{"id":502,"date":"2026-10-06T12:10:41","date_gmt":"2026-10-06T10:10:41","guid":{"rendered":"https:\/\/www.gnmhealthcare.com\/?page_id=502"},"modified":"2026-10-07T14:23:21","modified_gmt":"2026-10-07T12:23:21","slug":"the-result-is-in","status":"publish","type":"page","link":"https:\/\/www.gnmhealthcare.com\/?page_id=502","title":{"rendered":"The result is in. The decision isn’t."},"content":{"rendered":"

The science is no longer the question<\/h2>\n

Biomarkers have moved from the margins of drug development into its core architecture.<\/p>\n

In 2025, the FDA approved 16 new personalized medicines, approximately 36% of all newly approved therapeutic molecular entities. Personalized medicines have now accounted for at least one third of new US drug approvals for six consecutive years. In the same year, the FDA cleared or approved 16 significant new or expanded companion diagnostic indications.1<\/a><\/sup><\/p>\n

Oncology shows the shift most clearly. Of 172 novel oncology drugs approved by the FDA between 2012 and 2025, 95 were precision medicines requiring diagnostic testing for optimal patient selection.5<\/a><\/sup><\/p>\n

\n

Exhibit 1<\/p>\n

Precision medicine is now a core share of new approvals<\/p>\n

Share of FDA approvals that are personalized or precision medicines<\/p>\n

\n \n All new therapeutic molecular entities, 2025<\/text>\n 16 personalized medicines<\/text>\n \n \n 36%<\/text><\/p>\n

Novel oncology drugs, 2012 to 2025<\/text>\n 95 of 172 required diagnostic testing for patient selection<\/text>\n \n \n 55%<\/text>\n <\/g>\n <\/svg><\/div>

Sources: Personalized Medicine Coalition (2026); Friends of Cancer Research (2025).<\/figcaption><\/figure>\n

The FDA itself describes biomarkers as tools that support medical product development, improve clinical decision making, and enable companion diagnostics tailored to individual patients.2<\/a><\/sup> The scientific direction is settled.<\/p>\n

Yet the latest real world evidence points to a less comfortable conclusion. The next implementation challenge is no longer simply whether testing happens. It is what happens after the result becomes available.<\/p>\n

Testing is improving, but unevenly<\/h2>\n

Biomarker testing is now embedded in routine oncology care. The 2026 IQVIA Institute report on US precision oncology shows testing rates for established biomarkers approaching saturation in several tumour types, and next generation sequencing (NGS) used for more than 90% of patients with non-small cell lung cancer (NSCLC).3<\/a><\/sup><\/p>\n

\n

Exhibit 2<\/p>\n

Testing for established biomarkers is now routine<\/p>\n

US testing rates for established biomarkers by tumour type, December 2024 (approximate)<\/p>\n

\n \n \n \n \n \n <\/g>\n \n 0%<\/text>25%<\/text>50%<\/text>75%<\/text>100%<\/text>\n <\/g>\n \n Lung (NSCLC)<\/text>\n Breast<\/text>\n Ovarian<\/text>\n Prostate<\/text>\n <\/g>\n \n \n \n \n \n ~95%<\/text>~80%<\/text>~80%<\/text>~75%<\/text>\n <\/g>\n <\/g>\n <\/svg><\/div>
Source: IQVIA Institute, Advancing Precision Oncology (2026).<\/figcaption><\/figure>\n

The same data also expose real variation across tumour types, care settings, and methods. Turnaround time is a clear example. Academic centres returned some breast cancer biomarker results one to two days faster than community hospitals. In NSCLC the pattern reversed: community practices returned PCR results six days faster and NGS results two days faster than academic institutions.3<\/a><\/sup><\/p>\n

No single setting is consistently ahead. That matters, because days spent waiting for a result are days in which a treatment decision may already be taking shape.<\/p>\n

Precision medicine is a chain, not a single decision<\/h2>\n

A biomarker only creates value if every link in the pathway holds. The right patient must be identified, the right test ordered, a viable sample obtained, an interpretable result produced and delivered on time. Then the clinician must interpret it for the patient and turn it into an appropriate treatment decision.<\/p>\n

Progress at one point cannot fully compensate for failure at another. A 95% testing rate means little if the result arrives after therapy has started, or if it is received but not acted upon. The industry has invested heavily in the first five steps. The evidence now suggests the last two deserve equal attention.<\/p>\n

The gap is moving downstream<\/h2>\n

Recent US real world evidence in advanced NSCLC shows that better testing has not, on its own, produced better treatment alignment.<\/p>\n

Diaceutics applied a seven step precision medicine framework to data from more than 35,800 newly diagnosed patients, comparing 2019 with 2023.4<\/a><\/sup> Despite improvements in diagnostic testing, the share of patients not receiving the most appropriate treatment barely moved. What changed was where patients were lost.<\/p>\n

\n

Exhibit 3<\/p>\n

Testing improved, but losses shifted to the treatment decision<\/p>\n

Newly diagnosed advanced NSCLC patients, United States, 2019 vs 2023 (n > 35,800)<\/p>\n

\n \n \n \n 2019<\/text>\n 2023<\/text><\/p>\n

\n \n \n 64.4%<\/text>\n 65.1%<\/text>\n Not receiving the most<\/text>\n appropriate treatment<\/text><\/p>\n

\n \n \n 29.2%<\/text>\n 43.3%<\/text>\n Lost at the treatment<\/text>\n decision stage<\/text><\/p>\n

+14.1 percentage points<\/text>\n <\/g>\n <\/svg><\/div>

Losses at earlier diagnostic stages declined over the same period. Source: Diaceutics, Clinical Practice Gaps Report (2026).<\/figcaption><\/figure>\n

Losses at the treatment decision stage rose by 14 percentage points. Testing improved, but that improvement did not translate proportionately into treatment aligned with biomarker results and guideline recommendations. Physician behaviour reported in the same research helps explain why.<\/p>\n

\n

Exhibit 4<\/p>\n

Many treatment decisions are made before the full picture arrives<\/p>\n

Share of surveyed US oncologists<\/p>\n

\n \n Formed a treatment plan before complete biomarker results were available<\/text>\n \n 86%<\/text><\/p>\n

Consistently waited for results before starting first line therapy<\/text>\n \n 43%<\/text><\/p>\n

Did not consistently act on recommendations in biomarker reports<\/text>\n \n >50%<\/text>\n <\/g>\n <\/svg><\/div>

Source: Diaceutics, Clinical Practice Gaps Report (2026), as reported by News-Medical and SelectScience.<\/figcaption><\/figure>\n

These findings are specific to advanced NSCLC in the United States and should not be generalized automatically to every disease, market, or biomarker.<\/p>\n

They do, however, reveal a strategically important possibility. As diagnostic access improves, the limiting factor may shift from generating the result to creating the conditions in which the result can reliably influence care.<\/p>\n

A biomarker result enters a complex decision system<\/h2>\n

It would be reductive to call this a physician awareness problem. A biomarker led decision is made inside a system of evidence, diagnostic availability, reimbursement, turnaround times, laboratory capability, guidelines, treatment access, local pathways, multidisciplinary coordination, and patient circumstances.<\/p>\n

Earlier IQVIA research identified barriers including inadequate tissue procurement, fragmented continuity of care, inconsistent reimbursement, fragmented testing guidelines, and limited awareness of actionable biomarkers. Its more recent analysis points to three inflection points for biomarker integration:3<\/a><\/sup><\/p>\n