Medical device filing citing Gynecologic Oncology paper — Orasure Technologies, 2021-08-03
Orasure TechnologiesOrasure TechnologiesNASDAQ OSUR
Filings SEC · Quote Yahoo cited a paper published in Gynecologic Oncology in a regulatory filing with the U.S. Securities and Exchange CommissionU.S. Securities and Exchange Commission
Regulator · Website. The company's manner of writing the paper and the actual scope of the paper were read in order. The stock price movement for one month after the filing was compared to past cases of the same type. This is a retrospective judgment written after knowing the results. The paper was read only up to the abstract.
The disclosure wrote the paper in the press release like this
When a U.S. listed company has something to inform shareholders, the report submitted to the Securities and Exchange Commission is called 8-K. The item number of the document submitted by Orasure Technologies on 2021-08-03 was 2.02 Earnings announcement · 7.01 Reg FD disclosure · 9.01 Financial statements · Attached documents. The company cited a paper published in Gynecologic Oncology in the attached press release. The sentence citing the paper, copied verbatim from the original, is as follows.
The sentence in the press release citing the paper could not be automatically found. Confirm it via the original link. Do not replace it with another paragraph.
What readers see first is where the company placed the paper in the press release. Next is determining whether the paper supports the company's entire claim or only part of it. To answer the latter question, one must read the full paper. This article, which read only the abstract, cannot answer that.
The scope of the paper discussed in the abstract is limited to this extent.
The paper title is Clinical and analytical evaluation of the RealTime High Risk HPV assay in Colli-Pee collected first-void urine using the VALHUDES protocol and it was published in Gynecologic Oncology on 2021-06-23. The authors' affiliations are University of Antwerp · Infectious Diseases Institute · Sciensano (Belgium) · Ghent University. The summary published at the beginning of the paper is called abstract. This article read only up to there. This paragraph was rewritten by a person after filtering a draft written by a machine reading the abstract by numerical comparison, so it is of a different grade from a full-text reading and official judgment.
The abstract of this paper is not publicly available, so a summary of the main text could not be attached. From the title alone, it is possible to discern that the study examines how well high-risk human papillomavirus testing matches in specimens collected using a device that captures the first portion of urine. The issue at stake is whether cervical cancer screening can be replaced by urine. How many individuals were compared, and what criteria were used to measure accuracy remain in the main text beyond the abstract.
What the abstract does not answer remains in the full text and appendices. This article leaves gaps as they are. Readers are to judge for themselves which sentences in the abstract correspond to the excerpts cited by the company, by comparing the two citations above.
A month later, the stock price was within the middle half of the sample.
The remaining return after subtracting the portion attributable to market-wide movements is called excess return. Dates are counted only on days when the stock market is open, referred to as trading days. In terms of a calendar, 20 trading days amount to roughly a month. The excess return on the day of the regulatory filing and for the following month are presented in the table below.
| Period | Excess return relative to the market | Meaning |
|---|---|---|
| 5 trading days before the filing | +12.2% | The extent of movement before the filing |
| On the filing date | +4.9% | On the filing date or the first trading day thereafter |
| Cumulative over +1 to +5 trading days | −5.0% | One week |
| Cumulative over +1 to +20 trading days | −13.7% | One month |
A bundle of past cases of the same type is called a sample. The position counted from the bottom is expressed as a percentile. The one-month excess return of -13.7% in this case is within the bottom 37% of the 142 samples, placing it in the lower half.
| Sample scale (20 trading days) | Tenth from the bottom | Fourth from the bottom | Median | Top 25% | Top 10% | This case |
|---|---|---|---|---|---|---|
| Excess return | −31.9% | −20.1% | −6.9% | +5.5% | +19.5% | −13.7% |
Half of the sample falls between the two central marks on the chart. One checks the chart to see whether this case lies within or outside the range. The sample collects cases where U.S.-listed companies cited papers in 8-K filings over the past decade. The company itself is excluded from the sample. The numbers listed here are past facts, not rules applicable to future cases.
After the filing, the company issued such documents.
Three 8-K filings issued by the company after the filing date are listed by item number only. In 8-K filings without titles, the item number indicates the type of content. Whether it was an earnings announcement or a contract can be determined by the number. The specific event is read in the original text via each link.
- 2021-08-13 8-K Item 5.02 — Changes in Directors and Executive Officers
- 2021-09-02 8-K Items 5.02, 7.01, 9.01 — Changes in Officers and Directors — Reg FD Disclosure — Financial Statements and Exhibits
- 2021-09-08 8-K Item 7.01, 9.01 — Reg FD Disclosure · Financial Statements · Exhibits
What this article does not answer
This article, based on abstracts alone, cannot answer what methods the paper used, what it reviewed, or how far it went. How many times the cited paper was referenced afterward can be verified again via OpenAlexOpenAlex
Data source · Website citation counts. What will be checked next is whether the company's next 8-K filing cites the same paper again.
Glossary
- 8-K
- A voluntary report submitted to the Securities and Exchange Commission when a U.S. listed company has something to inform shareholders. Types are indicated by item numbers such as earnings, contracts, and executive changes. All events in this article come from this document.
- Excess return
- The remainder after subtracting the overall market return from the stock return. It is used to see the movement of the company alone by removing the part where the market as a whole rises or falls.
- Trading day
- A date counting only the days the stock market is open. Since weekends and holidays are excluded, 20 trading days are approximately one calendar month.
- Sample and percentile
- A bundle of past cases of the same type is a sample, and the position from the bottom within it is expressed as a percentile. A percentile of 10 means that nine out of ten cases performed better than this case.
- Abstract
- A summary placed at the beginning of a paper. The author writes in a few sentences what was done, how it was done, and what results were obtained. Without reading the full text, one cannot know the details and limitations of the method.