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In Brief This Week: Hologic, Quidel, Illumina, Guardant Health, and More

NEW YORK – Hologic said this week that the financial outlook for its current fiscal third quarter has improved since April 29 when it reported second-quarter financial results and discussed the impact of the COVID-19 pandemic. In a filing with the US Securities and Exchange Commission, the company said its diagnostics business has "significantly outperformed based on strong sales" of its COVID-19 tests.

Hologic anticipates that diagnostics revenues will grow 20 percent to 25 percent year over year during this fiscal quarter, with more than 75 percent of the quarter completed.

The company added that its breast and skeletal health businesses have performed in line with expectations and its surgical business has begun to recover more rapidly than anticipated. Breast and skeletal health revenues are expected to decline 30 percent to 35 percent, and surgical revenues are expected to decline 65 percent to 70 percent.

The firm also said that because the scope and duration of the COVID-19 pandemic remain highly uncertain, it cannot quantify its longer-term financial effects.

Quidel said this week that it has received an amended Emergency Use Authorization from the US Food and Drug Administration allowing it to run its Sofia SARS Antigen FIA, a rapid point-of-care test for COVID-19, on the Sofia Fluorescent Immunoassay Analyzer. The automated instrument, also called Sofia 1 because it is a first-generation product, provides results in 15 minutes, Quidel said.

The company had received EUA in May to run the Sofia SARS Antigen FIA on the second-generation Sofia 2 instrument.

Separately, the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) said this week that it has awarded $634,643 to Quidel for the development of a four-analyte antigen test on the Sofia 2 instrument.

About 20,000 Sofia 1 instruments are installed in hospitals and physician offices, and more than 43,000 instruments are placed worldwide for both Sofia models, Quidel said.

The US Securities and Exchange Commission (SEC) announced it will accept a settlement with a former Illumina accountant accused of insider trading.

Jana Kiena will pay disgorgement of $249,228 and a civil penalty of $124,613. Kiena shorted Illumina’s stock in July 2019 after receiving information from an accounting manager that the firm would post disappointing revenues in the second quarter of 2019. But within a month, Kiena self-reported her trading, the SEC said.

Guardant Health this week closed a previously announced underwritten public offering of 13,225,000 shares of its common stock, at a price of $84.00 per share. Guardant sold 4,312,500 of the total shares and SoftBank Investment Advisers sold the remainder, with JP Morgan Securities acting as a sole book-running manager.

The gross proceeds to Guardant from its portion of the shares, before deducting underwriting discounts, commissions, and other expenses, were approximately $362.3 million. The firm didn't receive any proceeds from the sale of its stock by SoftBank.

OncBioMune Pharmaceuticals announced this week that it has purchased all assets of molecular profiling company Avant Diagnostics and will soon change its name to Theralink Technologies. Avant's Theralink assays offer personalized medicine data to help physicians make decisions about treatment support and enable biomarker-based patient therapy selection. Avant also develops phosphoproteomic technologies to measure the activation state of therapeutic targets and signaling pathways, with applications for multiple cancer types, including breast, non-small cell lung, colorectal, gynecologic, and pancreatic cancer.

To pay for Avant’s assets, OncBioMune issued shares of its Series D-1 convertible preferred stock, which will convert to 4.4 billion shares of common stock once OncBioMune amends its articles of incorporation. As a closing condition for the acquisition, OncBioMune also raised $1.08 million in Series C-2 convertible preferred stock in a private placement from the Cavalry Fund and Lincoln Park Capital.

InCellDx said that its next-generation HPV cervical cancer assay, OncoTect 3Dx, has received marketing approval from the Costa Rican Ministry of Health. The assay simultaneously detects and quantifies three molecular markers of cervical cancer — overexpression of oncogenes (E6, E7 mRNA), proliferation, and aneuploidy. The assay runs on a high-throughput flow cytometry platform, allowing 96 cervical cytology samples to be tested and providing results in less than four hours, the firm said. The assay aids in the determination of which patients need to be further evaluated for the presence of high-grade cervical intraepithelial neoplasia. The HPV OncoTect 3Dx system received the CE mark two years ago.

Seven Bridges said this week that CareDx has chosen the Seven Bridges platform to decrease the time it takes to get results from the AlloSure kidney transplant testing workflow. The use of the Seven Bridges platform and automation products speeds time-to-results by minimizing the number of manual steps required to set up, run, and conclude an analysis, the company said.

Sekisui Diagnostics said this week that the Osom Ultra Plus Flu A&B Test has been CLIA waived. The rapid immunochromatographic assay detects influenza types A and B nucleoprotein antigens from swab specimens taken from patients with symptoms of respiratory infection. It received 510(k) clearance from the US Food and Drug Administration in May.

Iceni Diagnostics said this week it has received a UK government award of £50,000 ($63,235) to accelerate the development of its COVID-19 test, which is intended for triaging patients. The Norwich, UK-based company is developing the rapid, point-of-care test to differentiate SARS-CoV-2 from more common strains of influenza using artificial glycan receptors.

Bio-Techne said this week that its Exosome Diagnostics business has partnered with Zero–The End of Prostate Cancer, a nonprofit organization engaged in the fight against prostate cancer.

Zero provides support for millions of men with prostate cancer, including raising awareness and education for technologies, such as the Exosome Diagnostic's ExoDx Prostate test, a urine-based genomic test that helps inform the prostate biopsy decision.

GeneStore France said this week that its Detection Expert SARS-CoV-2 RT-PCR Test for detecting the coronavirus has been approved by CNR France, a National Institute of Reference. According to a company spokesperson, the test received the CE-IVD mark in April. Tests for detecting the coronavirus need to be CE marked and have CNR approval "through an external performance analysis" to be marketed in France, she said.

Australian company Sienna Diagnostics said this week that it has entered a research collaboration with the University of California, Los Angeles Ronald Regan Medical Center to investigate the use of Sienna’s telomerase detection technology as an adjunct test in fluid samples used for cytological examination. The work will help guide Sienna to develop an in vitro diagnostic test for detecting telomerase in a range of cytology samples. Financial and other terms of the deal were not disclosed.

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.