360Dx Top 30 Drops 37 Percent in 2022

NEW YORK – After two years of a steep uptick in investor interest in diagnostics, driven by the demand in COVID-19 testing, 2022 saw the share prices of most diagnostic firms fall back to earth with a thud.

The decrease has also reflected an overall decline in the broader markets. For 2022, the 360Dx Index fell 37 percent year over year as the Dow Jones Industrial Average declined 9 percent in 2022. Meanwhile, the Nasdaq Biotech Index was down by 11 percent in 2022, and the Nasdaq Composite was down 33 percent in 2022.

The index's decline comes after 2021's year-over-year growth of 20 percent.

Of the 30 companies in the index, all but one saw their stock prices fall compared to 2021, Becton Dickinson (+1 percent). Meanwhile, the two companies with the lowest stock price drops were Hologic (-2 percent) and Quest (-10 percent). The main decliners were Dermtech (-89 percent), Invitae (-88 percent), and Accelerate Diagnostics (-86 percent).

Becton Dickinson, Hologic, and Quest Diagnostics had all previously benefited massively from COVID-19 testing, making it hard to beat the highs of 2021. Dermtech, Invitae, and Accelerate Diagnostics had comparatively low stock prices that made them susceptible to market fluctuations and also saw little benefit from COVID-19 testing.

While many companies saw quarterly results miss analyst estimates, BD beat analyst estimates during each round of revenue announcements in fiscal year 2022, even as revenues declined compared to 2021. The firm saw growth in its base business in each quarter, although COVID-19 testing revenues dropped steadily.

The firm also received multiple regulatory clearances for expanded COVID-19 tests, including CE-IVD marking for a high-throughput COVID-19 and influenza A/B test in May and CE-IVD marking for a combined COVID-19, influenza A/B, and respiratory syncytial virus panel in June.

Beyond respiratory diseases, BD received a myriad of clearances from the US Food and Drug Administration in 2022, including for its CTGCTV2 assay for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), and Trichomonas vaginalis (TV) and an automated sample preparation system for microbiology bacterial identification. In May, the firm received 510(k) clearance for a new molecular diagnostic module for its BD Cor system, the MX, and a triplex test for chlamydia, gonorrhea, and trichomonas on the system.

Hologic saw consistent declines in revenues throughout the year driven by decreasing COVID-19 testing but had some upside from regulatory clearances and a contract with the US government. The firm nabbed FDA approval for a quantitative cytomegalovirus test in May, as well as CE marking for two respiratory virus panels for SARS-CoV-2, influenza A/B, and respiratory syncytial virus.

Toward the end of the year, Hologic inked a $19 million contract with the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority to align its Panther Fusion combination respiratory virus test and its Aptima COVID-19 test with FDA in vitro diagnostic standards to gain regulatory approval.

Despite also being affected by declines in COVID-19 testing sales, Quest had a busy year on the acquisitions side of its business. The firm made multiple deals, acquiring patient engagement firm Pack Health for an undisclosed amount a year ago, purchasing select assets of Summa Health's outreach laboratory services business in October, and acquiring some of Northern Light Health's outreach lab services business in December, as well as striking a deal to provide management services for nine of the system's hospital labs and its cancer center lab.

The firm also hit a milestone when it received the first Emergency Use Authorization from the FDA for a monkeypox PCR test in September. It began offering the test in July.

Although it led the decliners, Dermtech saw good news throughout 2022, reporting revenue gains in each quarter compared to the prior year. However, it consistently missed Wall Street analyst estimates and saw flat sequential growth in the most recently reported quarter due to limited commercial payor coverage.

In contrast, fellow decliner Invitae had a busy year marked by restructuring and business divestitures. In July, the company announced it would eliminate non-core operations and geographies and focus on business lines that deliver sustainable margins and returns to fuel further investment, such as oncology, women's health, rare disease, and pharmacogenomics. It also laid off more than 1,000 employees.

Last month, the firm announced it has sold its portfolio of Archer next-generation sequencing research-use assays to Danaher subsidiary Integrated DNA Technologies for $48 million after it acquired ArcherDx in 2020 for about $1.4 billion.

Accelerate Diagnostics has emphasized its difficulty growing its business during the COVID-19 pandemic but made strides this year, launching a new system for MALDI mass spectrometry and updating its Pheno platform. The firm also struck a deal with Becton Dickinson for BD to sell the Pheno system and Accelerate Arc module, along with associated test kits.

The company also underwent a $35 million public offering of its stock in August. Like Dermtech, Accelerate's low stock price makes it more susceptible to wide swings, percentage-wise.

Note: The 360Dx Top 30 will be updated with new entries next month. We reconfigure the list at the beginning of each year based on market cap. As a reminder, we only consider firms for this list that trade common stock on one of the major US stock exchanges.

*Dermtech was added to the index in January 2022.

**Renalytix was also added to the index in January 2022.