360Dx Top 30 Rebounds in 2024, Rises 4 Percent

Editor’s Note: We will adjust the firms listed in the 360Dx Top 30 this month based on market caps at the end of 2024. Those changes will be reflected next month when we report on the stock performance in January of the companies we track.

NEW YORK – After two years of decline in 2022 and 2023, the 360Dx Top 30 rebounded in 2024, rising 4 percent year over year.

The increase correlated with an overall uptick in the broader markets as the Dow Jones Industrial Average rose 13 percent during the past year, while the Nasdaq Composite rose 29 percent. The Nasdaq Biotech Index, however, declined 1 percent in 2024.

Of the 30 companies in the index, the highest gainers were GeneDx (+2,695 percent), Natera (+153 percent), and CareDx (+78 percent). The main decliners were Quanterix (-61 percent), OraSure Technologies (-56 percent), MDxHealth (-40 percent), and QuidelOrtho (-40 percent).

GeneDx, formerly known as Sema4, saw its stock price rise consistently over 2024, starting from less than $3.00 per share in January and rising to $76.86 by the end of December. The firm's positive financial results over the course of the year benefited the firm, as it announced revenues were up 51 percent in Q1 thanks to skyrocketing whole-genome and whole-exome test volumes.

The trend continued throughout the year, with the firm reporting 45 percent growth in Q2 and 44 percent growth in Q3 due to increased revenue from exome and genome sequencing tests. In Q3, the firm reached profitability on a non-GAAP basis and its testing volume increased 46 percent.

On a call to discuss the Q3 financial results, GeneDx CEO Katherine Stueland said that the firm is "bullish on our ability to keep expanding our footprint in the pediatric outpatient setting and begin extending our reach into new clinical settings in the years to come."

In July, investment bank Craig-Hallum initiated coverage of GeneDx with a Buy rating and a $43 per share price target. Craig-Hallum analyst Bill Bonello wrote in a note to investors that the company can generate "sustainable" growth in its whole-exome and whole-genome sequencing businesses with improving gross margins.

"What differentiates GeneDx from these competitors is bioinformatics and data analysis," Bonello noted. "The company is an expert at processing whole exomes and whole genomes, efficiently and at scale."

GeneDx also throughout the year entered into multiple partnerships, including one last month with Biogen, Praxis Precision Medicines, and Stoke Therapeutics to provide pediatric epilepsy patients with access to whole-exome sequencing. In June, the company announced it was collaborating with electronic health record software firm Epic Systems to integrate rapid whole-genome sequencing results with Epic's Aura diagnostics suite for patients in neonatal intensive care units.

Fellow gainer Natera was also boosted by consistent positive financial results throughout last year, starting with the announcement in February that its Q4 2023 revenues rose 43 percent year over year. Q1 2024 revenues rose 52 percent due to increased testing volumes and improvements in average test selling price, while Q2 revenues rose 58 percent. The company's Q3 revenues were up 64 percent, leading Natera to raise its full-year 2024 financial guidance.

Earlier in the year, Natera acquired Invitae's reproductive health assets for up to $52.5 million, including carrier screening and noninvasive prenatal screening tests.

The company also saw multiple legal wins throughout 2024. In January, a jury awarded Natera $96.2 million in damages in a patent infringement case against CareDx after it found that CareDx infringed on one of Natera's patents covering its Panorama noninvasive prenatal testing assay technology.

In September, Natera was granted a permanent injunction against NeoGenomics Labs' RaDaR assay in the US as part of the settlement of a separate patent infringement lawsuit Natera brought against NeoGenomics.

However, in November the firm was ordered to pay $292.5 million in damages to Guardant Health related to a false advertising lawsuit Guardant filed against Natera in 2021. Natera said it disagrees with the decision and will ask the court to overturn it. In its suit, Guardant alleged that Natera engaged in false advertising, unfair competition, and unlawful trade practices related to what it claimed were misleading statements about a study of the performance of Guardant's Reveal minimal residual disease assay.

Natera also saw positive momentum in garnering insurance coverage for its assays throughout 2024. In February, Natera announced that the US Centers for Medicare and Medicaid Services would begin reimbursing its Signatera minimal residual disease test in ovarian cancer in the adjuvant and surveillance settings and breast cancer in the neoadjuvant setting.

In March, Blue Cross Blue Shield of Florida said it would cover donor-derived cell-free DNA-based transplant rejection tests, including Natera's Prospera Heart and Prospera Kidney tests and CareDx's AlloMap and AlloSure assays, and at the end of November, Natera announced that CMS will cover its Prospera Lung test for single lung transplant patients in the surveillance setting.

CareDx, the other largest gainer for 2024, was also buoyed by its financial results, as well as positive clinical data. Although it started the year by announcing its Q4 2023 revenues fell 20 percent in part due to a change in Medicare reimbursement for transplant testing, the firm still beat Wall Street analysts' consensus revenue estimates.

The reimbursement change also impacted the firm's Q1 2024 financial results, which declined 7 percent. However, CareDx raised its full-year 2024 revenue guidance that same quarter because the results were better than anticipated. That billing change and a related proposed local coverage determination were later rescinded by CMS, leading investment bank BTIG to upgrade its rating for CareDx to Buy from Neutral.

The company's Q2 revenues rose 31 percent year over year, while its Q3 results rose 23 percent. After the announcement of its Q3 results, CareDx raised its full-year 2024 guidance again.

The firm's shares also surged in June after the publication of a large peer-reviewed study demonstrating the utility of the company's AlloSure test for improving the detection, characterization, and treatment of kidney allograft rejection.

Quanterix saw its share price steadily decline throughout the year without a clear reason, although the proteomics firm plays in the increasingly crowded blood-based Alzheimer's diagnostics field. More firms have joined the quest for high-sensitivity blood-based testing for Alzheimer's biomarkers, including large diagnostic firms like Roche, Danaher's Beckman Coulter, Quest Diagnostics, and Laboratory Corporation of America. Although it posted revenue growth in each of its financial quarters, questions surrounding payor coverage for blood-based Alzheimer's tests and defensibility of intellectual property claims may have concerned investors, resulting in a declining stock price.

In contrast to the above companies, OraSure Technologies saw consistent declines in revenues throughout 2024. The firm reported that its core revenues in Q4 2023 were essentially flat, and it reported core revenue declines in each of the subsequent quarters.

However, the company announced positive news at the end of the year that may signal the tide is turning. In November, the company received millions from the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA) for biothreat assay development.

And at the end of December, the firm announced it has acquired Sherlock Biosciences for up to $25 million. Sherlock is expected to help expand OraSure's presence in rapid diagnostics for sexually transmitted infections and in molecular diagnostics.

Among other decliners, MDxHealth had little news to explain its declining share price, although it has a particularly low starting share price that makes it susceptible to small fluctuations in the broader markets.

QuidelOrtho's declining stock price was evidence of its tumultuous year, starting with the miss of its Q4 2023 revenue and full-year 2023 guidance in February. The miss was attributed to lower-than-expected sales of COVID-19 and influenza testing and resulted in the firing of longtime CEO Douglas Bryant one day later.

In April, the company withdrew its US Food and Drug Administration submission for its planned RVP4 respiratory panel because the data did not meet QuidelOrtho's expectations. The next month saw Brian Blaser assume the role of CEO, accompanied by workforce reductions and the suspension of the firm's full-year financial guidance to allow Blaser to review the business.

However, in November, the company reinstated its full-year guidance and said it had flattened its organizational structure by reducing the number of executives and reorganizing its sales structure. The news caused the firm's stock price to rise nearly 17 percent on the day of the announcement.