Cepheid Inc

Cepheid is an American molecular diagnostics company. Its systems automate traditional nucleic acid tests (tests for specific sequences of DNA or RNA). The tests can be used to identify and analyze pathogens and genetic disorders. Cepheid sells clinical tests for healthcare-associated infections, infectious diseases, sexual health, oncology and genetics.[3]

Cepheid Inc.
Subsidiary
Industry
FoundedMarch 1996 (1996-03)
HeadquartersSunnyvale, California, US
Key people
  • John L. Bishop
  • (Chairman & CEO)
  • Warren Kocmond
  • (President & COO)
  • Dr. David Persing
  • (Chief Medical Officer)
RevenueUS$531.08 million (August 2016)
Number of employees
1,700 (2016)
ParentDanaher Corporation
Websitecepheid.com
Footnotes / references
[1][2]

The cartridges used in Cepheid's testing machines are single-use and must be bought from the manufacturer. The company has been accused of profiteering, with a Doctors without Borders analysis claiming that Cephid is charging over six times the cost of production for COVID-19 test cartridges sold to developing countries.[4][5][6]

Founding and corporate status

The company went public in 2000.[7] Cepheid was founded in March 1996 by Thomas Gutshall, Bill McMillan, Dr. Kurt Petersen, Dr. Greg Kovacs, Steven Young and Dr. Allen Northrup. The initial public offering was June 21, 2000 at US$6 per share. Cepheid stock was listed on the Nasdaq under the ticker symbol CPHD until it was acquired by Danaher in 2016.[8]

The company's first CEO was Tom Gutshall, who held the position from 1996 to 2002.[9] In April 2002, John L. Bishop was appointed CEO.[1]

In August 2016, the company had a market capitalization of US$2.66 billion.[10]

In late 2016, Danaher Corp. bought Cepheid for US$4 billion,[11][12][13] citing a large base of already-installed test instruments, and a wide menu of tests that fit in them.[14]

Cepheid is headquartered in Sunnyvale, California.[15]

System
FISH testing, a standard techniqure for identifying pathogens, is done automatically by Cepehid's GeneXpert test systems

Cepehid owns the GeneXpert rapid molecular diagnostic system, its main product.[3] The system was developed in the 1990s; the design remained substantially the same from the turn of the century to 2020.[7] Similar tests have subsequently been developed by Abbott and Roche.[7]

The GeneXpert system identifies organisms from their DNA.[7] It extracts genetic material from a sample and, in the case of RNA viruses, it converts the RNA into DNA first.[16] The GeneXpert test is basically an automated version of standard real-time PCR (polymerase chain reaction) amplification and detection.[7]

Each sample to be tested is added to a single-use GeneXpert cartridge, sold by Cepheid; after this, the tests are self-contained[16] and fully-automated.[7] The cartridge contains a series of injection-moulded plastic chambers, which hold the chemicals and the sample.[7] To run the test, multiple cartridges are loaded into a desktop machine (also made by Cepheid, but reusable).[16] The sample and chemicals are moved into the test chambers using microfluidics: there is a rotary valve in the center, and some small plungers; the plungers push the sample into the valve, the valve rotates to a new position, and the sample is them pulled out into a new chamber. The machine provides the temperature cycling needed for the PCR (much like a programmable oven). This makes many copies of DNA matching the sample (amplification). Finally, the presences or absence of the pathogen is detected using FISH probes. These are short sections of DNA which have been made to attach to a fluorescent molecule. If the DNA from the sample matches the DNA of the FISH probes, the two bind, and the sample fluoresces. An optical system detects the glow, or its absence.[7] A test for a new disease can be made by simply swapping in a FISH probe that matches the sequence of the new disease.

History

The company was thrust into the limelight after the 2001 anthrax attacks as one of the few companies producing rapid, accurate biodetection field units based on DNA analysis. Cepheid had developed unique improvements on Lawrence Livermore National Laboratory's fast-cycling technique for preparing DNA samples. US federal agencies used Cepheid machines to detect the spreading anthrax contamination and identify its possible sources.[17][7] In 2003, the company put a temporary hold on some healthcare development to work with defense contractor, Northrop Grumman, on a US federal government contract to install anthrax detection systems at US Post Office sites nationwide.[18]

Cepheid won the 2006 Industrial Design Excellence Awards for its product, Reagent Bead Dispenser.[19]

The first clinical application for the GeneXpert System was introduced in 2006 with the US FDA clearance of XpertGBS, a rapid molecular diagnostic test for Group B Streptococcus in expectant women.[20] That same year, XpertGBS was categorized by the FDA as "Moderate Complexity"[21] under the Clinical Laboratory Improvement Amendments (CLIA). It was the first amplified molecular diagnostic test using real-time PCR to receive this categorization.[22] This allowed the test to be performed by the over 27,000 institutions registered for CLIA Moderate Complexity in addition to the approximately 7,000 institutions registered for High Complexity tests.

In 2012, Cepheid won a contract with the US Department of Veterans Affairs for its MRSA reagent test kits.[23]

As of March 31, 2014, Cepheid markets 14 US FDA-cleared clinical in vitro diagnostic (IVD) tests in the US and 16 IVD tests internationally and has placed 6,012 GeneXpert systems globally.[24] As of March 2020, there are over 23 000 GeneXpert machines globally, 7000 - 10,000 of them in Africa, Latin America and South-East Asia, with over a hundred in some African countries, due to long-term investment in tuberculosis-testing infrastructure by The Global Fund, among others.[25]

During the COVID-19 pandemic, Cepheid announced a partnership with Sherlock Biosciences in February 2020 to begin development of a CRISPR-based diagnostic test for the SARS-CoV-2 (then called "2019-nCov") virus,[26] to run on the same machines as Cepheid's 20-year-old GeneXpert tests, as there were machines already installed in hospitals.[7] In March 2020, the company announced a rapid diagnostic test for SARS-CoV-2; the US FDA granted an emergency use authorization for the test.[27] The diagnostic is designed to run on any of the (over 23,000) existing Cepheid GeneXpert machines worldwide, with the standard 45 minute detection time.[28]

Pricing controversy

There has been controversy around Cepheid's test-cartridge pricing. Cepheid announced that they would charge US$19.80 per COVID-19 test in developing countries[4][29] (prices are higher in middle-income countries; for instance, GeneXpert TB tests cost $55-$82 per cartridge in Indonesia[29]). Doctors without borders stated that that price was not affordable in countries where people live on less than two dollars a day.[4][29] They estimated[5] that the cost to Cepheid of providing the test is as low as $3, and called the offered price profiteering, asking that Cepheid make a more moderate profit by selling the tests for US$5 each.[29][4][6]

The Treatment Action Group (TAG) seconded this request, saying that the development of the tests, and their purchase and global deployment, has been done with public funds, while the owners of Cepeid made profits of $3 billion in 2019. They requested the same price reduction for all the tests using the same technique, including HIV, tuberculosis, and Hepatitis C, as the costs are similar regardless of the disease (see above).[30] They pointed out that the cartridges for testing for COVID-19 were twice the price of nearly-identical cartridges for tuberculosis, as of March 2020.[16] The International Union Against Tuberculosis and Lung Disease also gave public support.[25][31] Some dozens of organizations worldwide had joined the “Time for $5” campaign as of October 2019.[32][30]

gollark: Between contacts who are using Signal.
gollark: Signal is end to end encrypted isn't it?
gollark: With end to end encryption, the server cannot see your messages, so you don't need to trust it for anything but metadata, which is admittedly somewhat bee.
gollark: You can compile the app yourself?
gollark: No, Signal is open source so you can check the client code.

See also

References
  1. "John L Bishop: Cepehid Profile & Biography". Bloomberg News. Retrieved March 22, 2020.
  2. "CPHD Key Statistics - Cepheid Financial Ratios - MarketWatch". MarketWatch. Archived from the original on August 3, 2016.
  3. "Cepheid (CPHD.O) Company Profile". Reuters. Archived from the original on March 4, 2016. Retrieved March 22, 2020.
  4. "No profiteering on COVID-19 drugs and vaccines, says MSF". Médecins Sans Frontières (MSF) International.
  5. "Time for $5: GeneXpert diagnostic tests". Médecins Sans Frontières Access Campaign. Technical Brief.
  6. Ren, Grace (March 24, 2020). "Médecins Sans Frontières Announces Campaign For $5 COVID-19 Test On 'GeneXpert' TB Platform". Health Policy Watch.
  7. Perry, Tekla. "A Rapid Test for Covid-19 Arrives Via a 20-year-old Technology Already in Many Hospitals". IEEE Spectrum: Technology, Engineering, and Science News. IEEE.
  8. "Archived copy". Archived from the original on May 29, 2014. Retrieved May 29, 2014.CS1 maint: archived copy as title (link)
  9. Editorial, Reuters. "Company Search Results". Reuters. Retrieved April 17, 2017.
  10. "CPHD Stock Quote - Cepheid Stock Price Today (CPHD:NASDAQ) - MarketWatch". MarketWatch. August 16, 2016. Archived from the original on August 17, 2016.
  11. Grover, Natalie (September 6, 2016). "Danaher to buy Cepheid in $4 billion deal to expand in diagnostics". Reuters.
  12. Hufford, Austen (September 6, 2016). "Danaher to Buy Diagnostics Company Cepheid for $4 Billion". Wall Street Journal.
  13. Darie, Tatiana. "Danaher Buys Cepheid for $4 Billion in First Deal Since Spinoff". www.bloomberg.com.
  14. Enriquez, Jof. "Danaher Buys Molecular Diagnostics Firm Cepheid For 4 Billion". www.meddeviceonline.com.
  15. "Sunnyvale company wins FDA approval for first rapid coronavirus test with 45-minute detection time". The Mercury News. Reuters. March 21, 2020.
  16. Brits, Elsabé (March 7, 2020). "Covid-19: How South Africa will test for the virus". www.msn.com.
  17. "Biotech firms turn to antiterrorism efforts / Cepheid makes anthrax detectors". SFGate. Retrieved April 17, 2017.
  18. "Biotech firms turn to antiterrorism efforts / Cepheid makes anthrax detectors". SFGate. Retrieved March 22, 2020.
  19. "2006 Industrial Design Excellence Awards". Markets.financialcontent.com. July 5, 2006. Archived from the original on March 9, 2014. Retrieved March 9, 2014.
  20. "Cepheid's Xpert GBS(TM) Test Receives 510(k) Clearance From FDA". Archived from the original on May 31, 2014. Retrieved May 30, 2014.
  21. "Test Complexities". wwwn.cdc.gov. Retrieved April 17, 2017.
  22. "Cepheid Xpert GBS(TM) Test Categorized as 'Moderate Complexity'. - Free Online Library". www.thefreelibrary.com. Retrieved April 17, 2017.
  23. "Contract Award: Cepheid Wins Federal Contract for "MRSA Reagent". Highbeam.com. April 16, 2012. Archived from the original on June 11, 2014. Retrieved March 9, 2014.
  24. "Archived copy" (PDF). Archived from the original (PDF) on May 31, 2014. Retrieved May 30, 2014.CS1 maint: archived copy as title (link)
  25. Fletcher, Elaine; Vijay, Svĕt (March 23, 2020). "New COVID-19 Rapid Diagnostic Approved On 'GeneXpert' TB Platform; Could Pave Way For More Testing In Low- & Middle-Income Countries". HealthPolicy-Watch.org. Archived from the original on April 4, 2020.
  26. Hale, Chris (February 28, 2020). "Sherlock Bio, Cepheid pair up to develop CRISPR diagnostics for coronavirus and more". FierceBiotech.com. Archived from the original on March 6, 2020.
  27. "Sunnyvale company wins FDA approval for first rapid coronavirus test with 45-minute detection time". EastBayTimes.com. March 21, 2020. Archived from the original on March 22, 2020.
  28. Singh, Kanishka (March 22, 2020). "U.S. FDA approves first rapid coronavirus test with 45 minutes detection time". Reuters. Retrieved March 22, 2020.
  29. "Indonesian government could use TB test kits for COVID-19, doctor says". The Jakarta Post.
  30. "Treatment Action Group Statement on the High Price of Cepheid's Xpert Test for COVID-19". Treatment Action Group.
  31. "World TB Day statement on CEPHEID rapid testing for COVID-19". The Union.
  32. "OPEN LETTER: Time to Lower the Price of Xpert Cartridges to US$ 5" (PDF). TBOnline. October 21, 2019. Retrieved May 2, 2020.
This article is issued from Wikipedia. The text is licensed under Creative Commons - Attribution - Sharealike. Additional terms may apply for the media files.