Omicron, Delta or Other Covid Variants Can Be Diagnosed for Any Patient by Sanger Sequencing, Milford Molecular Diagnostics Dr. Sin Hang Lee Announced

MILFORD, Conn.--(BUSINESS WIRE)--Sin Hang Lee, MD, director of Milford Molecular Diagnostics Laboratory announced today that his high complexity CLIA-certified laboratory is offering a diagnostic test directly to patients and their healthcare providers, a test that can determine all known COVID-19 variants of concern and interest, including the Omicron and Delta strains, the most predominant strains in the United States. Milford, Connecticut based Molecular Diagnostics Laboratory is believed to be the only laboratory in the United States offering this test directly to patients and their health care providers.

Dr. Lee explained, “As advised by the Centers for Disease Control and Prevention, now individuals can get a swab and a tube of preserve fluid from their healthcare provider or a testing center to self-collect a nasopharyngeal swab sample, and simply mail the sample to a testing laboratory for SARS-CoV-2 testing.”

For instructions on how to collect and send a sample, see https://www.cdc.gov/coronavirus/2019-ncov/testing/How-To-Collect-NMT-Specimen-for-COVID-19.pdf.

The development and technology of this test is based on an article Dr. Lee recently published in the medical journal, Viruses, titled, “A Routine Sanger Sequencing Target Specific Mutation Assay for SARS-CoV-2 Variants of Concern and Interest,” https://www.mdpi.com/1999-4915/13/12/2386/htm, according to the 3 target mutation sequences listed as follows.

WHO Name Variant	Pango lineage	ACE2 RBD mutations	NTD mutations	N-gene mutations
Alpha	B.1.1.7	N501Y	69del, 70del, 144del	N. A.
Beta	B.1.351	K417N, E484K, N501Y	D80A	N. A.
Gamma	P.1	K417T, E484K, N501Y	D138Y	N. A.
Delta	B.1.617.2	L452R, T478K	T95I, G142D, E156del, F157del, R158G	N. A.
Omicron	B.1.1.529	K417N, N440K, G446S, S477N, T478K, E484A, Q493K, G496S, Q498R, N501Y, Y505H	A67V, Δ69-70, T95I, G142D, Δ143-145	R203K, G204R
Epsilon	B.1.427	L452R		N. A.
Epsilon	B.1.429	L452R	W152C	N. A.
Eta	B.1.525	E484K	A67V, 69del, 70del, 144del	N. A.
Iota	B.1.526	E484K	T95I	N. A.
Kappa	B.1.617.1	L452R, E484Q	G142D, E154K	N. A.
Kappa	B.1.617.3	L452R, E484Q	G142D	N. A.
Lambda	C.37	L452Q, F490S	G75V, T76I	N. A.

“Sanger sequencing is the gold standard used to validate all nucleic acid-based diagnostics,” said Dr. Lee. “Further, the Food and Drug Administration advises that false results of SARS-CoV-2 PCR tests can be investigated using Sanger sequencing.”

Individuals who wish to know the variant of SARS-CoV-2, if present, in their nasopharyngeal samples may find more information at http://www.dnalymetest.com/.