23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia

Retrieved 2026-10-29 · the fields above are FDA's; the statement below was copied from the decision document on that day.

What FDA granted it for

The Indications for Use statement, verbatim, from the decision document.

The 23andMe Personal Genome Service (PGS) Test uses qualitative genotyping to detect the following clinically relevant variants in genomic DNA isolated from human saliva collected from individuals ≥18 years with the Oragene Dx model OGD-500.001 for the purpose of reporting and interpreting Genetic Health Risks (GHR): The 23andMe PGS Genetic Health Risk Report for Hereditary Thrombophilia is indicated for reporting of the Factor V Leiden variant in the F5 gene, and the Prothrombin G20210A variant in the F2 gene. This report describes if a person has variants associated with a higher risk of developing harmful blood clots, but it does not describe a person's overall risk of developing harmful blood clots. This test is most relevant for people of European descent. The 23andMe PGS Genetic Health Risk Report for Alpha-1 Antitrypsin Deficiency is indicated for reporting of the PI*Z and PI*S variants in the SERPINA1 gene. This report describes if a person has variants associated with AAT deficiency and a higher risk for lung or liver disease, but it does not describe a person's overall risk of developing lung or liver disease. This test is most relevant for people of European descent. 4 The 23andMe PGS Genetic Health Risk Report for Late-onset Alzheimer’s Disease is indicated for reporting of the ε4 variant in the APOE gene. The report describes if a person's genetic result is associated with an increased risk of developing Late-onset Alzheimer’s Disease, but it does not describe […]

The product code's definition, from FDA's classification record. A qualitative in vitro molecular test that detects variants in genomic DNA isolated from human specimens. This assessment system provides users with a genetic health risk assessment of developing a disease and is intended to inform users of lifestyle choices and/or encourage conversations with a healthcare professional. This assessment system is for over-the-counter use. This device does not determine the person’s overall risk of developing a disease.

What the statement says

Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.

• Mentionsdetection or identification of findings
• Mentionsadult patients

Adverse-event reports in MAUDE, by product code

As of 2026-10-29, MAUDE held 7 reports filed against devices carrying product code PTA. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:

13 April 2026 · Malfunction · Conquest · BARD PERIPHERAL VASCULAR, INC. · report 2020394-2026-00920

ON (B)(6) 2026, A PATIENT UNDERWENT A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE USING THE CONQUEST BALLOON CATHETER. DURING THE PROCEDURE, IT WAS REPORTED THAT THE BALLOON CATHETER ALLEGEDLY UNABLE TO DEFLATE. IT WAS FURTHER REPORTED THAT THERE WAS AN ATTEMPT TO BURST THE BALLOON USING THE BARD PRESTO INFLATOR, BUT IT DID NOT AFFECT THE BALLOON; HOWEVER, PART OF THE CATHETER BURST UNDER PRESSURE. BALLOON WAS INTACT. THERE WAS NO REPORTED PATIENT INJURY.

9 February 2026 · Malfunction · HIGH THROUGHPUT DNA SEQUENCE ANALYZER · SEQUENCING INC. · report MW5183582

ADDITIONAL INFORMATION RECEIVED ON 03/11/2026 FOR REPORT MW5183582 TO UPDATE MANUFACTURER.

9 August 2024 · Malfunction · GENOME DISCOVERY WGS BUNDLE · SEQUENCING INC. · report MW5158298

HELLO. I AM A PHD CLINICAL GENETICS AND GENOMICS EXPERT. A GENETIC COUNSELOR JUST MADE ME AWARE OF AN IVD OFFERED AS AN LDT THAT SHE SAW ADVERTISED ONLINE THAT IS HIGHLY SUSPECT FOR BOTH FALSE POSITIVES AND FALSE NEGATIVES. IT'S A WHOLE GENOME SEQUENCING TEST CALLED "SEQUENCING.COM", SEE HTTPS://SEQUENCING.COM/. IT REPORTS ON HEALTH, RARE DISEASE, WELLNESS, AND FAMILY FINDINGS. PAGE HTTPS://SEQUENCING.COM/RARE-DISEASE-DNA-ANALYSIS-LIST?PAGE=1 LISTS THOUSANDS OF GENETIC CONDITIONS AND SAYS, […]

29 April 2020 · Malfunction · NUTRIGENOMICS AND LIFESTYLE / FITNESS / WELLNESS AND LIFESTYLE REPORTS · UNK · report MW5094322

ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 06/02/2020 FOR REPORT MW5094322. I NOTICED THAT THE SUBMISSION FOR MW5094322 DIDN'T MENTION "(B)(6)" ANYWHERE. I THINK THIS IS IMPORTANT, GIVEN THE SEVERITY OF THE PROBLEMS. SO, TO TRY AND MAKE IT MORE CLEAR AND MAKE SURE THAT THE COMPANY NAME IS INCLUDED IN THE REPORT, I AM RE-SUBMITTING SEPARATE ENTRIES FOR EACH REPORT. I SUBMITTED FILES FOR RE-ANALYSIS FROM (B)(6) FOR 2 DIFFERENT TYPES OF EXPORTED DATA: 23ANDME GENOTYPES ((B)(6)) AND […]

31 March 2020 · Malfunction · METABOLISM+ TEST · UNK · report MW5094002

I PURCHASED THE FOOD SENSITIVITY TEST+ AND METABOLISM TEST+ FROM EVERLYWELL. WHILE I REALIZE THE LINK WILL BE REMOVED FROM THE MAUDE REPORT, HERE IS THE ADDITIONAL INFORMATION (INCLUDING THE PDF REPORTS) FOR THE FDA: (B)(4). ESSENTIALLY, I ENCOUNTERED THE FOLLOWING ISSUES: I THINK THAT THERE WAS AT LEAST ONE TECHNICAL ISSUE WITH THE BLOOD TESTS: I HAVE TSH TESTS FROM BLOOD DRAWS, AND THE EVERLYWELL RESULT WAS A BIT HIGHER THAN THE BLOOD DRAWS FROM QUEST (EVEN THOUGH I THINK IT WAS STILL WITHIN […]

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