwriter for the offering a 30-day option to purchase up to an additional 571,428 shares.

Volition said it intends to use the net proceeds for general corporate purposes, which may include continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes, including potential strategic acquisitions.

Cantor Fitzgerald acted as the sole bookrunning manager of the offering.

Genetron Health said this week that its early liver cancer screening research results were mentioned in new guidelines issued by the Chinese Anti-Cancer Association for liver cancer prevention and treatment. The new recommendations specifically cite a study published by Genetron Health and China’s National Cancer Center in the Proceedings of the National Academy of Sciences, stating that methylation-based circulating tumor DNA tests like Genetron’s can help improve screening when added to traditional protein biomarkers.

Applied DNA Sciences this week reported that its first quarter revenues increased 155 percent to $1.6 million from $634,000 year over year, primarily due to an increase in service revenues of approximately $670,000 and an increase of $312,000 in product revenues. The increase in service revenues was primarily derived from sales of the company’s COVID-19 surveillance tests and the firm attributed the increase in product revenues to an increase in sales of its Linea COVID-19 assay kit. Applied DNA Sciences’ net loss for the quarter ended Dec. 31, 2020 was $4.8 million, or $.88 per share, compared with a net loss of $2.7 million, or $1.12 per share, for the previous year’s quarter.

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.