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Biotechnology Headlines

Nation’s First Concomitant DNA Sequencing BRCA and HPV Testing on Pap Cytology Sample Announced by Milford Molecular Diagnostics Laboratory

Now Approved for Patient Care

MILFORD, Conn.--(BUSINESS WIRE)--Sin Hang Lee, MD, director of Milford Molecular Diagnostics Laboratory (MMDL), has been granted a permit by the State of Connecticut to perform the most significant BRCA1 and BRCA2 mutations assay, namely the Ashkenazi Jewish 3 Founder Mutations Analysis, concomitantly with sequencing HPV test on an aliquot of Pap cytology sample. Approval of Dr. Lee’s application was based on his previous research as reported in the media last year (http://www.businesswire.com/news/home/20160211005771/en/Genetic-Screening-Womens-Cancer-Risk-Reduced-200).

“Based on the FDA recommendations regarding your application to offer the Ashkenazi Jewish 3 Founder Mutation Analysis; or as BRCA1 185AG, BRCA1 5382insC and BRCA2 6174delT mutations assay, your submission of additional documentation was received and reviewed.”

Following an extensive review, the Connecticut State Department of Public Health informed Dr. Lee in a notification dated August 17, 2017:

“Based on the FDA recommendations regarding your application to offer the Ashkenazi Jewish 3 Founder Mutation Analysis; or as BRCA1 185AG, BRCA1 5382insC and BRCA2 6174delT mutations assay, your submission of additional documentation was received and reviewed.

It has been determined through consultation with CMS Regional and Central Offices that you be allowed to proceed with patient testing based on the CLIA requirements being met.”

(http://www.dnalymetest.com/images/BRCA_test_approval_letter_2017_8_17.pdf )

“Patients who have questionable results on their BRCA1/BRCA2 and HPV assays, including inconsistent reports between Pap cytology and HPV screens, can now ask their gynecologists for the residue of a tested sample or a new sample in ThinPrep or SurePath vial to send to MMDL for a confirmation test by Sanger sequencing,” said Dr. Lee.

Commercial DNA tests may generate erroneous results, according to Dr. Lee. Referring to the high rate of using inaccurate HPV assays, a common occurrence, he said, “More than 95% of referrals to colposcopy for diagnostic workup are false positive and/or potentially excessive.” (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2746633/ )

“Accurate HPV genotyping based on DNA sequencing may reduce the number of unnecessary harmful colposcopic biopsy procedures,” he added.

Sanger sequencing is the gold standard of all DNA tests. The Food and Drug Administration (FDA) has advised the HPV test kit manufacturers to use DNA sequencing to validate the performance of their medical devices (https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM458179.pdf ).

Dr. Lee’s method can detect HPV DNA residues left in the HPV vaccine that the vaccine manufacturer has missed (https://www.ncbi.nlm.nih.gov/pubmed/23078778), as confirmed by the FDA (https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm276859.htm ). A highly sensitive HPV assay is important to avoid false negatives in cervical cancer screening, according to Dr. Lee.

Dr. Lee also said that MMDL always issues a report with Sanger sequencing electropherograms to validate the wild type, or a homozygous or a heterozygous mutation at the 3 Founder Mutation sites (http://dnalymetest.com/gynecologydnatests.html ).

Women interested in evidence-based precision healthcare may visit www.dnapaptest.com

Contacts

For Milford Molecular Diagnostics
Kevin Moore, 203-788-8497
moorekkvn@gmail.com

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