最近，位于美國圣迭戈的Illumina公司宣稱將成立一家名為Grail的新公司，其A輪融資已經超過1億美元。Illumina將持有多數股權，而重要投資者還包括微軟創始人比爾?蓋茨和亞馬遜創始人杰夫?貝佐斯，以及ARCH Venture Partners和Sutter Hill Ventures等風投公司。

這究竟是一家什么企業？怎么會引發兩位科技大佬的垂青呢？

基因序列測定公司Illumina正在追逐癌癥檢測領域的下一個巨大突破。這家公司正致力于研發一種通用的血液檢測措施，用于檢測那些沒有癥狀的早期癌癥患者。

Grail公司將使用Illumina的DNA序列測定技術來掃描源自腫瘤，在血液中循環的癌癥基因，以期檢測出許多種新形成的癌癥，從而幫助早期癌癥患者盡快獲得治療，提高存活率。

Cowen & Co公司預計，到2020年，每年用于癌癥篩選DNA血液檢測的花費將超過100億美元。有幾家公司正在研發這種液體活組織檢查，主要用于已被診斷出癌癥的患者。

專家表示，讓DNA血液檢測成為常規癌癥檢查的一部分，還需要進行大量的臨床試驗，才能獲得足夠的證據。在沒有進行類似試驗的情況下，直銷檢驗公司Pathway Genomics去年提供了一項針對健康人的DNA血液檢測項目。作為一家更大的公司，Illumina打算提供相關的檢測證據。

Illumina公司首席執行官杰伊?弗拉特利將擔任Grail的董事長。他表示，新的血液檢測工作其實在大約18個月以前就已展開。

在一次采訪中，弗拉特利表示：“我們已經取得了巨大的進步，這讓我們有信心達到期望的目標。”

他認為，該公司還需要至少一年的研究和開發來改善血液檢測。隨后，Grail將會在多達30萬個人類基因組上進行臨床測試，這個過程可能需要花費兩年時間。

弗拉特利表示，Illumina計劃在2019年正式將這種檢測方式投入市場，并希望DNA序列測定的成本屆時能降到足夠低的程度，以保證一次癌癥檢查的價格維持在500美元左右，這樣才能讓它得到大范圍的應用。

投資銀行PiperJaffray公司的分析師預計，多達38家公司正在利用DNA序列測定技術來開發癌癥血液檢測手段，不過這些所謂的“液體活組織檢查”基本上只是在已經確診癌癥的病人身上進行測試，看看他們對治療的反應，或是檢測基因突變或耐藥性。

批評者表示，目前還沒有足夠的證據表明血液檢測能夠在健康人身上發現癌癥前兆。Pathway Genomics公司的篩選試驗去年在10個健康人身上檢測出了癌癥，這激怒了美國食品與藥物管理局(FDA)。FDA給該公司寫信表示，這一檢查“還沒有得到充足的臨床驗證，可能對公眾健康有害。”

弗拉特利表示，Grail將盡早征詢FDA的意見，以了解該機構需要什么證據，而且很可能將尋求FDA的認證。他表示，公司還沒決定是否直接將這項測試提供給消費者，但不排除這種可能性。

這筆投資將對Illumina的收益產生重大影響，不過弗拉特利目前沒有透露這方面的信息。他說：“我們將在財報中充分披露與Grail 公司相關的經濟數據。”（財富中文網）

譯者：嚴匡正

審校：任文科

On Sunday, San Diego-based Illumina said it would form a new company, called Grail, with more than $100 million in Series A financing. Illumina will be the majority owner. Key investors include technology giants Bill Gates, founder of Microsoft, and Jeff Bezos, founder of Amazon, as well as backing from ARCH Venture Partners and Sutter Hill Ventures.

So what doesthe company do？

Gene sequencing company Illumina is going after the next big advance in cancer detection, working to develop a universal blood test to identify early-stage cancers in people with no symptoms of the disease.

Grail’s test will use Illumina’s DNA sequencing technology to scan for bits of cancer genes originating in tumors and circulating in the bloodstream. The hope is to detect many types of newly forming cancers, which could be treated at an earlier stage to increase the chances of survival.

Cowen & Co estimates that use of DNA blood tests for cancer screening will exceed $10 billion a year by the end of the decade. Several companies are developing liquid biopsies, mostly for use with patients already diagnosed with cancer.

Experts say it will take huge clinical trials to provide the kind of evidence necessary to make DNA blood tests part of routine cancer screening. Direct-to-consumer testing company Pathway Genomics last year launched a DNA blood test for healthy people without having conducted such trials. Illumina, a much bigger player, intends to provide that evidence.

Illumina CEO Jay Flatley, who will serve as chairman of Grail, said work on the new test began some 18 months ago.

“We’ve made tremendous progress, which gives us the confidence that we can get to the endpoint that we expect,” Flatley said in an interview.

He believes it will take at least an additional year of research and development to refine the test. Grail will then conduct clinical trials of the test on as many as 300,000 human genomes, which could take another two years.

Illumina aims to have its test on the market by 2019 and hopes the cost of DNA sequencing will have dropped enough to price the cancer screening test around $500 each, low enough to make it widely accessible, Flatley said.

PiperJaffray analysts estimated that as many as 38 companies are developing cancer blood tests using DNA sequencing, but most of these so-called “liquid biopsies” use the tests in patients already diagnosed with cancer to see how they are responding to treatment or to check for mutations or drug resistance.

Critics said there is not enough evidence yet that a blood test can screen for cancer in healthy people. Pathway Genomics’ screening test claiming to detect 10 cancers in healthy people drew the ire of the Food and Drug Administration last year, which sent the company a letter saying the test “had not received adequate clinical validation and may harm the public health.”

Flatley said Grail will consult early on with the FDA to see what evidence the agency needs for the test and will likely seek its approval. He said the company has not yet decided whether the test will be offered directly to consumers, but it is possible.

Illumina’s investment will result in a hit to earnings, but Flatley would not say how much at this point. “The actual economics of Grail will be fully disclosed in our financials,” he said.