推动产前基因检测采用的关键因素

Dx Trends: Prenatal GeneticsProprietary Survey of 169Ob-Gyns and MFMs Please refer to important disclosures on pages 19 and 20. Analyst certification is on page 19.William Blair or an affiliate does and seeks to do business with companies covered in its research reports. As aresult, investors should be aware that the firm may have a conflict of interest that could affect the objectivity of thisreport. This report is not intended to provide personal investment advice. The opinions and recommendations here- Portfolio Manager’s Summary..........................................................................................3Survey Methodology and Respondent Profile..................................................................5Ordering Behavior: What Drives Decision-Making..........................................................6Prenatal Genetics: State of the Union...............................................................................8 Introduction to Prenatal GeneticsAbout 15 years ago, the first cell-free DNA non-invasive prenatal test (NIPT) was launched in Down’s syndrome), these tests have seen increased adoption as organizations like the AmericanCollege of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine(SMFM) have expanded guidelines: first recommending NIPT for high-risk pregnancies, and nowrecommending prenatal genetic screening (like cell-free DNA screening) to be discussed and of- Carrier screening for inherited conditions (e.g., cystic fibrosis and sickle cell disease) has also in-creased in adoption. ACOG now recommends that “information about carrier screening shouldbe provided to every pregnant woman” and “if an individual is found to be a carrier for a specificcondition, the patient’s reproductive partner should be offered testing in order to receive informed testing uses cell-free technology to assess not just the risk of chromosomal conditions (aneuploidytesting) but also the risk of single-gene disorders (like cystic fibrosis and sickle cell disease). Com-panies like BillionToOne’s UNITY Fetal Risk Screen and Natera’s Fetal Focus test are moving thisfield forward—quickly. Currently, the U.S. market for aneuploidy and carrier screening testing exceeds $2.5 billion. Weestimate that market leader Natera holds over a 50% share, while BillionToOne has close to 20%—impressive given its commercial launch in 2019 and smaller salesforce. Other providers includeLabcorp, Quest Diagnostics, and Myriad Genetics. Our Proprietary ResearchFrom early December through early January, we conducted an extensive survey of 169 U.S. obste- trician-gynecologists (ob-gyns) and maternal-fetal medicine specialists (MFMs). We asked ques-tions on practice trends, including test selection criteria, lab usage, anticipated changes in order-ing, and interest in new tests such as those that assess fetal risk for inherited conditions withoutpaternal testing. This survey expanded on the research we conducted for ourrecent initiation of Key survey findings among these respondents: the next year, taking share from Labcorp, Quest, and Myriad. This is due to these two playersalready having strong awareness and share, as well as both being seen as moving the field for-ward by offering innovative solutions that can remove some friction from the testing workflow. 2.BillionToOne is expected to see the most increases in utilization on a provider level, with 28%of providers in this survey indicating expected increases in orders within the next year. 40%of this same group noted they expect declines in their Labcorp prenatal genetics orders over 3.Natera should be able to at least maintain its share levels over the coming year—72% of cur-rent users in this survey do not anticipate changing ordering patterns in the next year and only7% said they plan to decrease ordering patterns. 5.Physicians find it difficult to obtain paternal testing samples when the mother has a positive car-rier screening result. Fifty-one percent of respondents noted it was at least somewhat difficult toobtain paternal genetic testing and one in five said it would be “game changing” to have the ability 7.Awareness of Fetal Focus at the time of this survey was very low (45% of respondents werenot familiar at all). Utilization is still expected to increase given the heavy Natera share of thisgroup, but respondents that expect to increase utilization of Fetal Focus also anticipate main- 8.What we also found interesting was what we did not hear: any concerns over false negativeresults when using UNITY. Stock Thoughts for Covered Companies: BillionToOne:These survey results highlight a view we had at the time of our initiation— Billion- ToOne has a long growth runway ahead of it for durable and profitable growth. There is demandfor the type of tests it offers, respondents are becoming increasingly familiar with UNITY, productfeedback is strong, and this is being done when only roughly 40% of respondents hav