NONPROFIT, NONPARTISAN PLATFORM OF ACCURATE SCIENCE-BASED SOLUTIONS TO COVID-19

PerkinElmer Inc.

Business Name:
PerkinElmer Inc.
Business Genre:
Business Description:

PerkinElmer is a public company that makes a lot of instruments for a wide variety of life science applications, such as high content screen, mass spectroscopy, chromatography, NGS, diagnostics, and more [1]. PerkinElmer makes kits and instruments for automated isolation of nucleic acids[2]. Their nucleic acid isolation technology uses  M-PVA Magnetic Beads and an electromagnet to purify nucleic acids[3]

City:
Waltham
State:
MA
Country:
USA
Data/Evidence of Effectiveness:
“Reactivity: “BLASTn analysis queries alignments were performed with the SARS-CoV-2 ORF1ab and N oligonucleotide primer and probe sequences with all publicly available nucleic acid sequences for 2019-nCoV in GenBank” • Checked for interfering substances • Cross Reactivity: in silico analysis and wet testing against normal and pathogenic organisms found in the respiratory tract • Clinical Validation: 20 contrived positive oropharyngeal swabs, 20 contrived positive nasopharyngeal swabs, and 94 negative swabs. (100% agreement with expected results) [6] “
Complimentary Products Needed to Perform Test:
“• RNA extraction reagents: The PerkinElmer® Nucleic Acid Extraction Kits (KN0212) and PreNAT II (SY61) • RNA extraction machines: chemagic™ Viral DNA/RNA 300 Kit special H96 or chemagic™ 360 with chemagic™ Rod Head Set 96 • Applied Biosystems TM 7500 Real-Time PCR System • Laboratory supplies: centrifuge, vortex, reagent troughs, 96 well plates and film cover, Magnetic rods disposable tips, PCR strips, [6] “
Setting of Care:
“””Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.”” [6]”
Current Status / Clinical Development Stage / Expected Milestones:
FDA-EUA approved [7]
Funding & Ownership :
public, IPO [1]
Business Model:
PerkinElmer makes kits and instruments for automated isolation of nucleic acids[2].
IP:
They have many patents related to their kits and instruments [1]
History & Origins :
The company was founded in 1931 [1] and have been making products for automated isolation of nucleic acids ever since. [2]
Date EUA Issued:
03/24/2020 [7]
Sources:
[1] https://www.crunchbase.com/organization/perkinelmer [2] https://chemagen.com/ [3] https://chemagen.com/technology/magnetic-separation/ [4]https://chemagen.com/company/perkinelmer-inc/ [5] https://perkinelmer-appliedgenomics.com/home/products/new-coronavirus-2019-ncov-nucleic-acid-detection-kit/ [6] https://www.fda.gov/media/136410/download [7] https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
Organization:
Robert F. Friel [4]
No. Tests Per Day:
24 hours/day / 4 hour runs = 6 runs/day. 94 samples/plate x 6 runs/day = 564 samples/day
Time to Result:
Not stated, but likely 3-4 hours. [6]
Test Sample Type:
“• human oropharyngeal swab and nasopharyngeal swab specimens [6] • Use only synthetic fiber swabs with plastic shafts. “
Technology Overview:
RT-PCR test that uses Taqman primers against N gene (FAM) and ORF1ab (ROX), MS2 (VIC) as an internal control. [6]
Testing Type:
qualitative viral RNA test [5] [6]
Test Category:
RT-PCR
Test Name:
New Coronavirus Nucleic Acid Detection Kit
Clinical Application & Need:
acute infection [5] [6]

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