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360Dx Index Follows Larger Market Trends, Drops 4 Percent in November

NEW YORK – The 360Dx Index followed the lead of the wider economy in November, dropping 4 percent month over month.

The decline reflected downturns in the broader economic markets, which were spooked by the uncertainty brought on by the SARS-CoV-2 Omicron variant at the end of the month. The Dow Jones Industrial Average fell nearly 4 percent month over month from October, while the Nasdaq was flat and the Nasdaq Biotech Index fell 4 percent.

The 360Dx Index's largest gainers last month were Fulgent Genetics (+13 percent), Quidel (+11 percent), and Burning Rock Biotech (+10 percent). The decliners were led by Invitae (-36 percent), Genetron Health (-34 percent), and Castle Biosciences (-34 percent).

Fulgent's growth was likely due to its announcement that its third quarter revenues more than doubled year over year to $227.9 million, driven by COVID-19 sales, and the resulting announcement that the company would be raising its 2021 full-year guidance from $800 million to $930 million.

With the money from its COVID-19 test business, the company plans to branch further into oncology testing and expand its pharmaceutical and clinical research support services business, Fulgent leadership said on a conference call to discuss its earnings.

Quidel also saw a boost from its earnings announcement last month, with third quarter revenues up 7 percent from the previous year to $509.7 million and beating the consensus Wall Street estimate. The growth was led by increased sales of COVID-19 tests, particularly its QuickVue At-Home OTC COVID-19 test, the company said.

Burning Rock Biotech had two key pieces of news in November, namely its earnings results and a companion diagnostics deal. The company announced that its third quarter revenues rose 2 percent year over year, thanks to increasing in-hospital test revenue.

Later in the month, Burning Rock said it has entered a strategic partnership with Merck to develop a companion diagnostic for the MET inhibitor tepotinib (Tepmetko) in the mainland China market using Burning Rock's OncoCompass Target panel.

Although Invitae announced revenue increases of 66 percent during its third quarter earnings call, the firm saw a significant decline in share price throughout November. Part of that drop is likely due to a lawsuit filed by the company against Natera in the US District Court for the District of Delaware alleging that Natera infringes two of its patents covering DNA sequence assembly.

The Invitae patents at issue were granted in October and comprise novel techniques to improve the performance of DNA sequencing technology, the lawsuit said.

The company's earnings results also missed analyst estimates despite their increase year over year, and the firm lowered its full-year revenue guidance by $25 million, to between $450 million and $475 million, due to potential COVID-19 impacts. JP Morgan analyst Tycho Peterson wrote in a note that, despite the disappointing results, "increasing payor collection rates and the continued [noninvasive prenatal testing] ramp provide support for future growth."

Genetron's share price decline came in spite of multiple positive developments for the company during November. At the beginning of the month, the company received CE marking for its Onco PanScan genomic profiling test for cancer, which uses next-generation sequencing and hybridization capture to detect cancer-linked mutations and variants.

The Chinese firm also announced a partnership with NeoGenomics last month to assist with drug developers' clinical trials. The two companies will use their technology platforms and product pipelines to help partners synchronize global clinical drug trials and companion diagnostics development, Genetron said.

Earlier this week, as the month came to a close, Genetron reported that its third quarter revenues had risen 36 percent compared to a year ago, largely thanks to increases in liquid biopsy diagnosis and monitoring testing and laboratory developed testing services. It also saw revenue from in vitro diagnostic product sales jump 71 percent due to sales of its Genetron S5 instrument and lung cancer test.

Genetron also announced a collaboration agreement with AstraZeneca R&D in China to jointly develop NGS-based tumor-informed minimal residual disease tests for various solid tumor types.

The only news from Castle Bio last month was its announcement that its third quarter revenues rose 54 percent year over year as a result of increased gene expression profile test volume. Despite beating Wall Street estimates, Castle Bio didn't increase its full-year revenue guidance, which Canaccord Genuity analyst Kyle Mikson called an "appropriate decision" in a note, although he said that the decision could prove conservative.

360Dx Index        
Company Ticker 30-Nov-21 29-Oct-21 Percent Change
Abbott ABT 125.77 128.89 -2.42
Accelerate Diagnostics AXDX 5.00 5.90 -15.25
Adaptive Biotechnologies ADPT 26.09 33.41 -21.91
Becton Dickinson BDX 237.14 239.59 -1.02
Bio-Rad BIO 753.20 794.68 -5.22
Bio-Techne* TECH 472.03 523.65 -9.86
Burning Rock Biotech BNR 15.46 14.09 9.72
CareDx CDNA 43.14 51.00 -15.41
Castle Biosciences CSTL 41.33 62.35 -33.71
Danaher DHR 321.64 311.77 3.17
Exact Sciences EXAS 85.37 95.22 -10.34
Fulgent Genetics FLGT 93.52 82.92 12.78
Genetron Holdings GTH 9.04 13.77 -34.35
Guardant Health GH 105.12 116.79 -9.99
Hologic HOLX 74.73 73.31 1.94
Invitae NVTA 17.00 26.50 -35.85
Labcorp LH 285.33 287.02 -0.59
Meridian Bioscience VIVO 19.91 18.81 5.85
Myriad Genetics MYGN 25.86 30.77 -15.96
Natera NTRA 91.46 114.57 -20.17
NeoGenomics NEO 34.26 46.00 -25.52
Opko Health OPK 3.93 3.79 3.69
PerkinElmer PKI 182.16 176.89 2.98
Qiagen QGEN 55.13 55.76 -1.13
Quest Diagnostics DGX 148.68 146.78 1.29
Quidel QDEL 147.56 132.77 11.14
Quotient QTNT 2.12 2.53 -16.21
Thermo Fisher Scientific TMO 636.30 633.07 0.51
Veracyte VCYT 41.48 47.88 -13.37
360Dx Index Average   141.37 147.26 -4.00
*Bio-Techne paid a dividend of $.32 per share on Nov. 10.