NEW YORK – Despite broader market downturns, demand for PCR-, rapid antigen-, and antibody-based SARS-CoV-2 tests drove significant increases in share price for many diagnostic firms throughout the first half of 2020.
The 360Dx Index increased 17 percent from December 2019 to June 2020, with multiple firms seeing share price jumps of 100 percent or more. In contrast, the Dow Jones Industrial Average decreased 10 percent over the same period, although the Nasdaq grew 12 percent, and the Nasdaq Biotechnology Index leapt 14 percent in the first half of the year.
Although many of the companies on the index saw declines in February and March due to coronavirus fears, demand for diagnostic tests and the US Food and Drug Administration's loosening of regulatory pathways to Emergency Use Authorization helped most firms rebound.
2020's biggest gainers so far are NantHealth (+345 percent), GenMark Diagnostics (+206 percent), Quidel (+198 percent), and Meridian Bioscience (+138 percent). Myriad Genetics (-58 percent), Oxford Immunotec (-22 percent), and Becton Dickinson (-12 percent) faced the steepest declines.
NantHealth's share price jump is likely not related to the coronavirus pandemic, as it has not released a diagnostic test for the virus. However, earlier this year it announced it has developed artificial intelligence software to improve lung cancer diagnoses, and it also agreed to sell its connected care assets to Masimo for $47.3 million. The firm also turned its first-ever quarterly profit in Q1 2020. NantHealth's low share price makes it susceptible to changes in the general stock market, so as the broader market trended up, NantHealth received significant benefit.
GenMark Diagnostics, however, can credit its leap in share price to its SARS-CoV-2 diagnostic tests. The company's first quarter revenues increased 80 percent after its ePlex SARS-CoV-2 test received EUA from the FDA in March. The test drove placements of the firm's ePlex instruments and contributed 5 percent to overall ePlex revenue during the quarter, the company said on its earnings call. In addition, GenMark received a $749,000 grant from the US Department of Health and Human Services to develop a diagnostic panel incorporating a SARS-CoV-2 viral target in its respiratory pathogen panel, which the firm launched in June.
Quidel's significant increase is also due to the success of its coronavirus offerings. In March the firm's RT-qPCR test received EUA from the FDA and CE marking, and later in the month the EUA was expanded to allow the test to run on additional thermocyclers and use more types of sample specimens. In May, the company received EUA for its SARS-CoV-2 rapid point-of-care antigen test, which was the first, and so far only, protein-based antigen test to receive EUA. Later that month the firm also received EUA and CE marking for its SARS-CoV-2 assay that does not require an upfront nucleic acid extraction step. Continuing the positive news in June, Quidel received $634,643 from HHS to develop a four-analyte antigen test detecting SARS-CoV-2, respiratory syncytial virus, influenza A, and influenza B.
Meridian Bioscience's positive growth has partially been driven by high demand for its molecular products, specifically the SARS-CoV-2 detection reagents that are being used in many companies' diagnostic assays. This demand helped lead to a 14 percent revenue increase in its fiscal second quarter and allowed the company to raise its full year guidance. Unrelated to the coronavirus, the firm also announced its $49 million acquisition of Exalenz Bioscience, bringing breath test platforms for infectious disease detection into Meridian's portfolio. Earlier in the year, Meridian received FDA clearance for its Curian analyzer and Curian HpSA assay to detect Helicobacter pylori antigens.
Myriad Genetics has had a bumpy first half of the year, withdrawing its FY2020 financial guidance due to the coronavirus pandemic and decreasing test volumes. As a result, Myriad's revenues in its fiscal third quarter declined 24 percent. Although a number of Myriad's companion diagnostic tests have received approval from the FDA, its request to expand coverage of its EndoPredict breast cancer gene expression test was denied by two Medicare Administrative Contractors. A US federal court judge also allowed a whistleblower lawsuit against the company to go ahead, alleging it and its subsidiary Crescendo Bioscience improperly induced ordering of the Vectra test for rheumatoid arthritis.
The reasons for Oxford Immunotec's share price decline are less obvious and likely the result of the broader market's downturn in March and April. Although it announced 18 percent revenue growth in its fourth quarter, the firm later withdrew its full-year guidance due to the decline in testing demand as a result of the SARS-CoV-2 pandemic. Its sales in China were also negatively impacted, leading to a 6 percent revenue decline in the first quarter of 2020. However, its share price did rise in June on reports of a $400 million acquisition offer from a consortium of private equity firms.
Becton Dickinson's share price declined despite receiving EUAs for its rapid hospital SARS-CoV-2 test and its PCR-based SARS-CoV-2 detection kit. The firm also announced in May it had acquired NAT Diagnostics, which will allow BD to expand into the molecular point-of-care space with the Nat Dx technology. Although the firm did see a 1 percent revenue increase in its fiscal second quarter, it noted there had been a negative impact from the pandemic due to a decline in elective hospital procedures and routine diagnostic tests.
