FDAOnayı ile çoklu kanser testi tartışmaları sürüyor; Hong Kong doktorları temkinli yaklaşımını sürdürüyor

Kısaca

FDA panelinin Grail’nin Galleri testine onay yönündeki kararı artık görüldü; Hong Kong’da genişleme çalışmaları sürüyor görünen neden şimdi; sağlık alanında çok sayıda kanseri tek testle tarama fikri dikkat çekiyor piyasa ve iş dünyası için: yatırım ilgisi artabilir, maliyet ve değerlik konuları izlenecek

Ana mesele

MCED kan testiyle çok sayıda kanseri tek bir testte tespit etmek amacıyla regülasyon onayı elde edilmesi süreci başladı

Ne değişti?

ABD onayı sürecinin hız kazanması; Hong Kong’da klinik değerlik hâlâ tartışılıyor

Beni nasıl etkiler?

Okuyucuya etkisi; yatırımcılar MCED teknolojisine odaklı kararlar alabilir, test maliyetleri belirsizliğini koruyor

Ne oldu?

FDA panelinin Grail’nin Galleri testini premarket onayı için önerdiği belirtildi

Neden şimdi?

MCED alanında regülasyonlar ve klinik değerlik tartışmaları güncellendi

Neden önemli?

Regülasyon onayı, yatırım ve klinik uygulama açısından kritik eşik olarak değerlendiriliyor

Kimler etkileniyor?

• Grail (firma)
• Hong Kong tıp kurumları
• halk sağlığı değerlendiricileri
• yatırımcılar

Sektör ve piyasa etkisi

Sağlık teknolojileri ve sigorta sektörlerinde hareketlenme potansiyeli

Riskler

• Klinik değerliğin netleşmemesi
• maliyet-etkinlik tartışmasının süresi
• regülasyon belirsizliği

Takip edilmesi gerekenler

• FDA kararlarının etkisi ve resmi onay süreçleri
• Hong Kong’daki klinik kullanım kapsamı
• maliyet ve sigorta kapsama politikaları
• Grail ve iş ortaklarının küresel genişleme planları

Haberin tamamı

Efforts to detect multiple cancers through a single blood draw are gathering momentum after US regulators endorsed the technology for the first time, although experts say wider adoption in Hong Kong still faces challenges as doctors remain cautious about its clinical value.

In a landmark decision for the emerging field of multi-cancer early detection (MCED) blood tests, a US Food and Drug Administration (FDA) panel on Thursday voted in favour of US company Grail’s “Galleri test”, recommending it for premarket approval.

MCED tests seek to identify signs of cancer in healthy, asymptomatic individuals by analysing abnormal molecules, including circulating tumour DNA (ctDNA), in bodily fluids such as blood and urine.

While the technology remains in its early stage, Hong Kong medical institutions are exploring ways to broaden its use.

Lucence, a Singapore-based provider of MCED blood tests, has expanded its offerings at Hong Kong’s Gleneagles Hospital with a new programme that allows individuals to screen for cancers specific to their risk profiles, the company said at a joint briefing with the hospital on Wednesday, a day before the FDA move.

Gleneagles introduced the original version of the test, known as LucenceInsight, six months ago. The test allows adults to screen for up to 50 types of cancer, including lung, breast and nasopharyngeal cancer.

The technology offered advantages including minimal invasiveness and the potential for earlier detection, Gleneagles Hospital CEO Kenneth Tsang said at the briefing.

MCED tests could become a “valuable addition to existing screening approaches” by helping improve patient outcomes through early treatment, according to an FDA report published on Wednesday before its official vote on the Galleri test.

Wider adoption, however, continues to face challenges as many medical professionals remain sceptical of its efficacy.

“Obviously, it’s very attractive, very appealing,” Anne Lee Wing-mui, vice-chairman of the Hong Kong Anti-Cancer Society, said on the sidelines of the World Cancer Congress in Hong Kong on Thursday.

“But then we need more information, particularly on the cost-effectiveness side. Is it truly working?”

Questions over effectiveness intensified earlier this year. Results from a trial involving 142,000 participants in Britain’s National Health Service showed that the Galleri test failed to meet its primary endpoint of achieving statistically significant reduction in late-stage cancer diagnoses among participants receiving both the test and standard care, compared with those receiving only standard care.

The results, published in February, wiped out nearly half of Grail’s market value.

Lucence said that its LucenceInsight test has a sensitivity rate of 81 per cent and a specificity rate of 99 per cent – respective measures of a test’s ability to correctly identify people with a disease and those without it.

“The biggest problem is actually to convince the doctors. Doctors have been trained to believe in the gold standards,” Gleneagles’ Tsang said.

“That’s why the one biggest barrier right now [that] we’re working together on [tackling] is to educate doctors [about] how this will change their practices.”

Kaynaklar

• South China Morning Post - Business