Treatments for patients on day one
Diagnostics & Clinical Research | therascreen

Treatments for patients on day one

16 November 2020

All local recommended safety guidelines followed at the time of interview.

The availability of new treatment options are key for some cancer patients who may not have time to wait for labs to validate a new test. NeoGenomics, the U.S.’s largest cancer diagnostic company, partnered up with QIAGEN and Novartis to deliver a novel treatment to breast cancer patients on day one, while setting a precedent in the future of diagnostics.

Inside a mirrored, multistory building in an office park in Aliso Viejo, an hour’s drive from Los Angeles, a small team is hard at work opening a never-ending stream of envelopes and boxes containing blood and tissue samples. They work for NeoGenomics, the U.S.’s largest cancer diagnostic company, routing the incoming samples to one of five different laboratories in the building. Hundreds of lab technicians work in shifts around the clock, seven days a week, processing the incoming samples through tests ranging from anatomic pathology to cytogenetics and molecular testing. “We offer tests for all cancers and use whichever technology and test that will give the patient a reliable result in the shortest time possible,” Lawrence Weiss, the company’s chief medical officer, says. 

In recent years, NeoGenomics has seen a marked increase in demand for companion diagnostics (CDx), a specific type of test which determines if a patient is likely to benefit from treatment with a specific targeted cancer therapy, based on the genetic profile of their tumor.  Weiss points to the fact that about one-third of all cancer drugs currently submitted to  the FDA for approval are already paired with such companion diagnostics during their clinical trials. In order for such a targeted therapy to be of immediate benefit to patients, the companion diagnostic needs to be available as soon as the drug is made available on the market. Yet historically, the availability of new companion diagnostic testing services has often lagged behind the launch of new drugs by many months, and sometimes even up to a year.The main cause of this delay is the time required to implement and validate new tests at laboratories. “Companion diagnostics are critical to us,” Weiss explains, “because there’s no point in getting a drug approved and getting patients and the medical community excited if we then have to wait for the diagnostic to be validated.” 

In the past, validation of a new companion diagnostic has taken up to twelve months for postdrug approval, a timespan which has proven fatal to patients in some cases. Dr. Lawrence Weiss, Neogenomics chief medical officer, explains why the Day-One program is crucial and how to successfully launch a drug so it is readily available for patients as soon as possible.
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There’s no point in getting a drug approved and getting patients and the medical community excited if we then have to wait for the diagnostic to be validated.
Dr. Lawrence Weiss, Chief Medical Officer, NeoGenomics

The last chance

Precision medicine is targeted cancer treatments that are transforming patient care.They improve patient survival rates and often have fewer of the debilitating side effects associated with previous forms of chemotherapy. “Being able to do testing right away and offer patients who may be eligible a chance to go on an exciting new drug is a big win for them,” says Weiss. “They might have just a few weeks or months to live, and this could be their last chance.”

Weiss cites one example of how the process of making a new companion diagnostic test available should work: the case of therascreen PIK3CA RGQ PCR Kit. This test detects specific mutations in the PIK3CA gene in samples of tumor tissue, or in blood plasma, taken from patients with advanced or metastatic breast cancer. These mutations are known to lead to the expression of a form of the important cell signaling pathway protein PI3Kinase which is inappropriately activated, and can therefore drive tumor formation and growth. In order to treat such cases of cancer, Novartis developed a novel PI3Kinase inhibitor drug, PIQRAY (alpelisib). The FDA approved the companion pair of both PIQRAY and the QIAGEN therascreen PIK3CA RGQ PCR companion diagnostic kit contemporaneously, in May 2019. These approvals give patients both a new targeted therapeutic option, and a test which can inform them if they are eligible for this treatment within a matter of days of submitting a sample for testing. “It’s opened up this whole era of precision medicine. You’re no longer prescribing a drug for a whole population with the potential for unwanted side effects,” explains Weiss, “but instead can identify a subset of patients who are most likely to respond.

Treatments for patients on day one
Dr. Lawrence Weiss is the chief medical officer at Neogenomics, the U.S.’s largest cancer diagnostic company which supports local pathologists and oncologists by providing all services they are not equipped to offer in their own labs. Weiss’s mission is to ensure that patients and their physicians get test results as quickly as possible so patients can receive timely targeted diagnoses and increase their chances of survival.
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Being able to do testing right away and offer patients who may be eligible for a chance to go on an exciting new drug is a big win for them…this could be their last chance.
Dr. Lawrence Weiss, Chief Medical Officer, NeoGenomics

Day-One Lab Readiness

NeoGenomics is one of the several companies that have partnered with QIAGEN under its Day-One Lab Readiness program. The program enables diagnostic labs to implement the activities necessary to prepare new companion diagnostic testing services for commercial launch before FDA approval is granted, so that once this is in place, testing can be made available as rapidly as possible, supporting identification of patients who are eligible for treatment and therefore the launch of the new drug. And as Weiss says: “PIK3CA is the perfect example of how things should be done. All three parties – Novartis, QIAGEN and we here at NeoGenomics – started talking early and were optimally aligned to have the new test validated according to the very rigorous FDA standards.” Within just a week of the FDA’s approval of the drug and the CDx, NeoGenomics was able to offer the new test to physicians and their patients. “The collaboration between Novartis, QIAGEN and NeoGenomics is a triple win, but most of all, the win is for the patients,” says Weiss. “The volume of PIK3CA tests has grown steadily from an initial 200 tests a month to thousands of such tests in 2019”, Weiss says as he scrolls through a spreadsheet on his computer. With around 4,000 new cases arriving per day, NeoGenomics performs about one million diagnostic tests in a year. “That volume is staggering, even to me,” Weiss admits.

Treatments for patients on day one
The QIAGEN therascreen PIK3CA RGQ PCR Kit is a highly sensitive in-vitro PCR assay, suited even for patients who are hard to biopsy or whose biopsies yield insufficient amounts of tissue. Once the NeoGenomics lab receives the tissue sample, it is fixed in paraffin. Lab technicians use a thin slice to isolate patient DNA and mix it with the kit’s reagents to check for the presence of specific protein biomarkers, telltale signs of cancerous mutations. A second version of the test works with blood plasma samples. Getting the test results usually takes two to three days.
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PIK3CA is the perfect example of how things should be done. All parties were optimally aligned to have the new test validated according to the very rigorous FDA standards.
Dr. Lawrence Weiss, Chief Medical Officer, NeoGenomics

“Having this test available gives hope, not only to newly diagnosed patients but also to existing patients who have had few diagnostic and therapeutic options,” Weiss says. Since the PIK3CA mutation is generally stable, even biopsy samples dating back two or three years are often adequate for testing – opening up new avenues for treatment without the need for further sampling procedures. Under the program, drug maker Novartis is covering the cost of PIK3CA testing. Weiss thinks this speedy and efficient collaboration has set a precedent for future diagnostic tests. From initial talks between the three partners, it took just six months to validate the test and receive final approval. “When you work with the pharmaceutical company and the kit-maker early on, it makes things much easier. This model has been so successful, we hope to emulate it in the future,” he says. This can have a profound impact on how drugs and associated tests are developed and brought to market.

How does QIAGENs Companion Dx (CDx) testing program enable access for patients on Day One?
Find out more about QIAGENs globalization and market access programs for CDx.
The therascreen PIK3CA RGQ PCR Kit is intended for in vitro diagnostic use. Products and product claims may differ from country to country based on regulations and approvals. Contact your country representative for further details.
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