360Dx Top 30 Plummets 17 Percent in January

Editor's note: Welcome to our revamped version of the 360Dx Index, which is now called the 360Dx Top 30. The table and accompanying analysis each month will track the stock performance of the top 30 firms by market cap that we cover in the diagnostics industry that meet certain coverage criteria. Companies can be based outside the US but must trade common stock, not ADRs, on a US exchange.

NEW YORK – The 360Dx Top 30 dropped 17 percent month over month in January, reflecting a downturn in the broader economic markets. 

The Dow Jones Industrial Average fell 3 percent month over month from December, while the Nasdaq dropped 9 percent. The Nasdaq Biotech Index fell 12 percent.

The 360Dx Top 30's only gainers last month were Meridian Bioscience (+2 percent), Becton Dickinson (+1 percent), and Castle Biosciences (+1 percent). The decliners were led by Adaptive Biotechnologies (-38 percent), Fulgent Genetics (-37 percent), and Accelerate Diagnostics (-36 percent).

Meridian Bioscience likely saw a rise in its share price due to positive regulatory news, as it announced at the beginning of last month that its Curian Campy assay for the detection of Campylobacter infection received clearance from the US Food and Drug Administration. The rapid immunoassay detects a Campylobacter-specific antigen found in four types of the bacteria.

In addition to the firm's FDA clearance, earlier this week it announced that the National Institutes of Health awarded Meridian an additional $2.5 million to develop its molecular respiratory panel to run on the Revogene instrument. The award is an expansion of a previous $5.5 million award received last year to support the research, development, and manufacturing of the respiratory panel.

Becton Dickinson also had a spate of news last month, including the announcement that its BD Kiestra IdentifA system received 510(k) clearance from the FDA. The system automates the sample preparation component of microbiology bacterial identification.

Also in January, the firm said that it has partnered with Pfizer and charitable foundation Wellcome to study the role of diagnostics in supporting antimicrobial stewardship practices. The collaborators will survey existing diagnostic practices to understand the benefits and gaps in diagnostic testing in antimicrobial resistance stewardship.

Castle Biosciences' key news last month was the announcement of its preliminary Q4 and full-year 2021 revenues. The firm said it expects to meet or exceed the top end of its previous full-year 2021 guidance of $89 million to $93 million. It also noted that volumes for its DecisionDx-Melanoma, DecisionDx-SCC, MyPath Melanoma, DecisionDx DiffDx-Melanoma, and DecisionDx-UM tests all grew during both the fourth quarter and full year.

In an analyst note, SVB Leerink's Puneet Souda said that the company is "looking forward to a catalyst-filled" first half of 2022, as local coverage determinations from Medicare should allow strong volumes for its DecisionDx-SCC and DecisionDx DiffDx-Melanoma tests to materialize. Both of the tests have been submitted to the Centers for Medicare and Medicaid Services' MolDx program for reimbursement.

Among the decliners, the main news from Adaptive Biotechnologies last month was also the announcement of its preliminary 2021 revenues, which it said would likely be between $153 million and $154 million, compared to $98.4 million in 2020.

Meantime, during a presentation at the JP Morgan Healthcare Conference in January, Accelerate Diagnostics announced that its total Q4 2021 revenues are expected to be about $3.3 million, up 6 percent from $3.1 million in the fourth quarter of 2020. Full year revenues are expected to be $11.8 million, up 5 percent from 2020, and full-year 2022 revenues are estimated to be $13 million.

Accelerate CEO Jack Phillips also provided a strategy update at the conference, saying that new products, a growing sales funnel, and greater access to customers will lead to higher future growth for the company. The firm will continue to penetrate the antimicrobial susceptibility testing market with its Pheno rapid ID-AST solution and AST test kit, he said, and will then enter the "untapped and sizable" market for rapid MALDI with its automated sample prep system Arc. Then, the firm will launch its Pheno 2.0 system to address the entire market for acute bacterial infections "beyond just positive blood cultures," he said.

Fulgent Genetics had no significant news during the month to explain its decline.

*Abbott paid a dividend of $.47 on Jan. 13.

**PerkinElmer paid a dividend of $.07 on Jan. 20.

***Quest Diagnostics paid a dividend of $.62 on Jan. 18.