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JP Morgan Healthcare Conference, Day 1: Novartis, Bristol Myers Squibb, Mirati, Johnson & Johnson


SAN FRANCISCO – The 41st Annual JP Morgan Healthcare Conference is being held here in person again after going virtual in 2022 due to the coronavirus pandemic. On the first day, a bolus of companies developing precision oncology drugs and tests provided business updates and previewed what may be coming down the pike. 

Below are brief reports on individual presentations from the conference on Monday.


After announcing plans to spin off its generic medicines division Sandoz earlier this year, Novartis is hammering home its new identity as a 100 percent innovative medicines company focused on advancing drugs in five core therapeutic areas, including solid tumors and hematology. 

In the solid tumor space, which contributed $5 billion in revenue for the Swiss drugmaker in Q3 2022, Novartis is focused on expanding eligible patient populations for its CDK4/6 inhibitor Kisqali (ribociclib) and its prostate-specific membrane antigen-directed radiopharmaceutical Pluvicto (lutetium vipivotide tetraxetan). In December 2022, Novartis presented new data from the Phase II RIGHT Choice trial supporting Kisqali over chemo in the advanced hormone receptor-positive, HER2-negative breast cancer setting. 

The firm is anticipating a final readout from the Phase III NATALEE study, which pits Kisqali against endocrine therapy in early-stage breast cancer, during the second half of 2023. The study has the potential to expand the agent's label significantly, moving beyond the metastatic setting into early-stage cancers. 

As for Pluvicto, Novartis anticipates a full readout from the Phase III PSMAfore study, which pits Pluvicto against androgen receptor pathway inhibitor (ARPI) therapy in metastatic castrate-resistant prostate cancer (mCRPC) patients previously treated with a separate ARPI but not with prior chemo. According to the drugmaker, PSMAfore achieved its primary endpoint. Novartis aims to move Pluvicto into the first-line mCRPC setting, and then into even earlier lines of therapy. According to the firm, the market for the radiopharmaceutical could expand three to four times beyond what it is currently in coming years. 

In the hematology space, the firm wants to expand the STAMP inhibitor Scemblix (asciminib) into a first-line treatment for newly diagnosed chronic myeloid leukemia, a setting in which Novartis is currently conducting the ASCEND IIT trial. According to Novartis, that trial has shown encouraging preliminary efficacy and safety. 

Novartis also highlighted several early pipeline assets, including JDQ443 for KRAS G12C-mutated non-small cell lung cancer. The agent is still investigational, but Novartis presented encouraging data in 2022. 

Meanwhile, Novartis has made some process improvements when it comes to its CAR T-cell therapies. For instance, with the help of a new T-charge platform for CAR T-cell manufacturing, the firm expects to bring down the production time to seven days, down from around a month — the time it currently takes to produce Kymriah (tisagenlecleucel). 

Novartis will report Q4 2022 and full-year financial results on Feb. 1. 

Bristol Myers Squibb 

In 2023, Bristol Myers Squibb remains focused on diversifying its pipeline as loss-of-exclusivity nears for several blockbuster drugs over the next decade, including its checkpoint inhibitor Opdivo (nivolumab). 

Chris Boerner, chief commercialization officer at BMS, highlighted several emerging opportunities for the company in cancer, including the recently launched Opdualag (nivolumab and relatlimab) and the ROS1 inhibitor repotrectinib. 

Boerner noted that Opdualag continued to perform well following its launch last year as a first-line melanoma treatment and noted that the drug currently has captured a percent of the US market share in the high teens. The drug was approved in the US as a first-line treatment in an all-comer melanoma population and in Europe for melanoma patients whose tumors express PD-L1 in fewer than 1 percent of cells. 

"We still have room to grow this product given the fact that PD-1 monotherapy [use], where we expect that the majority of [Opdualag] patients will come from, in first-line melanoma is still between 15 and 20 percent," Boerner said. "As we get more clinical data with this program, Opdualag has the potential to extend our [immune-oncology] franchise well into the next decade." 

In its late-stage pipeline, BMS hopes to achieve key milestones for the ROS1 inhibitor repotrectinib in 2023. BMS acquired repotrectinib through its $4.1 billion acquisition of Turning Point Therapeutics last June. The company is currently studying the drug in the Phase I/II TRIDENT-1 trial in advanced ROS1-positive non-small cell lung cancer and expects to seek US approval in this setting this year. 

Other expected milestones in 2023 include trial readouts for Opdivo in first-line castration-resistant prostate cancer, for Opdualag in first-line NSCLC, and for the CAR T-cell therapies, Breyanzi (lisocabtagene maraleucel) and Abecma (idecabtagene vicleucel), in multiple myeloma, large B-cell lymphoma, and chronic lymphocytic leukemia. 

BMS will report Q4 and full-year 2021 results on Feb. 2. 

Mirati Therapeutics 

Mirati Therapeutics became a commercial-stage company in 2022 with the US approval in December of its KRAS G12C inhibitor Krazati (adagrasib) in advanced or metastatic KRAS G12C-mutant non-small cell lung cancer. 

According to Mirati CEO David Meek, the firm's priority is to establish Krazati as a second-line standard of care treatment for this subset of lung cancer patients, a setting where the new drug would compete with Amgen's Lumakras (sotorasib). Mirati, however, is working to differentiate Krazati from Lumakras in several ways, Meek said. For example, Mirati will educate oncologists about the efficacy profile of Krazati, including its central nervous system (CNS) penetration, and aim to expand the number of patients tested for KRAS G12C mutations in the second-line NSCLC setting. 

"We have a highly experienced [commercial] team within this organization. They know the community oncologists extremely well, and the community oncologists are the ones that treat the vast majority of patients with lung cancer," Meek said. "We have a unique distribution model as well as a customer engagement platform that we think will help us accelerate our launch." 

In Q3, Mirati is anticipating European regulators to make a decision in this same setting, which if positive, will result in Krazati being available in Europe as a second-line treatment for KRAS G12C-mutant NSCLC in 2024. 

Now that Krazati has secured an initial approval in the US, Mirati is pushing ahead with trials to move the drug into earlier treatment lines in NSCLC and in other KRAS G12C-mutant tumors, such as colorectal and pancreatic cancer. The firm is also exploring combination approaches with checkpoint inhibitors and other targeted therapies. 

"These are the value drivers that will build Krazati into a very big product for a very long time," Meek said. 

In the first half of 2023, San Diego-headquartered Mirati is expecting data readouts from studies of Krazati in pancreatic and other solid tumors with KRAS G12C mutations. The firm will meet with the US Food and Drug Administration to discuss potential accelerated approval for Krazati based on the data in third-line KRAS-mutant colorectal cancer. 

In the second half of the year, the firm plans to initiate a Phase III study of Krazati monotherapy and in combination with Merck's Keytruda (pembrolizumab) in first-line KRAS G12C-mutant NSCLC. 

Other than Krazati, Mirati has several early-stage pipeline candidates and expects to begin studies for these agents this year. The firm will begin a Phase I/Ib trial of its KRAS G12D inhibitor, MRTX1133, in KRAS G12D-mutant solid tumors early this year, with planned expansion cohorts in pancreatic, colorectal, and lung cancer. In the second half of 2023, the firm will begin a Phase I trial of Krazati in combination with its SOS1 inhibitor MRTX0902. 

The company is also expecting data readouts in 2023 from a Phase III trial of the oral spectrum-selective kinase inhibitor sitravatinib plus Bristol Myers Squibb's Opdivo (nivolumab) and from a Phase I/II study of its PRMT5 inhibitor MRTX1719 in MTAP-deleted cancers. 

As of the end of 2022, Mirati had $1.1 billion in cash and cash equivalents, which Meek said will fund operations through 2025. 

Johnson & Johnson 

Johnson & Johnson CEO Joaquin Duato discussed how several precision oncology assets in the firm's pipeline will be part of a plan to bring in $60 billion in drug revenues by 2025 and make up for the patent expiration of the Crohn's disease drug Stelara (ustekinumab) in 2023. J&J will fuel its growth through increased sales of its currently marketed products and new products launches, Duato said. 

Among the anticipated product launches is a combination treatment comprising the c-Met/EGFR antibody Rybrevant (amivantamab) and the third-generation EGFR tyrosine kinase inhibitor lazertinib in EGFR-mutated non-small cell lung cancer, as well as the bispecific T-cell engager talquetamab in multiple myeloma. J&J will also work to expand indications for approved products including its BCMA-directed CAR T-cell therapy Carvykti (ciltacabtagene autoleucel) and its BCMA-CD3 bispecific antibody Tecvayli (teclistamab). 

Duato anticipates that J&J will be able to expand its therapeutic presence in multiple myeloma, where the drugmaker is focusing on shifting from developing treatments that stave off progression to making therapies that cure the disease. A readout is expected soon from the Phase III CARTITUDE-4 trial, which could support using Carvykti as an earlier-line multiple myeloma treatment, Duato said. That trial is comparing Carvykti against standard chemotherapy in multiple myeloma patients who have received one to three prior lines of therapy. 

"That's going to give you an idea of how a medicine like Carvykti could move into earlier lines of therapy and could become a mainstay of treatment for multiple myeloma," Duato said, adding that he believes Wall Street is missing the synergistic potential of J&J's multiple myeloma portfolio, which includes Darzalex (daratumumab) as a first-line therapy, plus Carvykti, Tecvayli, and talquetamab for later lines of treatment. 

These drugs "cannot be cannibalizing each other, but [are] creating treatment paradigms that are different by combining and sequencing different medicines," Duato said. "That's a growth factor we have to take into consideration." 

Likewise, Duato sees much potential in Rybrevant-lazertinib combination in first-line EGFR-mutant NSCLC. J&J's Phase III MARIPOSA trial will evaluate the combo against AstraZeneca's Tagrisso (osimertinib) in about 1,000 patients with locally advanced or metastatic EGFR-mutated NSCLC. Final results from that trial are expected in 2024, but an interim analysis is slated to read out in 2023. 

Despite near-term and long-term growth opportunities, Duato acknowledged that challenging global macroeconomic conditions may put pressure on the company's medtech and pharmaceuticals businesses to grow in a softer pharmaceutical market compared to the last two years. 

Gilead Sciences 

Gilead Sciences' oncology business has an annual run-rate of more than $2 billion, according to Gilead CEO Daniel O'Day. The Foster City, California-based firm has confidence in its cell therapy pipeline and in being able to expand the use of the antibody-drug conjugate Trodelvy (sacituzumab govitecan). 

The drugmaker is expecting a regulatory decision from the US Food and Drug Administration on Trodelvy in metastatic hormone receptor-positive, HER2-negative breast cancer during the first half of this year — perhaps as soon as next month — based on the results of the Phase III TROPiCS-02 trial. That approval would expand the label significantly for Trodelvy, which is presently approved in the US for advanced triple-negative breast cancer and metastatic urothelial cancer. 

O'Day added that the firm also has confidence in its ability to move the agent into earlier treatment settings. This year, the firm will begin enrolling HR-positive, HER2-negative breast cancer patients to the ASCENT-07 trial, in which they'd receive Trodelvy as first- or second-line treatment. 

Gilead is also focusing on bringing Trodelvy and other drugs to lung cancer patients. In collaboration with Arcus Biosciences, Gilead presented positive Phase II data on their anti-TIGIT molecule domvanalimab in advanced, PD-L1-high non-small cell lung cancer patients in December. 

Gilead is also focused on continually growing its cell therapy business via Kite Pharma. Toward that end, in late 2022, the firm announced it would acquire the CAR T-cell therapy biotech Tmunity Therapeutics. This came shortly after it announced a collaboration with Arcellx to develop a B-cell maturation antigen-targeted CAR T-cell therapy in multiple myeloma. 


Erasca CEO Jonathan Lim estimated that there are 5.5 million patients worldwide who can benefit from RAS/MAP kinase pathway inhibitors, and there are no approved targeted therapies currently for 70 percent of that market. As a drug company entirely focused on RAS/MAP kinase-driven cancers, Erasca wants to develop treatments particularly in areas of unmet need but also in more competitive markets. 

For example, in December, the San Diego-based firm paid Novartis $20 million upfront and $80 million worth of Erasca shares to gain the exclusive worldwide rights to develop and commercialize the BRAF/CRAF inhibitor naporafenib. Novartis can receive up to $80 million in cash upon achievement of regulatory milestones for two indications in the US, Europe, and Japan; up to $200 million in cash if certain sales milestones are reached; and a low-single-digit percentage royalty on net sales of the drug. 

The drug has demonstrated proof-of-concept activity in NRAS Q61X-mutated melanoma with an objective response rate of 44 percent in 16 patients, and in KRAS Q61X-mutated NSCLC, two out of three patients responded to the drug. "That bodes well as we consider expanding this to a tissue-agnostic trial, which is really the undergirding of SEACRAFT-1," Lim said, noting that the company is planning to pair naporafenib with Novartis' MEK inhibitor Mekinist (trametinib) and track patients' objective responses and duration of response. 

Erasca wants to also seek approval for a naporafenib plus Mekinist combo in NRAS-mutated metastatic melanoma based on findings from the Phase III SEACRAFT-2 trial. This study will randomize patients to the combination regimen or physician's choice of chemotherapy and track their progression-free survival, overall survival, and responses. The current standard of care after immunotherapy in this setting is chemotherapy, which staves off progression for a median of 1.5 months and shrinks tumors in 7 percent of patients. In comparison, Lim highlighted that when naporafenib was combined with Mekinist in a Phase I trial involving heavily pretreated NRAS-mutated melanoma patients, 47 percent of patients responded and 80 percent experienced disease control. 

Then, in the SEACRAFT-3 trial, Erasca is exploring naporafenib's activity in solid tumors with NF1 loss of function and pan-RAS G13R, KRAS G12C, and BRAF mutations. 

Naporafenib is the latest addition to Erasca's clinical pipeline, which features the ERK1/2 inhibitor ERAS-007 being studied in RAS/MAPK-altered solid tumors including gastrointestinal and NSCLC; the SHP2 inhibitor ERAS-601 in RAS/MAPK-altered tumors; ERAS-801 in EGFR-altered glioblastoma; and ERAS-3490 in KRAS G12C-mutated solid tumors. "Our pipeline allows us to target every node in the [RAS/MAPK] pathway … alone and in combination with standard of care as well as with each other," Lim said. 

The company is expecting a data readout in H1 from a HERKULES-2 sub-study of ERAS-007 plus AstraZeneca's Tagrisso (osimertinib) in EGFR-mutated NSCLC following Tagrisso treatment. Lim said the company has discontinued enrollment in another sub-study in HERKULES-2 exploring ERAS-601 plus Amgen's Lumakras (sotorasib) in KRAS G12C-mutated NSCLC in order to prioritize other opportunities. 

The company had $365 million in cash, cash equivalents, and short-term marketable securities as of Sept. 30, 2022. 


Merck is counting on partnerships and licensing deals to diversify its oncology portfolio and limit its reliance on the blockbuster Keytruda (pembrolizumab) as patent expirations loom. "We are here [at the JP Morgan Healthcare Conference] because we are looking for partners," said Dean Li, president of Merck Research Laboratories. "We encourage all of these partners to come see us because we're open for business and are interested in advancing our pipeline." 

Over the last five years, Merck has spent $36.5 billion on business development activities, including investing in partnerships that can add new revenue streams from oncology assets. For instance, last year, Merck partnered with Moderna to evaluate a personalized mRNA cancer vaccine candidate in combination with Keytruda. The combination has demonstrated encouraging efficacy as an adjuvant treatment for melanoma patients, and the drugmakers plan to move the combination into a Phase III trial as well as study its activity in earlier stages of melanoma and in other immune-sensitive tumors such as non-small cell lung cancer. 

Merck CEO and Chairman Rob Davis added that new antibody-drug conjugates, brought in through a recent deal with Kelun-Biotech, and other small molecules also present an opportunity to capture more than $10 billion in revenue. 

Day One Biopharmaceuticals 

Following a positive readout from a pivotal Phase II trial, Day One Biopharmaceuticals is preparing to file a new drug application this year with the US Food and Drug Administration for its lead agent tovorafenib as a treatment for recurrent or progressive pediatric low-grade glioma. 

The South San Francisco, California-based firm reported that in the FIREFLY-1 trial, 64 percent of 69 heavily pretreated pediatric patients between the ages of 6 months and 25 years responded to tovorafenib; 91 percent experienced a clinical benefit on the drug. The median duration of treatment was 8.4 months, with 77 percent still on the drug as of Sept. 28, 2022. "This is very encouraging data for us to move forward into the next steps of this program, which will be to review the dataset in a pre-NDA meeting with the FDA and prepare for an NDA filing in the first half of this year," said Day One CEO Jeremy Bender. 

In FIREFLY-1, 59 patients had a BRAF fusion, against which there are no approved systemic therapies, and 10 had a BRAF mutation. Two of the three patients who discontinued treatment did so due to adverse events from tovorafenib. Day One will present additional data at a medical meeting in Q2 2023. 

Most young patients with low-grade gliomas tend to have indolent tumors that can be removed with surgery, but recurrent or progressive tumors lack a standard of care and often require multiple lines of systemic therapy. The majority of patients with these tumors have a BRAF wild-type fusion and a minority have a BRAF V600E mutation. As a type II RAF inhibitor, tovorafenib is designed to target tumors with both of these types of alterations, whereas type I RAF inhibitors inhibit only BRAF V600E mutations. 

Other than the development program in recurrent pediatric low-grade glioma, Day One is also exploring the activity of tovorafenib as a frontline treatment for patients newly diagnosed with these brain tumors and expects to begin dosing patients in the pivotal FIREFLY-2 trial in the first quarter. Day One believes tovorafenib could also be effective against tumors that occur outside the brain after a 5-year-old boy with spindle cell sarcoma received the drug through its compassionate use program and achieved a complete response. As such, the firm is also studying the drug as a monotherapy in RAF-altered solid tumors and in combination with the MEK1/2 inhibitor pimasertib in MAPK-altered solid tumors in the FIRELIGHT-1 trial. 

As of Sept. 30, 2022, Day One had $374.3 million in cash, cash equivalents, and short-term investments.

Guardant Health 

Guardant Health executives emphasized the deployment of the company's so-called "smart" liquid biopsy platform, which Cofounder and co-CEO Helmy Eltoukhy called a "quantum leap forward." The platform combines liquid biopsy with new multimodal chemistry that allows one to see genomics and epigenomics data simultaneously to improve performance, making it 50 times more sensitive than Guardant360 CDx and expanding the breadth of genomic data at the same cost of goods. 

The Guardant Shield screening test and GuardantInfinity research test already utilize the technology, and Eltoukhy announced that Guardant Reveal will be upgraded to the platform this year. The upgrade will provide a "massive sensitivity boost" by looking at more than 1,000 biomarkers, and the firm is also planning on upgrading the rest of its portfolio, he said. While the Reveal upgrade is "intricate" because it involves many lines of the business, such as reimbursement, Eltoukhy said the firm has mapped the transition out well and is confident it can go smoothly. 

"We're really excited about the consolidation … and the leverage this gives us across our entire portfolio, because it's a unified technology base, unified operational base, and it's really kind of leverage that few companies have seen in this industry," he said. 

Meantime, co-CEO AmirAli Talasaz said that the firm plans to complete its FDA premarket application for the Guardant Shield test for colorectal cancer screening in Q1 2023 and expects approval and the launch of the test as an in vitro diagnostic in 2024. Last month, the company released data from its ECLIPSE trial showing the test had sensitivity of 83 percent and specificity of 90 percent, with 13 percent sensitivity for advanced adenomas. Guardant's share price took a beating after the announcement as sensitivity came in below expectations, but the data will still support regulatory approval and Medicare reimbursement, Talasaz said. 

Enrollment for a multisite, 10,000-patient study for the Shield test for lung cancer began in 2022 and will have its first endpoint readout in 2025, he added. The test will possibly be submitted to the FDA in 2026. Guardant is also expecting a data readout from the 600-patient NCIRE-LUNG prospective study on the test toward the end of 2023 or beginning of 2024, Talasaz said. The company is working on a Shield panel for other cancer indications, as well. Eventually, the firm expects potential volume of 10 million Shield colorectal cancer screening tests per year in 2032 with a $5 billion sales potential, Talasaz said. 

Expanding on Guardant's preliminary Q4 earnings results announced Monday morning, Talasaz said that this was the firm's "peak year in terms of cash burn," but now that its core infrastructure is established, Guardant can start to gain material leverage from it. The company expects to reduce its cash burn by about $50 million in 2023, from $400 million in 2022, he added. In addition, the Guardant360 business is on track to break even in about a year. The precision oncology business, encompassed by the Guardant360 franchise, saw revenue growth of 28 percent year over year. 

Guardant also saw an acceleration of volume in 2022 for the Reveal test, with clinical volume growth of more than 250 percent year over year, Eltoukhy added. 

Adaptive Biotechnologies 

Adaptive Biotechnologies CEO Chad Robins presented his company's focused strategy, emphasizing the twin pillars of minimal residual disease (MRD) testing for hematologic cancers and immune medicine. The goals, he said, are to increase the penetration of the firm's next-generation sequencing-based ClonoSeq test in both the clinical testing and pharmaceutical markets and to drive opportunities in drug discovery. 

Full-year 2022 revenues for the company's MRD testing segment, which includes the ClonoSeq test for physicians and ClonoSeq assay for pharmaceutical companies, are estimated to be greater than $80 million, up 45 percent from $56 million in 2021. The company's compound annual growth rate from 2022 to 2027 is expected to be in the 20 to 30 percent range, Robins said. 

The firm is also working to expand the use of ClonoSeq with blood instead of bone marrow, Robins said. About 30 percent of ClonoSeq tests are used with blood but working with blood samples makes the assay easier to adopt and can increase testing frequency, he added. The company has nine ongoing studies over the next three years to generate more data about ClonoSeq's use with blood samples, he said. At least one of the studies validating the use of the test with blood in multiple myeloma is expected to have a data readout this year. 

Nitin Sood, the company's chief commercial officer for MRD, said that he expects 50 percent growth in MRD test volumes and single digit growth in average selling price in 2023. 

Adaptive is also planning to expand ClonoSeq's indications to non-Hodgkin's lymphoma. About 50 percent of patients eligible for ClonoSeq have non-Hodgkin's lymphoma, with 30 percent of those patients having diffuse large B-cell lymphoma, Robins said. Adaptive already offers the test in its CLIA laboratory and has Medicare reimbursement, but it plans to seek FDA clearance for the indication in 2023. The firm is pursuing FDA approval because it will help with guideline inclusion and because pharmaceutical partners want a test with regulatory approval, Robins said. 

On its immune medicine side, the company is aiming to drive growth in immune receptor sequencing for pharma services and in target discovery, T-cell therapeutics, and antibody therapeutics for drug discovery, he said. Pharmaceutical companies are able to use Adaptive's ImmunoSeq solution to look at a patient's immune profile to see how a drug is impacting the person, Robins said. 

Robins said the company's drug-discovery efforts are focused on cancer and autoimmune disorders and that its platform is able to both validate novel disease-specific drug targets and then find immune receptors that can be used as therapeutics against those targets. The firm has two cancer products: a T-cell therapy containing a T-cell receptor that targets a shared cancer neoantigen, and a T-cell therapy with multiple receptors targeting a patient's unique tumor neoantigen. The first therapy was developed with Roche subsidiary Genentech, which is pursuing an investigational new drug application with the FDA, Robins said. 

Exact Sciences 

Exact Sciences CEO Kevin Conroy emphasized the company's growth and momentum, particularly with regards to profitability. The firm is expected to become profitable in 2023, ahead of previous guidance of achieving profitability in 2024, he noted. In its preliminary financial results released on Monday, the firm reported a year-over-year increase of 16 to 17 percent in Q4 revenues, and an 18 percent increase in full-year 2022 revenues. Conroy said he believes the results are sustainable and that some of the key drivers of the Q4 growth come from longer-term investments, such as brand awareness, test quality, and the commercial team. Exact CFO and Chief Operating Officer Jeff Elliott added that, because of those longer-term investments, sales and marketing costs should be flat or down in 2023. 

While market penetration of the Oncotype Dx Breast Recurrence Score is strong in the US, Conroy noted, the company is also planning to expand the assay to more countries in 2023, where there is opportunity for growth. 

Exact Sciences is planning to launch the test in Japan and will try to increase uptake in India and Brazil, he said. Japan could also potentially be the largest source of revenues for the test outside the US, Elliott added. The test received approval from Japan's Ministry of Health, Labor, and Welfare in 2021. Elliott noted that the firm already does business in 90 countries, so the foundation is there to build out further uptake of the test. 

In addition, Conroy provided more information on the multi-cancer blood-based test Exact is developing. He said the timeline for the test is unknown but will take "a number of years," and noted that the company will likely seek approval from the US Food and Drug Administration for the assay, rather than offering it as a laboratory-developed test.